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

Launched by M.D. ANDERSON CANCER CENTER · Jul 15, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two chemotherapy drugs, bendamustine and cyclophosphamide, to see if they can help prevent a condition called graft versus host disease (GVHD) in patients who are undergoing a stem cell transplant. GVHD can occur when the donor's cells attack the recipient's healthy cells after the transplant. The trial aims to find the right dosage of bendamustine and understand its side effects when used alone or with cyclophosphamide.

To participate in this trial, patients should be between the ages of 18 and 75 and have certain types of blood cancers. They must also meet specific health criteria, such as having good kidney and liver function. Participants can expect to receive treatment and monitoring to assess how well the drugs work and any side effects they may experience. It's important to note that not everyone will qualify for the trial, especially those with certain health issues or who are pregnant.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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:
• • 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
• • 2. Total bilirubin less than \< 1.5 x UNL
• • 3. SGPT \< 2.5 x ULN
• • 4. Ejection fraction \>/= 40%
• • 5. 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 Criteria:
• • 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.