RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Post-Transplant Bendamustine (PT-BEN) for GVHD Prophylaxis

Quick Facts

Study Start:2020-03-13
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04022239

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient with hematologic malignancies.
  2. * Donor: Matched sibling, matched unrelated, mismatched or haploidentical
  3. * Zubrod performance 0 to 2 or Karnofsky of at least 60.
  4. * Adequate organ function at time of study entry:
  5. 1. Creatinine less than or equal to 1.6 mg/dL and creatinine clearance \>/= 30 ml/min. Creatinine clearance will be calculated using the Cockcroft-Gault equation
  6. 2. Total bilirubin less than \< 1.5 x UNL
  7. 3. SGPT \< 2.5 x ULN
  8. 4. Ejection fraction \>/= 40%
  9. 5. FEV1, FVC and DLCO \>/= 40%
  10. * Female patients of childbearing potential must agree to use an effective method of birth control while on study and for 6 months after the last dose of bendamustine. Male patients with female partners of childbearing potential must agree to use an effective method of birth control while on study and for 3 months after the last dose of bendamustine.
  1. * Pregnant or nursing women.
  2. * Known to be HIV positive
  3. * Active and uncontrolled disease/infection
  4. * Unable or unwilling to sign consent
  5. * Current active hepatic or biliary disease (with exception of Gilbert's syndrome)
  6. * Active hepatitis B or C.
  7. * Toxicities (grade \> 1) unresolved from prior treatment (including chemotherapy, targeted therapy, immunotherapy, experimental agents radiation, or surgery.
  8. * Patients with standard risk acute leukemia in first complete remission and patients with chronic myeloid leukemia in first chronic will be excluded during escalated phase.

Contacts and Locations

Study Contact

Issa F. Khouri, M D
CONTACT
713-745-0049
ikhouri@mdanderson.org

Principal Investigator

Issa F Khouri
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Issa F Khouri, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-03-13
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2020-03-13
Study Completion Date2025-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Hematopoietic and Lymphoid System Neoplasm