MedTrace Logo

A Research Study of Bone Marrow Transplantation From Unrelated or Partially Matched Related Donors

NCT01349101 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-12-15

Study results available
· View outcomes & findings →

Summary

It is hypothesized that engraftment when administering cyclophosphamide post the stem cell infusion will increase, the incidence of graft versus host disease (GVHD) and day 100 mortality will decrease, and the use of cyclophosphamide post stem cell infusion with alternative donors will be as safe and as effective as traditional matched transplants.

Conditions

Interventions

GENETIC

Hematopoietic stem cell transplantation

Allogeneic marrow transplantation given after the last dose of total body irradiation (TBI)

DRUG

Cyclophosphamide

Cyclophosphamide is administered on the third day after the hematopoietic stem cell transplantation (HSCT) to help reduce graft-versus-host disease (GVHD). It is given at a dose of 60 mg/kg/d for 2 days on days +3 and +4.

DRUG

Tacrolimus

Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).

DRUG

Mycophenolate mofetil

Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).

DRUG

Fludarabine

Started the fifth day before the transplant. Given for four days at 30 mg/m2/d.

DRUG

Busulfan

Started the fourth day before the transplant. Given for two days at 3.2 mg/kg.

RADIATION

Total Body Irradiation

Myeloablative HSCT Arm: Total body irradiation (TBI) is given in 8 fractions over 4 days (total dose of 12 Gy) Reduced Intensity HSCT Arm: TBI is given in one fraction (total dose of 2 Gy)

Sponsors & Collaborators

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    lead OTHER

Principal Investigators

  • John L Wagner, MD · Thomas Jefferson University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-10
Primary Completion
2022-10-31
Completion
2022-12-07

Countries

  • United States

Study Locations

More Related Trials

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 NCT01349101 on ClinicalTrials.gov