A Randomized study of Combined Haplo-identical Umbilical Cord Transplantation vs. Double Umbilical Cord Transplantation in Patients with Hematologic Malignancies
Study Status
Open to Enrollment
Study Description
This is a clinical trial for patients with hematologic malignancies (like leukemia, lymphoma, or myelodysplastic syndrome) who are in need of a donor stem cell transplant, and for whom an umbilical cord blood transplant is thought to be the best option. Typically these are patients for whom a sibling donor or a matched unrelated donor is not available.
This study tests a new method of bone marrow transplantation called combined haplo-identical cord (haplo-cord) transplantation. In this procedure, cells from a partially matched related donor are collected from the blood, as well as cells from an umbilical cord, and then transplanted. It is hoped that by using cells from a relative, subjects will have a faster recovery and require fewer transfusions. The combined transplantation of haplo-identical stem cells and cord blood has previously been used in approximately 60 patients with very encouraging results.
The purpose of this study is to compare the efficacy of haplo-cord transplant (the “experimental arm”) with the more commonly used procedure in which only the cells contained in one or two umbilical cords are infused (the “standard arm”). Patients will be randomly assigned into either the haplo-cord group or the umbilical cord group. Neither you nor the study physicians will choose which group you are assigned to.
If you are randomized to the haplo-cord group, your family member will undergo a stem cell collection.
In both arms, patients will receive a “conditioning regimen” prior to transplantation. The conditioning regimen consists of chemotherapy, which is meant to destroy the cancer cells and suppress the immune system to allow the transplanted cells to grow.
Patients will remain in the hospital until the stem cells are fully recovered, which is usually 4 to 6 weeks after the transplant. Patients will have bone marrow aspiration and biopsy at 3 weeks, 4 weeks, 2 months, 6 months and 1 year after the transplant and then yearly thereafter. Participation in the study will continue for up to 5 years after transplantation.
Disease Status and/or Stage
Hematologic Malignancies in Need of Donor Stem Cell Transplant
Sponsor
Weill Cornell Medical College
Key Eligibility
- Men and women age 18 or older
- Diagnosed with:
- Acute Myelogenous Leukemia
- Myelodysplastic Syndrome
- Acute Lymphocytic Leukemia
- Lymphoma (Hodgkin or non-Hodgkin)
- Likely to benefit from allogeneic transplant
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- June Greenberg, RN
- (212) 746-2651
- [email protected]
- Bone Marrow Transplant Medical Practice
- (212) 746-2119
Healthy Volunteers
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]
