Clinical trial · Interventional
Bendamustine With or Without Cyclophosphamide in Preventing GVHD in Patients Undergoing Stem Cell Transplant
Post-Transplant Bendamustine (PT-BEN) for GVHD Prophylaxis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic and Lymphoid System Neoplasm | Hematopoietic and Lymphatic System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic Hematopoietic Stem Cell Transplantation | Procedure | — | UNRESOLVED |
| Bendamustine | Drug | Bendamustine | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Filgrastim-sndz | Biological | Filgrastim | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Mycophenolate Mofetil | Drug | — | UNRESOLVED |
| Rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Schedule I (non-lymphoma)
- description
- Patients receive fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on days -5 and -4, and undergo TBI on day -1 and stem cell transplantation IV over 2-6 hours on day 0. Depending on when the trial was joined, patients receive cyclophosphamide IV over 3 hours or bendamustine IV over 30-60 minutes or cyclophosphamide IV over 3 hours and bendamustine IV over 30-60 minutes on day 3. Patients also receive bendamustine IV over 30-60 minutes on day 4. Beginning day 5, patients receive tacrolimus IV followed by PO QD or BID for 6 months and mycophenolate mofetil PO TID until day 100. Beginning day 7, patients receive filgrastim-sndz SC QD until blood cell levels return to normal.
- interventionNames
- Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
- Drug: Bendamustine
- Drug: Cyclophosphamide
- Biological: Filgrastim-sndz
- Drug: Fludarabine
- Drug: Melphalan
- Drug: Mycophenolate Mofetil
- Drug: Tacrolimus
- Radiation: Total-Body Irradiation
- type
- EXPERIMENTAL
- label
- Schedule II (lymphoid malignancies)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available