Acute Lymphoblastic Leukemia (ALL) is a cancer of the white blood cells. It is characterized by the rapid proliferation of abnormal, immature lymphocytes, known as lymphoblasts, in the bone marrow. This accumulation of blasts in the marrow prevents the formation of healthy red blood cells, white blood cells and/or platelets. Normal lymphoblasts develop into B and T lymphocytes that fight infection. In ALL, the leukemic lymphoblasts do not fully develop and therefore cannot fight infection. The symptoms of ALL are caused by the replacement of normal bone marrow with leukemic cells, resulting in a drop in red blood cells, platelets, and normal white blood cells. It is estimated that 80-85% of ALL cases occur in children, with peak incidence of pediatric ALL at age 5. Biologically, adult and pediatric ALL are very different. Pediatric cases are more often characterized by favorable prognostic indicators including a precursor B-cell population, TEL / AML1 fusion gene, and/or hyperdiploidy; adult cases are more often characterized by poor prognostic indicators including a precursor T-cell population and / or BCR / ABL fusion gene.1

1 Sallan S. Myths and Lessons from the Adult/Pediatric Interface in Acute Lymphoblastic Leukemia. ASH Education Book, 1st edition. 2006:128-32.

Question 96: Specify ALL classification

Indicate the disease classification at diagnosis.

Due to the aggressive nature of precursor T- and precursor B-cell lymphoblastic lymphoma (or lymphoma / leukemia), the primary disease reported for recipients with these malignancies should be acute lymphoblastic leukemia.

If the cytogenetic or molecular abnormalities present at diagnosis are listed on the Pre-TED form, check the sub-type rather than “B-cell ALL, NOS” option.

Question 97: Did the recipient have a predisposing condition?

A predisposing condition is a condition that contributes to the susceptibility of developing leukemia. Therefore, diagnosis of the condition increases the likelihood that the recipient will develop leukemia. If the recipient has a documented history of a predisposing condition, check “Yes” and continue with question 98. If there is no history of a predisposing condition or if predisposition is unknown, indicate “No” or “Unknown” and continue with question 100.

Question 98-99: Specify condition:

Aplastic anemia is an acquired or inherited disorder of the bone marrow characterized by pancytopenia, where the body does not produce a sufficient number of new blood cells. Inherited aplastic anemias include Fanconi anemia (specified separately on this form), Shwachman-Diamond anemia, Diamond-Blackfan anemia, and dyskeratosis congenita. Acquired aplastic anemia may develop after exposures to toxins, radiation, and/or chemotherapy, or may result from an autoimmune condition such as systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). The majority of presenting signs and symptoms in aplastic anemia patients are directly related to their low blood counts and include fatigue, dizziness, shortness of breath, abnormal bleeding or bruising, and frequent infections.

Bloom syndrome is an autosomal recessive genetic disorder characterized by excessive chromosome breakage and corresponding rearrangements, proportional dwarfism, and sun sensitivity. The chromosomal instability seen in Bloom syndrome is generally assumed to be responsible for these individuals’ predisposition to malignancy.

Down syndrome is also a chromosomal disorder (trisomy 21). It is characterized by an additional chromosome 21. Down syndrome patients exhibit a particular set of facial characteristics, growth deficiency, and cognitive impairment. Although Down syndrome patients have a reduced risk of developing many common malignancies, they have an increased risk of developing leukemia.

Fanconi anemia is a rare genetic blood disorder that prevents the body from producing a sufficient number of new blood cells to function properly. Abnormal blood cells may also be produced. These patients are short in stature, exhibit skeletal anomalies, and have an increased risk of developing solid tumors and leukemias.

Indicate the recipient’s predisposing condition prior to the diagnosis of leukemia. If the recipient has a documented history of a predisposing condition but it is not listed as an option in question 98, select “Other condition” and specify the condition in question 99.

Question 100: Were tyrosine kinase inhibitors (i.e., imatinib mestylate) given for pre-HCT therapy at any time prior to the start of the preparative regimen?

Report whether the recipient received any tyrosine kinase inhibitor from the diagnosis of ALL to the start of the preparative regimen / infusion. Examples include: Imatinib mesylate is also known as Gleevec, Glivec, STI-571, or CGP57148B.

This question is optional for international centers.

Question 101: Were cytogenetics tested (conventional or FISH)? (at diagnosis)

Cytogenetic analysis is the study of chromosomes. Cytogenetic assessment involves testing blood or bone marrow for the presence of a known chromosomal abnormality which reflects the recipient’s disease. Testing methods you may see include conventional chromosome analysis (karyotyping) or fluorescence in situ hybridization (FISH). For more information about cytogenetic testing and terminology, see Appendix C, Cytogenetic Assessments.

Karyotyping is performed by culturing cells (growing cells under controlled conditions) until they reach the dividing phase. Techniques are then performed to visualize the chromosomes during cell division so that various bands and reconfigurations can be seen. Banding pattern differentiation and chromosomal reconfiguration demonstrate evidence of disease.

FISH is a sensitive technique that assesses a large number of cells. This technique uses special probes that recognize and bind to fragments of DNA. These probes are mixed with cells from the recipient’s blood or bone marrow. A fluorescent “tag” is then used to visualize the binding of the probe to the diseased cells.

Table 5. Examples of ALL Cytogenetic Findings Categorized by Prognosis (Adult Precursor B-cell ALL)

Favorable Intermediate Poor Very Poor
High hyperdiploidy (51-65 chromosomes) Normal
11q abnormalities
del(6q)
del(17p)
del(9p)
del(12p)
-13/del(13q)
t(14q32)
t(10;14)
Low hyperdiploidy (47-50 chromosomes)
Tetraploidy (> 80 chromosomes)
-7/del(7p)
+8
11q23 abnormalities/MLL
t(1;19)
t(17;19)
t(5;14)
t(9;22)
≥ 5 abnormalities
t(4;11)
t(8;14)

2 Pullarkat V, Slovak ML, Kopecky KJ, Forman SJ, Appelbaum FR. Impact of cytogenetics on the outcome of adult acute lymphoblastic leukemia: results of Southwest Oncology Group 9400 study. Blood. 2008;111(5):2563-72.

Indicate whether cytogenetic studies were performed at diagnosis. Do not report any testing performed after treatment for ALL has started. If cytogenetic studies were obtained at diagnosis, check “Yes” and go to question 102. If cytogenetic studies were not obtained at this time point or it is not known whether chromosome studies were performed, indicate “No” or “Unknown” respectively and go to question 115.

Question 102-103: Were cytogenetics tested via FISH?

If FISH studies were performed at diagnosis (see note box above question 95), report “Yes” for question 102 and indicate whether clonal abnormalities were detected in question 103. Do not report any testing performed after treatment for ALL has started. If FISH studies were not performed at this time point, report “No” for question 102 and go to question 108. Examples of this include: no FISH study performed, or FISH sample was inadequate.

Report chromosomal microarrays / chromosomal genomic arrays as FISH assessments.

Question 104-107: Specify cytogenetic abnormalities (FISH)

Report the International System for Human Cytogenetic Nomenclature (ISCN) compatible string if applicable in question 104, then continue with question 105.

Report the number of abnormalities detected by FISH at diagnosis (see note box above question 101) in question 105. After indicating the number of abnormalities in question 105, select all abnormalities detected in questions 106-107.

If a clonal abnormality is detected, but not listed as an option in question 106, select “Other abnormality” and specify the abnormality in question 107. If multiple “Other abnormalities” were detected, report “see attachment” in question 107 and attach the final report(s) for any other abnormalities detected. For further instructions on how to attach documents in FormsNet3SM, refer to the Training Guide.

Question 108-109: Were cytogenetics tested via karyotyping?

If karyotyping was performed at diagnosis (see note box above question 101), report “Yes” for question 108 and indicate whether clonal abnormalities were detected in question 109. Do not report any testing performed after treatment for ALL has started. If karyotyping was not performed at this time point, indicate “No” and go to question 115. Examples of this include: karyotyping was not performed or karyotyping sample was inadequate.

Question 110-113: Specify cytogenetic abnormalities (karyotyping)

Report the International System for Human Cytogenetic Nomenclature (ISCN) compatible string if applicable in question 110, then continue with question 111.

Report the number of abnormalities detected by karyotyping at diagnosis (see note box above question 101) in question 111. After indicating the number of abnormalities in question 111, select all abnormalities detected in questions 112-113.

If a clonal abnormality is detected, but not listed as an option in question 112, select “Other abnormality” and specify the abnormality in question 113. If multiple “Other abnormalities” were detected, report “see attachment” in question 112 and attach the final report(s) for any other abnormalities detected. For further instructions on how to attach documents in FormsNet3SM, refer to the Training Guide.

Question 114: Was documentation submitted to the CIBMTR?

Indicate if a karyotyping or FISH testing report is attached to support the cytogenetic findings reported in questions 101-113. For further instructions on how to attach documents in FormsNet3SM, refer to the Training Guide.

Question 115: Were tests for molecular markers performed (e.g., PCR)? (at diagnosis)

Molecular markers for disease refer to specific genetic sequences which are believed to be associated with the recipient’s primary disease. Testing for these sequences is often performed using PCR based methods; however, lower sensitivity testing, including FISH, may also be used to detect molecular markers. Once a marker has been identified, these methods can be repeated to detect minimal residual disease (MRD) in the recipient’s blood, marrow, or tissue. Molecular assessments include polymerase chain reaction (PCR) amplification to detect single specific disease markers; however, molecular methods are evolving and now include Sanger sequencing, and next generation sequencing (e.g., Illumina, Roche 454, Proton / PGM, SOLiD).

If testing for molecular markers was performed at diagnosis (see note box above question 101), report “Yes” and go to question 116.

If molecular marker testing was not performed at diagnosis or it is not known if testing was done, report “No” or “Unknown” respectively and go to question 120.

Table 6. Common Molecular Markers Associated with ALL

Molecular Abnormality Characteristics
BCR-ABL BCR-ABL, aka Philadelphia chromosome, refers to the tyrosine kinase gene fusion resulting from the translocation of material from chromosome 9 (ABL) onto chromosome 22 (BCR). Molecular weight varies depending on exact location of the translocation; isoform p190 is typically seen in ALL. Tyrosine kinase inhibitor therapies such as imatinib mesylate (Gleevec) target and block ABL from fusing with BCR. Presence of BCR-ABL gene fusion is associated with poorer outcomes.3
TEL-AML/AML1 TEL-AML1, aka ETV6-RUNX1, is a fusion gene resulting from the translocation of chromosomes 12 and 21. It is the most common fusion gene seen in childhood precursor B-cell ALL. Research in murine models shows that cell lines expressing TEL-AML1 proliferate more slowly than the non-expressing cell lines, but evade inhibition of proliferation typically regulated by tissue growth factor ß (TGF-ß), ultimately leading to the growth of the leukemic cell population. TEL-AML1 is considered a favorable prognostic indicator.45
Other molecular marker Assessments for other molecular markers known or believed to be associated with ALL may be performed. If these studies were performed, indicate “positive” or “negative” and specify the marker in question 99.

3 Wassmann B, Pfeifer H, Scheuring UJ, et al. (2004). Early prediction of response in patients with relapsed or refractory Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) treated with imatinib. Blood, 103(4):1495-8.

4 Ford AM, Palmi C, Bueno C, et al. (2009). The TEL-AML1 leukemia fusion gene dysregulates the TGF-ß pathway in early B lineage progenitor cells. J Clin Invest, 119(4):826-36.

