Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing Melphalan for Peripheral Blood Stem Cell Transplantation

Background: Blood cancers (such as leukemias or lymphomas) often do not respond to standard treatments. A transplant of blood stem cells from a healthy donor can help people with these cancers.

Official registry: https://clinicaltrials.gov/study/NCT05436418 · National Cancer Institute (NCI) · enrollment listed as 260

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Melphalan, Sirolimus, or Total Body Irradiation (TBI). The registry lists allocation as na. Background: Blood cancers (such as leukemias or lymphomas) often do not respond to standard treatments.

They plan to enroll about 260 people at 2 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.

Official title (unrewritten)

Phase I/II Trial to Determine the Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination w Sirolimus and Mycophenolate Mofetil as GVHD Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation

Interventions: Melphalan, Sirolimus, Total Body Irradiation (TBI), Cyclophosphamide, Mycophenolate Mofeti, Fludarabine, Allogeneic HSCT, Mesna, Filgrastim

Primary outcome (registry wording): Phase II: Evaluate the efficacy of PTCy, at the lowest dose determined for each HLA-matching arm from phase I, as assessed by 1-year GVHD-free relapse-free survival (GRFS) rate.

Who it is for (from inclusion criteria)

  • Ages 12 Years to 120 Years
  • 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

Public study contact (from the registry)

Amy H Chai

(240) 858-3755

amy.chai@nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

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FAQ about this NCT record

Is NCT05436418 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05436418?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05436418?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary