Phase 1 / Phase 2: testing Mycophenolate Mofetil for Hematologic Neoplasms
Background: Certain blood cancers can be treated with blood or bone marrow transplants. Sometimes the donor cells attack the recipient's body, called graft-versus-host disease (GVHD).
Official registry: https://clinicaltrials.gov/study/NCT04959175 · National Cancer Institute (NCI) · enrollment listed as 320
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 Mycophenolate Mofetil, Allogeneic HSCT, or Fludarabine. The registry lists allocation as na. Background: Certain blood cancers can be treated with blood or bone marrow transplants.
They plan to enroll about 320 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 Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies
Interventions: Mycophenolate Mofetil, Allogeneic HSCT, Fludarabine, Sirolimus, Filgrastim, Cyclophosphamide, Mesna, Total Body Irradiation (TBI)
Primary outcome (registry wording): determine if optimal dose of PTCy to prevent grade III-IV acute GVHD (aGVHD) at day +60
Who it is for (from inclusion criteria)
- Ages 12 Years to 85 Years
- Subjects must have a histologically or cytologically confirmed hematologic malignancy with standard indication for allogeneic hematopoietic cell transplantation including, but not limited to, one of the following:
- Acute myeloid leukemia in morphologic complete remission (\<5% blasts in the bone marrow, no detectable abnormal peripheral blasts, and no extramedullary disease)
- B-cell acute lymphoblastic leukemia in first or subsequent complete remission
- T-cell 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
Who the registry excludes
- Subjects 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
- Poorly controlled malignant indication for transplantation such as:
- Leukemia not having achieved morphologic remission (i.e. bone marrow blasts \>5% or active extramedullary disease)
- Lymphoma not having achieved at least a partial response to prior chemotherapy or radiation
- Uncontrolled intercurrent illness that in the opinion of the site PI would make it unsafe to proceed with transplantation
- The potential for some of the study medications to be transmissible via breast milk of nursing mothers is unknown. Because there is unknown but potential risk for side effects in nursing infants secondary to treatment of the mother, breastfeeding must be discontinued
- who can join - Donor:
Public study contact (from the registry)
Amy H Chai
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
2 listed- National Institutes of Health Clinical Center — Bethesda, Maryland (recruiting)
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania (recruiting)
FAQ about this NCT record
Is NCT04959175 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 NCT04959175?
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 NCT04959175?
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