5 Jamil A, Kahwash S, Ruymann FB, Klopfenstein KJ. (2000). TEL/AML-1 fusion gene: its frequency and prognostic significance in childhood acute lymphoblastic leukemia. Cancer Genet Cytogenet, 122(2):73-8.

Question 116-119: Specify results

For each molecular marker in questions 116-117, report whether testing was “Positive,” “Negative,” or “Not done” at diagnosis (see note box above question 101). If tests identified a molecular marker other than those listed in questions 116-117, report the result in question 118 and specify the marker in question 119.

If multiple “Other molecular marker[s]” were tested, report one instance (i.e., copy) of question 118-119 for each “Other molecular marker” tested. If greater than 3 “Other molecular marker[s]” were tested, do the following:

  • report one instance of question 118-119; and
  • report “Positive” if any of the “Other molecular marker[s]” were positive, otherwise, report “Negative;” and
  • report “see attachment” in question 119; and
  • attach any / all reports documenting the results of testing for “Other molecular marker[s].”

Question 120: Were cytogenetics tested (karyotyping or FISH)? (between diagnosis and last evaluation)

See question 101 for a description of cytogenetic tests. Indicate whether cytogenetic studies were performed between diagnosis and the last evaluation prior to HCT / cellular therapy (see note above question 101). If cytogenetic studies were obtained during this time, check “Yes” and go to question 121. If cytogenetic studies were not obtained at this time point or it is not known whether chromosome studies were performed, indicate “No” or “Unknown” respectively and go to question 134.

Question 121-122: Were cytogenetics tested via FISH?

If FISH studies were performed between diagnosis and the last evaluation prior to Infusion (see note box above question 101), report “Yes” for question 121 and indicate whether clonal abnormalities were detected in question 122. If multiple FISH assessments were performed, report “Abnormalities Identified” if any testing showed clonal abnormalities during this period. If FISH studies were not performed during this period, report “No” for question 121 and go to question 127. Examples of this include: no FISH study performed, or all FISH samples were inadequate.

Report chromosomal microarrays / chromosomal genomic arrays as FISH assessments.

Question 123-126: Specify cytogenetic abnormalities (FISH)

Report the International System for Human Cytogenetic Nomenclature (ISCN) compatible string if applicable in question 123, then continue with question 124.

Report the number of abnormalities detected by FISH between diagnosis and the last evaluation prior to Infusion (see note box above question 101) in question 124. If FISH studies showed different clonal abnormalities during this time, report the total number of clonal abnormalities detected. After indicating the number of clonal abnormalities in question 124, select all clonal abnormalities detected during this period in questions 125-126. This includes all clonal abnormalities detected any FISH assessment performed during this period.

If a clonal abnormality is detected, but not listed as an option in question 125, select “Other abnormality” and specify the abnormality in question 126. If multiple “Other abnormalities” were detected, report “see attachment” in question 126 and attach the final report(s) for any other abnormalities detected. For further instructions on how to attach documents in FormsNet3SM, refer to the Training Guide.

Question 127-128: Were cytogenetics tested via karyotyping?

If karyotyping was performed between diagnosis and the last evaluation prior to Infusion (see note box above question 101), report “Yes” for question 127 and indicate whether clonal abnormalities were detected in question 128. If multiple karyotypes were performed, report “Abnormalities Identified” if any testing showed clonal abnormalities during this period. If karyotyping was not performed during this period, report “No” for question 127 and go to question 133. Examples of this include: no karyotyping performed or all karyotype samples were inadequate.

Question 129-132: Specify cytogenetic abnormalities (karyotyping)

Report the International System for Human Cytogenetic Nomenclature (ISCN) compatible string if applicable in question 129, then continue with question 130.

Report the number of abnormalities detected by karyotyping between diagnosis and the last evaluation prior to Infusion(see note box above question 101) in question 130. If karyotype studies showed different clonal abnormalities during this time, report the total number of clonal abnormalities detected. After indicating the number of clonal abnormalities in question 130 select all clonal abnormalities detected during this period in questions 131-132. This includes all clonal abnormalities detected any karyotype performed during this period.

