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New drug combo aims to prevent dangerous transplant complication

NCT ID NCT04022239

Disease control Sponsor: M.D. Anderson Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This study tests the safety and best dose of bendamustine, given with or without cyclophosphamide, to prevent graft-versus-host disease (GVHD) in people with blood cancers receiving a stem cell transplant. About 25 participants will receive the drug after transplant, along with standard anti-rejection medicines. The goal is to find a dose that reduces GVHD without causing too many side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2020

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hematopoietic and lymphoid system neoplasm

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • M D Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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