Status:
RECRUITING
Bendamustine With or Without Cyclophosphamide in Preventing GVHD in Patients Undergoing Stem Cell Transplant
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Hematopoietic and Lymphoid System Neoplasm
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
PRIMARY OBJECTIVE: I. Evaluate the safety of substituting the standard post-transplant cyclophosphamide (PT-CY) given on day +3 and +4 with post-transplant bendamustine (PT-BEN) in patients undergoin...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04022239
Start Date
March 13 2020
End Date
July 31 2027
Last Update
July 11 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030