If a clonal abnormality is detected, but not listed as an option in question 131, select “Other abnormality” and specify the abnormality in question 132. If multiple “Other abnormalities” were detected, report “see attachment” in question 132 and attach the final report(s) for any other abnormalities detected. For further instructions on how to attach documents in FormsNet3SM, refer to the Training Guide.

Question 133: Was documentation submitted to the CIBMTR?

Indicate if a karyotyping or FISH testing report is attached to support the cytogenetic findings reported in questions 120-132. For further instructions on how to attach documents in FormsNet3SM, refer to the Training Guide.

Question 134: Were tests for molecular markers performed (e.g., PCR)? (between diagnosis and last evaluation)

See question 115 for a description of testing for molecular markers. Indicate whether testing for molecular markers was performed between diagnosis and the last evaluation prior to Infusion(see note above question 101). If testing for molecular markers was performed during this time, check “Yes” and go to question 135. If molecular markers were not obtained during this period or it is not known whether testing for molecular markers was performed, indicate “No” or “Unknown” respectively and go to question 139.

Question 135-138: Specify results

For each molecular marker in questions 135-136, report whether testing was “Positive,” “Negative,” or “Not done” between diagnosis and the last evaluation prior to Infusion (see note box above question 101). If tests identified a molecular marker other than those listed in questions 135-136, report the result in question 137 and specify the marker in question 138.

If multiple “Other molecular marker[s]” were tested, report one instance (i.e., copy) of question 137-138 for each “Other molecular marker” tested. If greater than 3 “Other molecular marker[s]” were tested, do the following:

  • report one instance of question 137-138; and
  • report “Positive” if any of the “Other molecular marker[s]” were positive, otherwise, report “Negative;” and
  • report “see attachment” in question 138; and
  • attach any / all reports documenting the results of testing for “Other molecular marker[s].”

Question 139: Were cytogenetics tested (karyotyping or FISH)? (at last evaluation)

See question 101 for a description of cytogenetic testing. Indicate whether cytogenetic studies were performed at the last evaluation prior to infusion (see note box above question 101). Do not report any testing performed after treatment for ALL has started. If cytogenetic studies were obtained at this time point, check “Yes” and go to question 139. If cytogenetic studies were not obtained at this time point or it is not known whether chromosome studies were performed, indicate “No” or “Unknown” respectively and go to question 153.

Question 140-141: Were cytogenetics tested via FISH?

If FISH studies were performed at the last evaluation prior to HCT / cellular therapy (see note box above question 101), report “Yes” for question 140 and indicate whether clonal abnormalities were detected in question 141. If FISH studies were not performed at this time point, report “No” for question 140 and go to question 146. Examples of this include: no FISH study performed or FISH sample was inadequate.

Report chromosomal microarrays / chromosomal genomic arrays as FISH assessments.

Question 142-145: Specify cytogenetic abnormalities (FISH)

Report the International System for Human Cytogenetic Nomenclature (ISCN) compatible string if applicable in question 142, then continue with question 143.

Report the number of abnormalities detected by FISH at the last evaluation prior to infusion (see note box above question 101) in question 143. After indicating the number of abnormalities in question 132, select all abnormalities detected in questions 144-145.

If a clonal abnormality is detected, but not listed as an option in question 144, select “Other abnormality” and specify the abnormality in question 145. If multiple “Other abnormalities” were detected, report “see attachment” in question 145 and attach the final report(s) for any other abnormalities detected. For further instructions on how to attach documents in FormsNet3SM, refer to the Training Guide.

Question 146-147: Were cytogenetics tested via karyotyping?

If karyotyping was performed at the last evaluation prior to infusion (see note box above question 101), report “Yes” for question 146 and indicate whether clonal abnormalities were detected in question 147. If karyotyping was not performed at this time point, indicate “No” and go to question 146. Examples of this include: karyotyping was not performed or karyotyping sample was inadequate.

