Question 1: Date of diagnosis of primary disease for HCT / cellular therapy

Report the date of the first pathological diagnosis (e.g., bone marrow or tissue biopsy) of the disease. Enter the date the sample was collected for examination. If the diagnosis was determined at an outside center, and no documentation of a pathological or laboratory assessment is available, the dictated date of diagnosis within a physician note may be reported. Do not report the date symptoms first appeared.

If the exact diagnosis date is not known, use the process described in General Instructions, Guidelines for Completing Forms

Questions 180 – 181: Specify acute leukemias of ambiguous lineage and other myeloid neoplasm classification

Indicate the other acute leukemia disease classification at diagnosis. If the subtype is not listed, report as* Other acute leukemia of ambiguous lineage or myeloid neoplasm* and specify the reported disease.

  • Acute undifferentiated leukemia is a type of AML characterized by immature predominating cells that cannot be classified.
  • Biphenotypic, bilineage, or hybrid leukemias have characteristics representative of both myeloid and lymphoid lineages.
  • Mast cell leukemia is characterized by an increased number of tissue mast cells in the peripheral blood.

Question 182: What was the disease status (based on hematological test results)?

Indicate the disease status of acute leukemia at the last evaluation prior to the start of the preparative regimen.

Table 7. Disease Status of Acute Leukemia

Disease Status Definition
Primary Induction Failure (PIF) The patient received treatment for acute leukemia but never achieved complete remission at any time. PIF is not limited by the number of unsuccessful treatments; this disease status only applies to recipients who have never been in complete remission.
Complete Remission (CR) Hematologic complete remission is defined as meeting all of the following response criteria for at least four weeks.
  • < 5% blasts in the bone marrow
  • Normal maturation of all cellular components in the bone marrow
  • No extramedullary disease (e.g., CNS, soft tissue disease)
  • Neutrophils ≥ 1,000/µL
  • Platelets ≥ 100,000/µL
  • Transfusion independent
    In some cases, there may not be a four-week interval between completion of therapy and the pre-transplant disease assessment; in this case, CR should still be reported as the status at transplant, since it represents the “best assessment” prior to HCT. This is an exception to the criteria that CR be durable beyond four weeks; the pre-transplant disease status should not be changed based on early relapse or disease assessment post-transplant.
    Include recipients with persistent cytogenetic or molecular abnormalities who meet the above CR criteria for hematologic CR.
    Include recipients meeting the above CR criteria regardless of how many courses of therapy were required to achieve CR.
    The number of this complete remission can be determined by using the following guidelines:
  • 1st CR: no prior relapse
  • 2nd CR: one prior relapse
  • 3rd or higher: two or more prior relapses
Relapse (REL) Relapse is defined as the recurrence of disease after CR, meeting the following criteria:
  • ≥ 5% blasts in the marrow or peripheral blood
  • Extramedullary disease
  • Reappearance of cytogenetic and/or molecular abnormalities associated with diagnosis that, in the judgment of a physician, are at a level representing relapse
  • Disease presence determined by a physician upon clinical assessment
    The number of this relapse can be determined by using the following guidelines:
  • 1st relapse: one prior CR
  • 2nd relapse: two prior CRs
  • 3rd or higher: three or more CRs
    Do not include a partial response (PR) when determining number of relapse. Recipients who achieve a PR to treatment should be classified as either PIF or relapse; PR in acute leukemia is generally of short duration and is unlikely to predict clinical benefit.
No Treatment The recipient was diagnosed with acute leukemia and never received therapeutic agents; include patients who have received only supportive therapy, including growth factors and/or blood transfusions.

Question 183: 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.

Section Updates:

Question Number Date of Change Add/Remove/Modify Description Reasoning (If applicable)
. . . . .
Last modified: Sep 23, 2022

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