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NCT06001385 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Lymphoma and Acute Myeloid Leukemia, sponsored by Center for International Blood and Marrow Transplant Research.

Active
Registry status
Phase 2
Development phase
313
Enrollment target
20
Study locations

NCT06001385 is a Phase 2 study of Lymphoma and Acute Myeloid Leukemia that is active but no longer recruiting, run by Center for International Blood and Marrow Transplant Research. The registered enrollment target is 313 participants, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (35% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT06001385, a Phase 2 study of Lymphoma and Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by Center for International Blood and Marrow Transplant Research.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
313 participants
Enrollment target
20
Study locations

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

What the Registry Record Tells You About NCT06001385

The ClinicalTrials.gov registry entry for NCT06001385 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 313 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (35% lower). The listed sponsor is Center for International Blood and Marrow Transplant Research, which has 29 total studies on file at ClinicalTrials.gov.

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.

NCT06001385 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Florida, Arizona.

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.

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).

Who is sponsoring clinical trial NCT06001385?

This trial is sponsored by Center for International Blood and Marrow Transplant Research, which has 29 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.