Reduced-intensity, Related-donor Bone Marrow Transplantation Followed by High-dose Cyclophosphamide for Hematologic Cancers
|ClinicalTrials.gov Identifier: NCT01135329|
Recruitment Status : Terminated (The stopping rule was met and hence the study was closed)
First Posted : June 2, 2010
Last Update Posted : April 17, 2014
This research is being done to learn more about reduced-intensity bone marrow transplantation (BMT), also known as a "mini" transplant for patients with blood cancers, using bone marrow from a relative.
The main goal of the study is to determine how quickly the donor's bone marrow "takes" in your body. Other goals include describing how many people accept the bone marrow and how quickly the blood counts come up; describing Graft-versus-host disease (GVHD) and other complications; and describing how many people survive without progressive cancer and survive overall
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Leukemia Myelodysplastic Syndrome||Drug: Fludarabine, Busulfan, Cyclophosphamide, Tacrolimus,||Phase 2|
At the present time there are few or no cures for people with cancer of the blood or lymph glands outside of a bone marrow transplant (BMT). BMT has developed over several decades of research as an effective treatment of various malignant and nonmalignant hematologic diseases.
This research is being done to learn more about reduced-intensity bone marrow transplantation (BMT), also known as a "mini" transplant for patients with blood cancers, using bone marrow from a relative. The bone marrow for this transplant comes from a relative who is a half-match or "haplo" match to you. Possible donors include parents, siblings, and children.
"Mini" transplants have been given to many people with various cancers but are considered experimental. Over 200 people at Johns Hopkins have received mini transplants with high doses of cyclophosphamide after the transplant. However, the chemotherapy combination and other treatment given before those transplants were different from what is in this study. Although all of the chemotherapy and immune-lowering drugs used in this study are approved by the Food and Drug Administration (FDA), the combination of medications used in this study are not FDA approved and are experimental.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reduced-intensity, Related-donor Allogeneic BMT With Fludarabine, Busulfan, and High-dose Posttransplantation Cyclophosphamide for Hematologic Malignancies|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
- Drug: Fludarabine, Busulfan, Cyclophosphamide, Tacrolimus,
Fludarabine 30 mg/m2 IV once a day for 4 days Busulfan 0.8 mg/kg IV every 12 hours for 4 days Cyclophosphamide 50 mg/kg IV daily for 2 daysOther Names:
- Estimate the proportion of patients achieving full donor chimerism [ Time Frame: Day 60 ]After reduced-intensity, partially (Human leukocyte antigen) HLA-mismatched or HLA-matched BMT with fludarabine, busulfan, and post-grafting immunosuppression that includes high-dose cyclophosphamide, estimate the proportion achieving full donor chimerism by Day 60 in unsorted and CD3+ sorted peripheral blood.
- Graft-versus-host disease (GVHD) [ Time Frame: Day 60 ]Estimate the cumulative incidence of acute and chronic Graft-versus-host disease (GVHD), and describe other major toxicities.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01135329
|United States, Maryland|
|The Sydney Kimmel Comprehensive Cancer Center|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator:||Yvette Kasamon, M.D.||Johns Hopkins University|