Clinical Trials
Resource for Clinical Investigation
in Blood and Marrow Transplantation (RCI BMT)
Purpose
Well planned and coordinated multi-center phase I and II studies are critical for advancing the field of hematopoietic cell transplantation. To facilitate such studies, the CIBMTR has formed the Resource for Clinical Investigation in Blood and Marrow Transplantation (RCI BMT) to provide statistical expertise and data management services for multi-center phase I/II trials. While not a funding agency, the CIBMTR, through the RCI BMT, will partner with investigators to obtain necessary support for trial completion.
Types of Studies
The goal of the RCI BMT is to bridge the gap between single-center studies and the larger phase II and phase III studies conducted by the Blood and Marrow Transplant Clinical Trials Network (BMT CTN), also coordinated by the CIBMTR in collaboration with the National Marrow Donor Program and the EMMES Corporation. In general, RCI BMT studies should meet the following criteria:
- Require 10 or fewer centers
- Require 50 or fewer patients
- Have some pilot data available or a plan with which to obtain those data prior to initiating the trial
- conditioning regimens
- different stem cell sources
- non-interventional transplant-focused trials (e.g. interview studies of long-term survivors)
- novel means of preventing or treating post-transplant complications including relapse of the primary disease
Proposal Submission
Proposals may be submitted at any time and should utilize the designated template. Investigators are encouraged to identify potential participating centers prior to proposal submission. The CIBMTR will use the registry database to assess feasibility and possible need for additional centers
Procedure for Review and Implementation
Upon receipt of the proposal, a preliminary review will be done by CIBMTR Statistical Center staff and appropriate Working Committee chairs to evaluate potential numbers of patients, competing studies, and scientific interest. Acceptable proposals will be referred to the CIBMTR Clinical Trials Advisory Committee (CTAC) for formal scientific review. CTAC review will occur three times per year - at the Tandem BMT meeting, a summer meeting, and a fall meeting. All proposals to be discussed at CTAC should be received 1 month in advance of that meeting. These submission deadlines will be posted on the CIBMTR website. The RCI BMT Executive Committee will determine final priority for studies based on scientific merit, funding, and staffing issues. At that time, a protocol team will be identified and a timeline for protocol development outlined.
Funding
The proposal should outline existing and potential sources of financial support for the trial, though full commitment of financial support is not a requirement. The CIBMTR, in some circumstances, may be able to assist in securing funds for trial completion or to partner in grant applications for financial support.
RCI BMT Clinical Trials
| Study ID | Study Status | Study Contact | Study Summary |
|---|---|---|---|
| 05 DCB-Double Cord Blood | Enrolling* | Amy Foley | Synopsis |
| 06 DON-Donor Safety | In Development | Kathleen Delaney | Synopsis |
| 07-REV | Enrolling* | Colleen DeSutter | Synopsis |
Access to study materials and the data entry system:
https://web.emmes.com/study/rcibmt
Study Contact Information:
Email (cibmtr_rci_bmt@nmdp.org)
Amy Foley, Sr. Clinical Research Specialist, 612-884-8605
Colleen DeSutter, Sr. Clinical Research Specialist, 612-884-8604
Kathleen Delaney, Sr. Clinical Research Specialist, 612-884-8631
Janel Clemons, Clinical Research Specialist, 612-884-8610
Jennifer Oakes, Clinical Research Specialist, 612-884-8619
Marina Ostanniy, Clinical Research Assistant, 612-884-8606
Questions and Contacts
The Resource for Clinical Investigation in Blood and Marrow Transplantation is based at the Minneapolis campus of the CIBMTR. For further questions, please contact or email (cibmtr_rci_bmt@nmdp.org) either Marcie Tomblyn, MD, MS (612-624-5109) or Becky Drexler (612-884-8600).