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Bendamustine With or Without Cyclophosphamide in Preventing GVHD in Patients Undergoing Stem Cell Transplant

NCT04022239 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-01-12

No results posted yet for this study

Summary

This phase I/II trial studies the side effects and best dose of bendamustine when given with or without cyclophosphamide in preventing graft versus host disease (GVHD) in patients undergoing stem cell transplant. Drugs used in chemotherapy, such as bendamustine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy and total body irradiation before or after a stem cell transplant helps kills cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Sometimes, the transplanted cells from a donor can attack the body's normal cells called GVHD. Giving tacrolimus, mycophenolate mofetil, and filgrastim after the transplant may stop this from happening.

Conditions

  • Hematopoietic and Lymphoid System Neoplasm

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo stem cell transplantation

DRUG

Bendamustine

Given IV

DRUG

Cyclophosphamide

Given IV

BIOLOGICAL

Filgrastim-sndz

Given SC

DRUG

Fludarabine

Given IV

DRUG

Melphalan

Given IV

DRUG

Mycophenolate Mofetil

Given PO

BIOLOGICAL

Rituximab

Given IV

DRUG

Tacrolimus

Given IV and PO

RADIATION

Total-Body Irradiation

Undergo TBI

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

Principal Investigators

  • Issa F Khouri · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-03-13
Primary Completion
2027-07-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04022239 on ClinicalTrials.gov