Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT06028828

Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation

Led by University of California, Irvine · Updated on 2026-02-02

60

Participants Needed

1

Research Sites

207 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  1. Male or female aged 18-70 years

  2. Diagnosis of AML, ALL, MDS, CML, NHL, HD, CLL requiring AHSCT

  3. Has an HLA-matched related (MRD), HLA-matched unrelated (MUD), haploidentical (HAPLO) or 1-Ag mismatched unrelated donor (MMUD)

  4. Karnofsky performance >70%

  5. Adequate major organ system function as demonstrated by:

    1. Serum creatinine clearance equal or more than 50 ml/min (calculated with Cockroft-Gault formula).
    2. Bilirubin equal or less than 1.5 mg/dl except for Gilbert's disease. ALT or AST equal or less than 200 IU/ml for adults. Conjugated (direct) bilirubin less than 2x upper limit of normal.
    3. Left ventricular ejection fraction equal or greater than 40%.
    4. Diffusing capacity for carbon monoxide (DLCO) equal or greater than 50% predicted corrected for hemoglobin.
  6. Ability to understand and the willingness to sign a written informed consent. a. Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial.

Not Eligible

You will not qualify if you...

  1. Inability to comply with medical recommendations or follow-up
  2. Pregnancy
  3. Active/uncontrolled bacterial or viral infection (PI is the final arbiter of this criterion.)
  4. Has active CNS or ocular disease involvement within 3 months
  5. Patients with primary CNS lymphoma
  6. Patients who require modifications of the conditional regimen

AI-Screening

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Trial Site Locations

Total: 1 location

1

Chao Family Comprehensive Cancer Center, University of California Irvine

Orange, California, United States, 92868

Actively Recruiting

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Research Team

C

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

U

University of California Irvine Medical

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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