Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT06028828
Phase
PHASE2
Status
Recruiting
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Conditions

  • Allogeneic Hematopoietic Stem Cell Transplantation
  • Allogeneic Stem Cell Transplantation
  • Hematologic Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Fludarabine — DRUG
    Given Day-5, Day-4, Day-3, Day-2
  • Melphalan — DRUG
    Given Day-5
  • Total Body Irradiation — RADIATION
    Given Day-1

Study Details

This is a prospective, single-arm, phase II study. Patients will be treated with an allogeneic stem cell transplantation (AHSCT) using fludarabine, melphalan and total body irradiation (TBI) conditioning with different melphalan and TBI doses based on patient- and disease-related risk.

Key Dates

Start date
Sep 11, 2023
Status verified
Jan 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with AML, ALL, MDS, CML, NHL, HD, CLL requiring AHSCT
    Patients will be treated with allogeneic stem cell transplantation (AHSCT) using fludarabine, melphalan and total body irradiation (TBI) conditioning with different melphalan and TBI doses based on their Hematopoietic Cell Transplant - Composite Risk (HCT-CR), age, and Karnofski performance status (KPS).

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Up to 48 months ]

Central Contacts

  • Chao Family Comprehensive Cancer Center University of California, Irvine
    1-877-827-8839
    [email protected]
  • University of California Irvine Medical

Locations (1)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center, University of California IrvineOrangeCalifornia92868
Stefan O Ciurea, MD
[email protected]
877-827-8839

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By research site
Chao Family Comprehensive Cancer Center, University of California Irvine· Orange, CA

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