NCT01135329

Reduced-intensity, Related-donor Bone Marrow Transplantation Followed by High-dose Cyclophosphamide for Hematologic Cancers

Reduced-intensity, Related-donor Allogeneic BMT With Fludarabine, Busulfan, and High-dose Posttransplantation Cyclophosphamide for Hematologic Malignancies

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 6 Months – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Lymphoma
• Leukemia
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Fludarabine	30 mg/m\^2 IV daily on Day -6 through Day -2.
DRUG	Busulfan	1 mg/kg PO OR 0.8 mg/kg IV four times daily on Day -6 through Day -3.
DRUG	Cyclophosphamide	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.
DRUG	Tacrolimus	Dosed based on drug levels; begin on Day +5 at 1 mg IV daily.

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2010-06-02
• Last updated: 2018-07-03
• Results posted: 2018-07-03

Locations

1 site across 1 country: United States