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Reduced Intensity, Partially HLA Mismatched BMT to Treat Hematologic Malignancies

NCT01203722 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2026-02-19

Study results available
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Summary

If transplantation using mismatched unrelated donors or non-first-degree relatives could be performed with an acceptable toxicity profile, an important unmet need would be served. Towards this goal, the current study extends our platform of nonmyeloablative, partially HLA-mismatched bone marrow transplant (BMT) and Peripheral Blood Stem Cell Transplant (PBSCT) to the use of such donors, investigating up to several postgrafting immunosuppression regimens that incorporate high-dose Cy. Of central interest is the incorporation of sirolimus into this postgrafting immunosuppression regimen.

The primary goal for phase 1 is to identify a transplant regimen associated with acceptable rates of severe acute GVHD and NRM by Day 100 and for phase 2 estimate the 6-month probability of survival without having had acute grade III- IV GVHD or graft failure.

Conditions

Interventions

DRUG

Fludarabine

Fludarabine 30 mg/m2/day

DRUG

Cytoxan

Pre-BMT: Cytoxan 14.5 mg/kg/day administered IV; Post-Transplantation: High-dose Cytoxan 50mg/kg/day

RADIATION

Total Body Irradiation

400 cGy TBI administered in a single fraction

PROCEDURE

Allogeneic Blood or Marrow Transplant

PROCEDURE

Peripheral Blood Stem Cell Transplant

DRUG

Mycophenolate Mofetil

15mg/kg by mouth three times daily

DRUG

Sirolimus

Loading Dose: Sirolimus 6mg by mouth once; Maintenance dose: Sirolimus 2mg by mouth daily

DRUG

Tacrolimus

Tacrolimus 1mg intravenously, daily

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Richard Ambinder, MD · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2024-05-28
Completion
2024-05-28
FDA Drug
Yes

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 NCT01203722 on ClinicalTrials.gov