Donor Stem Cell Transplant Followed by Cyclophosphamide in Treating Patients With Hematological Diseases

NCT02248597 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-10-11

Study results available
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Summary

This pilot clinical trial studies donor stem cell transplant followed by cyclophosphamide in treating patients with hematological diseases. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving cyclophosphamide after the transplant may stop this from happening.

Conditions

Interventions

DRUG

fludarabine phosphate

Given IV

DRUG

busulfan

Given IV

DRUG

cyclophosphamide

Given IV

PROCEDURE

allogeneic hematopoietic stem cell transplantation

Undergo myeloablative or reduced intensity allogeneic stem cell transplant

DRUG

tacrolimus

DRUG

mycophenolate mofetil

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Dianna S. Howard · Wake Forest University Health Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-25
Primary Completion
2022-01-18
Completion
2023-01-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT02248597 on ClinicalTrials.gov