Recruiting
Phase 1
Phase 2

Bendamustine & Cyclophosphamide

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT04022239

Conditions

Hematopoietic and Lymphoid System Neoplasm

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Allogeneic Hematopoietic Stem Cell Transplantation

Bendamustine

Cyclophosphamide

Filgrastim-sndz

Fludarabine

Study Details

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.

Conditions

Hematopoietic and Lymphoid System Neoplasm

Study ID

NCT04022239

Start date

Mar 13, 2020

Status verified date

Jul, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Schedule I (non-lymphoma)

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.

experimental: Schedule II (lymphoid malignancies)

Patients receive fludarabine IV over 1 hour, bendamustine IV over 30-60 minutes on days -5 to -3 and undergo TBI on day -1 and stem cell transplantation 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. CD20+ patients receive rituximab IV over 4-6 hours on days -13, -6, 1, and 8.

Interventions

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo stem cell transplantation

Bendamustine

Given IV

Cyclophosphamide

Given IV

Filgrastim-sndz

Given SC

Fludarabine

Given IV

Melphalan

Given IV

Mycophenolate Mofetil

Given PO

Rituximab

Given IV

Tacrolimus

Given IV and PO

Total-Body Irradiation

Undergo TBI

Primary outcome measure

  • Maximum tolerated dose level (MTDL) (Phase I) [ Time Frame: Up to 30 days ]
  • Dose-limiting toxicity (Phase I) [ Time Frame: Up to 100 days ]
  • Incidence of adverse events (Phase II) [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Issa F. Khouri, M D

713-745-0049ikhouri@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Issa F. Khouri

713-745-0049ikhouri@mdanderson.org

Principal Investigator:

Issa F. Khouri

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-07-16.