Could a lower dose of a transplant drug be better for blood cancer patients?
NCT ID NCT05436418
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 Hide 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.
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.
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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_RECRUITINGDuarte, California, 91010, United States
-
National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Platelet-Boosting drug help control a rare bone marrow disorder?
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can adding venetoclax make donor stem cell transplants safer for High-Risk blood cancers?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas