Reduced-intensity, Related-donor Bone Marrow Transplantation Followed by High-dose Cyclophosphamide for Hematologic Cancers
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|ClinicalTrials.gov Identifier: NCT01135329|
Recruitment Status : Terminated (The stopping rule was met and hence the study was closed)
First Posted : June 2, 2010
Results First Posted : July 3, 2018
Last Update Posted : July 3, 2018
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 Drug: Busulfan Drug: Cyclophosphamide Drug: Mycophenolate Mofetil Drug: 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|
Reduced-intensity transplant with a fludarabine- and busulfan-based preparative regimen. GVHD prophylaxis with cyclophosphamide, tacrolimus, and mycophenolate mofetil.
30 mg/m^2 IV daily on Day -6 through Day -2.
1 mg/kg PO OR 0.8 mg/kg IV four times daily on Day -6 through Day -3.
50 mg/kg IV daily on Day +3 and Day +4.
Drug: Mycophenolate Mofetil
15 mg/kg PO three times daily (max daily dose of 3g) starting on Day +5.
Dosed based on drug levels; begin on Day +5 at 1 mg IV daily.
- Chimerism in Unsorted Peripheral Blood [ Time Frame: Day 60 ]Percentage of participants achieving full-donor chimerism in unsorted peripheral blood.
- Chimerism in CD3+ Sorted Peripheral Blood [ Time Frame: Day 60 ]Percentage of participants achieving full-donor chimerism in CD3+ sorted peripheral blood
- Overall Survival [ Time Frame: 1 year ]Percentage of participants alive
- Progression-free Survival [ Time Frame: 1 year ]Percentage of participants alive without disease relapse or progression.
- Incidence of Relapse [ Time Frame: 1 year ]Percentage of participants experiencing disease relapse or progression
- Non-relapse Mortality [ Time Frame: 1 year ]Percentage of participants who died due to BMT-related reasons
- Incidence of Graft-versus-host-disease (GVHD) [ Time Frame: 1 year ]Percentage of participants experiencing acute and chronic GVHD. Acute GVHD is graded by Przepiorka criteria. Chronic GVHD is graded by NIH consensus criteria and Seattle criteria.
- Graft Failure [ Time Frame: Day 60 ]Percentage of participants who failed to engraft.
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): NCT01135329
|United States, Maryland|
|The Sydney Kimmel Comprehensive Cancer Center|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator:||Yvette Kasamon, M.D.||Johns Hopkins University|