Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Could a lower dose of a transplant drug be better for blood cancer patients?

NCT ID NCT05436418

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 1 time

Summary

This study is testing whether a lower dose of the drug cyclophosphamide, given after a stem cell transplant, can prevent graft-versus-host disease (a common complication where donor cells attack the patient's body) while still being effective. The trial involves 260 adults with blood cancers who are receiving stem cells from a related donor. Participants will get different doses of cyclophosphamide along with other immune-suppressing drugs, and researchers will track their recovery and side effects for up to 5 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cyclophosphamide
What this could lead to
If successful, this could lead to a safer, more effective way to prevent graft-versus-host disease after stem cell transplants, improving outcomes for blood cancer patients.
What could go wrong
This is an early-phase trial (Phase I/II) with a small number of participants, so results may not apply to everyone. Lowering the dose might also reduce its effectiveness in preventing graft-versus-host disease or controlling the cancer.

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 260 people

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

Started

Nov 2022

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

12 to 120 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: Recipient * Participants must have a histologically or cytologically confirmed hematologic malignancy with standard indication for allogeneic hematopoietic cell transplantation limited to one of the following: * Acute myeloid leukemia (AML) of intermediate or adverse risk disease by the 2017 European LeukemiaNet criteria in first morphologic complete remission (\<5% blasts in the bone marrow, no detectable abnormal peripheral blasts, and no extramedullary disease) * AML of any risk in second or subsequent morphologic complete remission * Acute lymphoblastic leukemia in first or subsequent complete remission * Myelodysplastic syndrome of intermediate or higher score by the Revised International Prognostic Scoring System (IPSS-R) * Primary myelofibrosis of intermediate-2 or higher risk by the DIPSS * Chronic myelomonocytic leukemia * Chronic myelogenous leukemia resistant to or intolerant of \>= 3 tyrosine kinase inhibitors or with history of accelerated phase or blast crisis * B-cell lymphoma including Hodgkin lymphoma that has relapsed within 1 year of completion of primary treatment, relapsed after autologous transplantation, or has progressed through at least 2 lines of therapy * Chronic lymphocytic leukemia with 17p deletion and/or unmutated IgHV or refractory to or intolerant of both BTK and PI3K inhibitors * Mature T or NK neoplasms as defined in the WHO guidelines of sufficient type and severity for allogeneic HCT based on the Prognostic Index for T-cell lymphoma (PIT) score of low-intermediate risk or higher or on recently published clinical practice guidelines * Hematologic malignancy of dendritic cell or histiocytic cell type * Multiple myeloma, stage III, relapsing after therapy with both a proteasome inhibitor and an immunomodulatory drug (IMiD) * Age \>= 50 years or age 18-49 years and also meeting one of the following criteria: * Prior myeloablative HCT * Prior exposure to inotuzumab, gemtuzumab, or other agent that increases the risk for sinusoidal obstruction syndrome. * Hematopoietic Cell Transplantation- Comorbidity Index (HCT-CI) \>= 3 * Karnofsky performance score \<80 * Co-morbidity considered by the treating physician to be exclusionary of myeloablative conditioning * At least one potentially suitable HLA-haploidentical or 10/10 (HLA-A, B, C, DR, DQ) related or unrelated donor for HCT * Karnofsky performance score \>= 70 * Adequate organ function defined as possessing all of the following: * Cardiac ejection fraction \>= 45% by 2D ECHO; * Forced expiratory volume-1 (FEV-1), forced vital capacity (FVC), and diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) all of \>= 50% predicted; * Estimated serum creatinine clearance of \>= 60 ml/minute/1.73m\^2 calculated using eGFR in the clinical lab; * Total bilirubin \<= 2X the upper limit of normal; * Alanine aminotransferase and aspartate aminotransferase \<= 3X the upper limit of normal. * Individuals of child-bearing potential (IOCBP) and participants who can father children must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least one year post-transplant. * IOCBP must have a negative serum or urine pregnancy test within 7 days prior to initiation of conditioning regimen. * Ability of participant to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: Recipient * Participants who are receiving any other investigational agents. Prior experimental therapies must have been completed at least 2 weeks prior to the date of beginning conditioning. * Active nursing. * Active malignancy of non-hematopoietic type (excluding non-melanoma skin cancers) which is: metastatic, or relapsed/refractory to treatment, or locally advanced and not amenable to curative treatment, or limited disease treated with curative intent treatment within the last 2 years. This excludes non-melanoma skin cancers. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents. * Uncontrolled intercurrent illness (e.g., severe endocrinopathy, disseminated intravascular coagulation, profound electrolyte disturbance, active infectious hepatitis, uncontrolled dental infection) that in the opinion of the Site PI would make it unsafe to proceed with transplantation. INCLUSION CRITERIA: Donor * Related (age \>=12) and unrelated (age \>=18) donors deemed eligible (i.e., evaluated at NIH, COH, and FHCC in accordance with existing institutional Standard Policies and Procedures or evaluated per the standards required by the IRB of the National Marrow Donor Program or applicable registry), and willing to donate research samples will be included. * Ability of participant or parent/legal guardian to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: Donor None

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute lymphoblastic leukemia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    2 sites. 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

  • City of Hope

    NOT_YET_RECRUITING

    Duarte, California, 91010, United States

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.