Family-mismatched/Haploidentical Donors Versus Matched Unrelated Donors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01751997|
Recruitment Status : Recruiting
First Posted : December 18, 2012
Last Update Posted : April 20, 2018
This study will compare the clinical outcomes of transplants from family-mismatched/haploidentical donors (FMT) with transplants from 8/8-matched unrelated donor (MUT), which is a current gold standard donors when lacking of HLA-matched-siblings
- Primary objectives: Overall survival of FMT may be similar to that of MUT
i. Comparison of disease-free survival, relapse, non-relapse mortality, immune reconstitution cytomegalovirus infection, and acute or chronic graft-versus-host disease between FMT and MUT.
ii. Investigation of possible biomarkers related with above events after transplantation
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: Transplants from 8/8-matched Unrelated donors Drug: Transplants from family-mismatched/haploidentical donors||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Comparison of Transplantation From Family-mismatched/Haploidentical Donors With Matched Unrelated Donors in Adult Patients With Acute Myeloid Leukemia|
|Actual Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
Active Comparator: Transplants from 8/8-matched unrelated
Participants will receive transplants from 8/8-matched unrelated donors using myeloablative or reduced-intensity conditioning according to age or comorbidity.
Drug: Transplants from 8/8-matched Unrelated donors
Experimental: Transplants from family-mismatched/haploidentical donors
Participants will receive FMT using a reduced intensity conditioning regimens.
Drug: Transplants from family-mismatched/haploidentical donors
- Overall survival [ Time Frame: annually through 3 years ]Overall survival is defined as the time interval between date of enrollment and death from any cause or for surviving patients, to last follow-up
- Neutrophil recovery [ Time Frame: 56 days ]defined as achieving an absolute neutrophil count greater than or equal to 500/mm^3 for three consecutive measurements on three difference days. The first of the 3 days will be designated the day of neutrophil recovery.
- Primary Graft failure [ Time Frame: 56 days ]defined as failure to achieve a neutrophil count greater than 500/mm^3 for 3 consecutive days at any time after transplantation.
- Secondary Graft failure [ Time Frame: 100 days ]defined as the development of an absolute neutrophil count less than 500/mm^3 after achievement of initial engraftment in the absence of recurrent disease.
- Platelet recovery [ Time Frame: 100 days and 180 days ]defined as the first day of a sustained platelet count greater than 20,000/mm^3 without platelet transfusions in preceding 7 days. The first day of the sustained platelet count will be designated the day of platelet engraftment.
- Donor cell engraftment [ Time Frame: 56 days ]Donor cell engraftment is defined as donor chimerism greater than or equal 5% on Day 56 after transplantation. Chimerism may be evaluated in whole blood or blood cell fractions, including cluster of differentiation (CD) 3 and CD33 or CD15 fractions. The actual measurement dates may be within +/- 7 days of the above recommended time points.
- Acute graft-versus-host disease (aGVHD) [ Time Frame: every 3 months through 3 years ]The cumulative incidence of aGVHD (grade II-IV and III-IV) will be determined. The time to onset of aGVHD will be recorded, as well as the maximum grade achieved.
- Chronic graft-versus-host disease (cGVHD) [ Time Frame: every 3 months through 3 years ]The cumulative incidence of cGVHD will be determined. Data will be collected directly from providers and chart review according to the recommendations of the NIH Consensus Conference. The NIH global severity scores of mild, moderate, and severe cGVHD will be assessed.
- Disease free survival [ Time Frame: annually through year 3 ]defined as the time interval from date of enrollment and time to relapse/progression, to death or to last follow-up
- Non-relapse mortality [ Time Frame: annually through year 3 ]The cumulative incidence of non-relapse mortality will be estimated at Days 100, 180, and at 1 and 2 years after transplantation. An event for this endpoint is death without evidence of disease progression or recurrence
- Infection [ Time Frame: annually through year 3 ]All grade 2 and 3 infections will be reported. Grade 1 cytomegalovirus infections through Day 56 will also be reported.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751997
|Contact: Hee-Je Kim, MD, PhDfirstname.lastname@example.org|
|Contact: Byung-Sik Cho, MD, PhDemail@example.com|
|Korea, Republic of|
|Catholic Blood and Marrow Transplantation Center, Seoul St. Mary's Hospital||Recruiting|
|Seoul, Korea, Republic of, 137-701|
|Principal Investigator:||Hee-Je Kim, MD, PhD||Catholic Blood and Marrow Transplantation Center, Seoul St. Mary's Hospital, The Catholic University of Korea|