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
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
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.
The Sydney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Chimerism in Unsorted Peripheral Blood
Percentage of participants achieving full-donor chimerism in unsorted peripheral blood.
Time frame: Day 60
Chimerism in CD3+ Sorted Peripheral Blood
Percentage of participants achieving full-donor chimerism in CD3+ sorted peripheral blood
Time frame: Day 60
Overall Survival
Percentage of participants alive
Time frame: 1 year
Progression-free Survival
Percentage of participants alive without disease relapse or progression.
Time frame: 1 year
Incidence of Relapse
Percentage of participants experiencing disease relapse or progression
Time frame: 1 year
Non-relapse Mortality
Percentage of participants who died due to BMT-related reasons
Time frame: 1 year
Incidence of Graft-versus-host-disease (GVHD)
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.
Time frame: 1 year
Graft Failure
Percentage of participants who failed to engraft.
Time frame: Day 60
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