NCT04022239 Bendamustine With or Without Cyclophosphamide in Preventing GVHD in Patients Undergoing Stem Cell Transplant
| NCT ID | NCT04022239 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Hematopoietic and Lymphoid System Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2020-03-13 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 25 participants in total. It began in 2020-03-13 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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.
Contact & Investigator
Issa F Khouri
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT04022239 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Hematopoietic and Lymphoid System Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04022239 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04022239 currently recruiting?
Yes, NCT04022239 is actively recruiting participants. Contact the research team at ikhouri@mdanderson.org for enrollment information.
Where is the NCT04022239 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT04022239 clinical trial?
NCT04022239 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Issa F Khouri at M.D. Anderson Cancer Center. The trial plans to enroll 25 participants.