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
Conditions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06028828
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