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

ACTIVE NOT RECRUITING Phase 2

HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation With Reduced Dose Post Transplantation Cyclophosphamide GvHD Prophylaxis

NCT06001385 · View on ClinicalTrials.gov ↗

Study Summary

The goal of this clinical trial is to determine the effectiveness of Reduced Dose Post-Transplant Cyclophosphamide (PTCy) in patients with hematologic malignancies after receiving an HLA-Mismatched Unrelated Donor (MMUD) . The main question\[s\] it aims to answer are: * Does a reduced dose of PTCy reduce the occurrence of infections in the first 100 days after transplant? * Does a reduced dose of PTCy maintain the same level of protection against Graft Versus Host Disease (GvHD) as the standard dose of PTCy?

Interventions

  • DRUG Fludarabine
  • DRUG Busulfan
  • DRUG Mesna
  • PROCEDURE PBSC Hematopoietic Stem Cell Transplantation (HSCT)
  • DRUG Post-Transplant Cyclophosphamide

Study Locations (20)

California

  • City of Hope — Duarte
  • University of California San Francisco — San Francisco
  • Stanford University — Stanford

Florida

  • Mayo Clinic Jacksonville — Jacksonville
  • University of Miami Sylvester Cancer Center — Miami
  • Moffitt Cancer Center — Tampa

Arizona

  • Mayo Clinic Arizona — Phoenix
  • Honor Health — Scottsdale

Massachusetts

  • Tufts University — Boston
  • Dana Farber Cancer Institute — Boston

Minnesota

  • University of Minnesota — Minneapolis
  • Mayo Clinic — Rochester

Arkansas

  • University of Arkansas for Medical Sciences — Little Rock

Colorado

  • Colorado Blood Cancer Institute at Presbyterian St. Luke's — Denver

Georgia

  • Emory University — Atlanta

Trial Details

FieldValue
Enrollment Target 313 participants
Start Date 2023-12-08
Est. Completion 2026-06-30
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06001385

The ClinicalTrials.gov registry entry for NCT06001385 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 313 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 10 conditions, with Lymphoma appearing as the primary indexed condition, and to 5 interventions — of which Fludarabine 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: NCT06001385 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Arizona. 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 NCT06001385 about?

NCT06001385 is a clinical study titled "HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation With Reduced Dose Post Transplantation Cyclophosphamide GvHD Prophylaxis". The goal of this clinical trial is to determine the effectiveness of Reduced Dose Post-Transplant Cyclophosphamide (PTCy) in patients with hematologic malignancies after receiving an HLA-Mismatched Unrelated Donor (MMUD) . The main question\[s\] it aims to answer are: * Does a reduced dose of PTCy ...

What is the current status of trial NCT06001385?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 313 participants. The study started on 2023-12-08. Estimated completion is 2026-06-30.

What conditions does trial NCT06001385 study?

This clinical trial studies the following conditions: Lymphoma, Acute Myeloid Leukemia, Myelodysplastic Syndromes, Chronic Lymphocytic Leukemia, Acute Lymphoblastic 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 NCT06001385?

The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG), Mesna (DRUG), PBSC Hematopoietic Stem Cell Transplantation (HSCT) (PROCEDURE), Post-Transplant Cyclophosphamide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06001385?

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 NCT06001385 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. 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