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Donor Matching Strategies for Blood Cancer Transplants (BMT CTN 1702 Trial)
N/A
Waitlist Available
Research Sponsored by Center for International Blood and Marrow Transplant Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient and physician must intend to proceed with allogeneic HCT within the next 6 months if a suitable donor is identified
Signed informed consent, and assent if applicable. Consent may be signed prior to completion of family typing but patients will only be considered evaluable upon confirmation that there is no suitable HLA-identical or 1 allele or antigen mismatched related donor available
Must not have
Prior allogeneic HCT (prior autologous transplant is allowed)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare two ways of finding a donor for a person with blood cancer who needs a transplant.
Who is the study for?
This trial is for patients with conditions like various leukemias, lymphomas, sickle cell disease, and aplastic anemia who need a stem cell transplant but don't have a closely matched family donor. They should be fit for transplantation based on their medical history and tests. Patients already having had an allogeneic transplant can't join.
What is being tested?
The study aims to see if searching for a fully matched unrelated donor before considering alternative donors leads to better survival within two years after joining the study compared to going straight to an alternative donor transplant.
What are the potential side effects?
While specific side effects are not listed here, allogeneic transplants typically carry risks such as graft-versus-host disease (where the new cells attack your body), infections due to weakened immune system, organ damage, and reactions from the conditioning regimen.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I plan to have a stem cell transplant from a donor within 6 months if we find a match.
Select...
I have signed the consent form and understand the study.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had a transplant from another person.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Survival for MUD Very Likely and MUD Very Unlikely Arms
Secondary study objectives
Barriers to Transplant
Cumulative Incidence of Transplant by Donor Search Prognosis Score
Other study objectives
AML or ALL in first complete remission or early stage MDS Substudy - CRFS
Muscular Dystrophy
AML or ALL in first complete remission or early stage MDS Substudy - QoL
+15 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Donor Search Prognosis: MUD Very UnlikelyExperimental Treatment1 Intervention
Patients who are Very Unlikely to find a MUD, defined as having a \<10% chance of finding an 8/8 HLA-matched unrelated donor, for whom a haploidentical, cord blood, or mismatched unrelated donor transplant will be pursued.
Group II: Donor Search Prognosis: MUD Very LikelyExperimental Treatment1 Intervention
Patients who are Very Likely to find a matched unrelated donor (MUD), defined as having a \>90% chance of finding an 8/8 HLA-matched unrelated donor, for whom a fully matched unrelated donor will be pursued.
Group III: Donor Search Prognosis: MUD Less LikelyExperimental Treatment1 Intervention
Patients with a Less Likely chance of finding a MUD, i.e., those not falling into the other two groups (a 26% chance), will be enrolled onto the observational component of the study and analyzed for all relevant endpoints but will not be included in the primary comparison.
Find a Location
Who is running the clinical trial?
National Marrow Donor ProgramOTHER
61 Previous Clinical Trials
200,873 Total Patients Enrolled
Medical College of WisconsinOTHER
633 Previous Clinical Trials
1,179,942 Total Patients Enrolled
Blood and Marrow Transplant Clinical Trials NetworkNETWORK
50 Previous Clinical Trials
12,801 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,021,417 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,938 Previous Clinical Trials
47,790,545 Total Patients Enrolled
Center for International Blood and Marrow Transplant ResearchLead Sponsor
38 Previous Clinical Trials
200,191,677 Total Patients Enrolled
Stephanie J Lee, MD, MPHStudy ChairFred Hutchinson Cancer Center
Stefan Ciurea, MDStudy ChairM.D. Anderson Cancer Center
2 Previous Clinical Trials
187 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a family member who could be a donor but is deemed unsuitable by the medical center.I am deemed fit for a transplant from another person based on my health records and tests.I have not had a transplant from another person.My doctor will decide if I'm fit for a transplant based on my organ function tests, if available.I plan to have a stem cell transplant from a donor within 6 months if we find a match.I have signed the consent form and understand the study.I don't have a closely matched family donor for a transplant.My treatment plan includes any type of preparation and graft-versus-host disease prevention.I have been diagnosed with AML, ALL, MDS, NHL, HL, AA, or SCD.
Research Study Groups:
This trial has the following groups:- Group 1: Donor Search Prognosis: MUD Very Unlikely
- Group 2: Donor Search Prognosis: MUD Very Likely
- Group 3: Donor Search Prognosis: MUD Less Likely
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.