RecruitingPhase 2NCT06028828

Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation

Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation (ADAPT)

Sponsor

University of California, Irvine

Enrollment

60 participants

Start Date

Sep 11, 2023

Study Type

INTERVENTIONAL

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria10

Male or female aged 18-70 years
Diagnosis of AML, ALL, MDS, CML, NHL, HD, CLL requiring AHSCT
Has an HLA-matched related (MRD), HLA-matched unrelated (MUD), haploidentical (HAPLO) or 1-Ag mismatched unrelated donor (MMUD)
Karnofsky performance >70%
Adequate major organ system function as demonstrated by:
Serum creatinine clearance equal or more than 50 ml/min (calculated with Cockroft-Gault formula).
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.
Left ventricular ejection fraction equal or greater than 40%.
Diffusing capacity for carbon monoxide (DLCO) equal or greater than 50% predicted corrected for hemoglobin.
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.

Exclusion Criteria6

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

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Interventions

DRUGFludarabine

Given Day-5, Day-4, Day-3, Day-2

DRUGMelphalan

Given Day-5

RADIATIONTotal Body Irradiation

Given Day-1

Locations(1)

Chao Family Comprehensive Cancer Center, University of California Irvine

Orange, California, United States

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NCT06028828