Question 148-151: Specify cytogenetic abnormalities (karyotyping)

Report the International System for Human Cytogenetic Nomenclature (ISCN) compatible string if applicable in question 148, then continue with question 149.

Report the number of abnormalities detected by karyotyping at the last evaluation prior to infusion (see note box above question 101) in question 149. Only consider clonal abnormalities associated with the recipient’s ALL when completing questions 149-151. After indicating the number of abnormalities in question 149, select all abnormalities detected in questions 150-151.

If a clonal abnormality is detected, but not listed as an option in question 150, select “Other abnormality” and specify the abnormality in question 151. If multiple “Other abnormalities” were detected, report “see attachment” in question 151 and attach the final report(s) for any other abnormalities detected. For further instructions on how to attach documents in FormsNet3SM, refer to the Training Guide.

Question 152: Was documentation submitted to the CIBMTR?

Indicate if a karyotyping or FISH testing report is attached to support the cytogenetic findings reported in questions 139-151. For further instructions on how to attach documents in FormsNet3SM, refer to the Training Guide.

Question 153: Were tests for molecular markers performed (e.g., PCR)? (at last evaluation)

See question 115 for a description of testing for molecular markers. If testing for molecular markers was performed at the last evaluation prior to infusion (see note box above question 101), report “Yes” and go to question 154. If molecular marker testing was not performed at this time point or it is not known if testing was done, report “No” or “Unknown” respectively and go to question 158.

Question 154-157: Specify results

For each molecular marker in questions 154-155, report whether testing was “Positive,” “Negative,” or “Not done” at the last evaluation prior to infusion (see note box above question 101). If tests identified a molecular marker other than those listed in questions 154-155, report the result in question 156 and specify the marker in question 157.

If multiple “Other molecular marker[s]” were tested, report one instance (i.e., copy) of question 156-157 for each “Other molecular marker” tested. If greater than 3 “Other molecular marker[s]” were tested, do the following:

  • report one instance of question 154-157; and
  • report “Positive” if any of the “Other molecular marker[s]” were positive, otherwise, report “Negative;” and
  • report “see attachment” in question 157; and
  • attach any / all reports documenting the results of testing for “Other molecular marker[s].”

Question 158: Did the recipient have central nervous system leukemia at any time prior to the start of the preparative regimen / infusion?

Central nervous system (CNS) involvement by leukemia may be detected via pathologic examination of cerebrospinal fluid or tumor tissue as well as by radiological examinations (e.g., MRI, PET/CT, MIBG, etc.). If the recipient had documented involvement of ALL in the CNS, report “Yes” for question 158. If all CNS testing was negative since the time of diagnosis, report “No.” If testing for CNS involvement was not performed from the time of diagnosis to the time of HCT / cellular therapy, report “Unknown.”

Question 159: What was the disease status (based on hematological test results)?

Indicate the disease status of ALL at the last evaluation prior to the start of the preparative regimen. Refer to the ALL Response Criteria section of the Forms Instructions Manual for definitions of each response. For reporting purposes, consider complete remission with incomplete hematologic recovery (CRi) a complete remission (CR1, CR2, or CR3+).

If the recipient did not receive any treatment for ALL from the time of diagnosis to the start of the preparative regimen / infusion, report “No treatment” and go to question 163.

If the recipient’s disease status is primary induction failure at the time of HCT / cellular therapy, go to question 163.

If the recipient’s disease status is CR / CRi at the time of HCT / cellular therapy, go to question 160.

If the recipient’s disease status is relapse at the time of HCT / cellular therapy, go to question 162.

Question 160: How many cycles of induction therapy were required to achieve CR?

Chemotherapy is initially given as induction therapy intended to bring the disease into remission. Recipients usually have one to two cycles of induction therapy. An example of a common induction therapy for precursor B-cell ALL in children with higher-risk prognostic indicators is a combination of vincristine, prednisone, an anthracycline, and L-asparaginase given over 4-6 weeks. Patients with a rapid response, defined as < 5% blasts within 7 to 14 days of starting induction, have improved outcomes.1

1 Gaynon PS, Desai AA, Bostrom BC, et al. Early response to therapy and outcome in childhood acute lymphoblastic leukemia: a review. Cancer. 1997;80(9):1717-26.

