What this study is
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.
What's being tested
- Allogeneic Hematopoietic Stem Cell Transplantation
Intervention · PROCEDURE
Undergo stem cell transplantation
- Bendamustine
Intervention · DRUG
- Cyclophosphamide
Intervention · DRUG
- Filgrastim-sndz
Intervention · BIOLOGICAL
Given SC
- Fludarabine
Intervention · DRUG
- Melphalan
Intervention · DRUG
- Mycophenolate Mofetil
Intervention · DRUG
Given PO
- Rituximab
Intervention · BIOLOGICAL
- Tacrolimus
Intervention · DRUG
Given IV and PO
- Total-Body Irradiation
Intervention · RADIATION
Undergo TBI
All of Bendamustine, Cyclophosphamide, Fludarabine, Melphalan, Rituximab
Given IV
Study details
- Official title
- Post-Transplant Bendamustine (PT-BEN) for GVHD Prophylaxis
- Sponsor
- M.D. Anderson Cancer Center
- Conditions
- Hematopoietic and Lymphoid System Neoplasm
- Enrolling
- 25 people
- Starts
- 2020-03-13
- Est. completion
- 2027-07-31
- Design
- Open-label, non-randomized, parallel groups, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 70 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Patient with hematologic malignancies.
- Donor: Matched sibling, matched unrelated, mismatched or haploidentical
- Zubrod performance 0 to 2 or Karnofsky of at least 60.
- Adequate organ function at time of study entry:; 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; Total bilirubin less than < 1.5 x UNL; SGPT < 2.5 x ULN; Ejection fraction >/= 40%; FEV1, FVC and DLCO >/= 40%
- 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.
You can't join if
- Pregnant or nursing women.
- Known to be HIV positive
- Active and uncontrolled disease/infection
- Unable or unwilling to sign consent
- Current active hepatic or biliary disease (with exception of Gilbert's syndrome)
- Active hepatitis B or C.
- Toxicities (grade > 1) unresolved from prior treatment (including chemotherapy, targeted therapy, immunotherapy, experimental agents radiation, or surgery.
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openM D Anderson Cancer Center
Houston, Texas, United States
- Issa F. Khouri · Contact713-745-0049ikhouri@mdanderson.org
- Issa F. Khouri · Principal investigator
Recruiting
Study team
Sponsor
M.D. Anderson Cancer Center
Study ID 2018-0972
Principal investigator
Issa F Khouri
M.D. Anderson Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.