Health TrialsbyHealthPanel

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

ConditionHematopoietic and Lymphoid System Neoplasm
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorM.D. Anderson Cancer Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Patient with hematologic malignancies.

Donor: Matched sibling, matched unrelated, mismatched or haploidentical

Zubrod performance 0 to 2 or Karnofsky of at least 60.

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

Disqualifiers

Pregnant or nursing women.

Known to be HIV positive

Active and uncontrolled disease/infection

Unable or unwilling to sign consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Allogeneic Hematopoietic Stem Cell Transplantation

    Procedure/Surgery

    Undergo stem cell transplantation

  • Bendamustine

    Drug

    Given IV

  • Cyclophosphamide

    Drug

    Given IV

  • Filgrastim-sndz

    Biological/Vaccine

    Given SC

  • Fludarabine

    Drug

    Given IV

  • Melphalan

    Drug

    Given IV

  • Mycophenolate Mofetil

    Drug

    Given PO

  • Rituximab

    Biological/Vaccine

    Given IV

  • Tacrolimus

    Drug

    Given IV and PO

  • Total-Body Irradiation

    Radiation

    Undergo TBI

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: Schedule I (non-lymphoma)Experimental treatment 9 interventions
Group B: Schedule II (lymphoid malignancies)Experimental treatment 9 interventions

Trial outcomes

Primary outcomes

1

Maximum tolerated dose level (MTDL) (Phase I)

Will employ the time-to-event Bayesian optimal interval design to find the MTDL. After the trial is completed, the MTDL will be selected based on isotonic regression as specified in Yuan et al. Specifically, MTDL will be selected as the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate. If there are ties, the higher dose level when the isotonic estimate is lower than the target toxicity rate will be selected and the lower dose level when the isotonic estimate is greater than or equal to the target toxicity rate will be selected.

Time frame
Up to 30 days
2

Dose-limiting toxicity (Phase I)

Time frame
Up to 100 days
3

Incidence of adverse events (Phase II)

The trial is continuously monitored for toxicity per the statistical design.

Time frame
Up to 2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
Apply now