The second phase of chemotherapy is known as consolidation therapy. The goal of consolidation therapy is to destroy any remaining leukemia cells and sustain remission. An example of a consolidation therapy for precursor B-cell ALL in children is daunorubicin and cytarabine; several studies support the use of consolidation therapy in ALL.

Maintenance therapy typically involves daily doses of mercaptopurine and weekly doses of methotrexate. Treatment continues for 2-3 years for most children with ALL. Treatment may also be administered for relapsed disease. Much like induction therapy, treatment for relapse is intended to bring the disease back into remission. Systemic therapeutic agents used to induce remission following relapse often differ from those used during initial induction, since the disease is considered high-risk with a poor prognosis and is often resistant to many of the agents used earlier in the disease course. Allogeneic HCT is often considered the only potential “cure” for relapsed disease, if the patient has not already been transplanted.

Indicate the number of cycles of induction therapy that were required to achieve the first CR.

Question 161: Was the recipient in remission by flow cytometry?

Question 161 will only be answered if CR has been reported for question 159. Flow cytometry assessment is a method of analyzing peripheral blood, bone marrow, or tissue preparations for multiple unique cell characteristics. Its primary clinical purpose in the setting of leukemias is to quantify blasts in the peripheral blood or bone marrow, or to identify unique cell populations through immunophenotyping. Flow cytometry assessment may also be referred to as “MRD,” or minimal residual disease, testing.

Flow cytometric remission is a treatment response in which no blasts can be detected.

If flow cytometric abnormalities associated with the recipient’s disease were identified previously, but the criteria above were met at the last evaluation prior to the start of the preparative regimen, indicate “yes.”

If flow cytometric abnormalities associated with the recipient’s disease were identified at the last evaluation prior to the start of the preparative regimen, indicate “no.”

Indicate “unknown” if flow cytometric abnormalities associated with the recipient’s disease were identified previously and no flow cytometry assessment was performed prior to the start of the preparative regimen.

Indicate “not applicable” if one of the following applies:

  • No flow cytometry assessments were performed at any time prior to the start of the preparative regimen.
  • Flow cytometric abnormalities were not identified on previous testing and no flow cytometric abnormalities were identified at the last evaluation prior to the start of the preparative regimen.

Question 162: Date of most recent relapse:

Enter the date of the most recent relapse prior to the start of the preparative regimen. If reporting a pathological evaluation (e.g., bone marrow) or blood/serum assessment (e.g., CBC, peripheral blood smear), enter the date the sample was collected. If extramedullary disease was detected by radiographic examination (e.g., X-ray, CT scan, MRI scan, PET scan), enter the date the imaging took place. If the physician determines cytogenetic or molecular relapse, enter the date the sample was collected for cytogenetic or molecular evaluation. If the physician determines evidence of relapse following a clinical assessment during an office visit, report the date of assessment.

If the exact date is not known, use the process for reporting partial or unknown dates as described in General Instructions, Guidelines for Completing Forms.

Question 163: Date assessed

Enter the date of the most recent assessment of disease status prior to the start of the preparative regimen. The date reported should be that of the most disease-specific assessment within the pre-transplant work-up period (approximately 30 days). Clinical and hematologic assessments include pathological evaluation (e.g., bone marrow biopsy), radiographic examination (e.g., X-ray, CT scan, MRI scan, PET scan), and laboratory assessment (e.g., CBC, peripheral blood smear), in addition to clinician evaluation and physical examination. Enter the date the sample was collected for pathological and laboratory evaluations; enter the date the imaging took place for radiographic assessments.

If the exact date is not known, use the process for reporting partial or unknown dates as described in General Instructions, Guidelines for Completing Forms.

Last modified: Oct 07, 2020

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