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

NCT01135329 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-07-03

Study results available
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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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Yvette Kasamon, M.D. · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01135329 on ClinicalTrials.gov