Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 2

HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide

NCT04904588 · View on ClinicalTrials.gov ↗

Study Summary

This is a prospective, multi-center, Phase II study of hematopoietic cell transplantation (HCT) using human leukocyte antigen (HLA)-mismatched unrelated donors (MMUD) for peripheral blood stem cell transplant in adults and bone marrow stem cell transplant in children. Post-transplant cyclophosphamide (PTCy), tacrolimus and mycophenolate mofetil (MMF) will be used for for graft versus host disease (GVHD) prophylaxis. This trial will study how well this treatment works in patients with hematologic malignancies.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • DRUG Busulfan
  • RADIATION Total-body irradiation

Study Locations (20)

California

  • City of Hope National Medical Center — Duarte
  • University of California San Francisco — San Francisco
  • Stanford University — Stanford

Florida

  • University of Florida Health Shands Hospital — Gainesville
  • University of Miami Sylvester Cancer Center — Miami
  • H. Lee Moffitt Cancer Center and Research Institute — Tampa

Georgia

  • Children's Healthcare of Atlanta — Atlanta
  • Emory University Medical Center — Atlanta

Illinois

  • Northwestern University — Chicago
  • The University of Chicago — Chicago

Maryland

  • University of Maryland Medical Center — Baltimore
  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore

Massachusetts

  • Tufts Medical Center — Boston
  • Dana Farber Cancer Institute — Boston

Michigan

  • University of Michigan Medical Center - Mott Children's Hospita — Ann Arbor
  • Karmanos Cancer Institute — Detroit

Colorado

  • Colorado Blood Cancer Institute — Denver

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2021-09-30
Est. Completion 2026-12
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04904588

The ClinicalTrials.gov registry entry for NCT04904588 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Center for International Blood and Marrow Transplant Research, which has 16 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 8 conditions, with Lymphoma appearing as the primary indexed condition, and to 4 interventions — of which Cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04904588 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04904588 about?

NCT04904588 is a clinical study titled "HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide". This is a prospective, multi-center, Phase II study of hematopoietic cell transplantation (HCT) using human leukocyte antigen (HLA)-mismatched unrelated donors (MMUD) for peripheral blood stem cell transplant in adults and bone marrow stem cell transplant in children. Post-transplant cyclophosphamid...

What is the current status of trial NCT04904588?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2021-09-30. Estimated completion is 2026-12.

What conditions does trial NCT04904588 study?

This clinical trial studies the following conditions: Lymphoma, Myelodysplastic Syndromes, Chronic Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04904588?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Busulfan (DRUG), Total-body irradiation (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04904588?

This trial is sponsored by Center for International Blood and Marrow Transplant Research, which has 16 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04904588 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial