Actively Recruiting
Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation (ADAPT)
Led by University of California, Irvine · Updated on 2026-02-02
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new conditioning regimen for allogeneic hematopoietic stem cell transplantation (AHSCT) in patients with blood cancers like AML, ALL, MDS, CML, NHL, HD, and CLL. This phase II study aims to tailor treatment based on patient risk, age, and health status to improve outcomes. The study is sponsored by the University of California, Irvine, and focuses on safety and effectiveness over a two-year follow-up period. Participants will receive a stem cell transplant after a conditioning treatment combining fludarabine, melphalan, and total body irradiation (TBI). The doses of melphalan and TBI vary according to each patient's Hematopoietic Cell Transplant Composite Risk score, age, and performance status. Additional medications after transplant include high-dose cyclophosphamide, tacrolimus, and mycophenolate mofetil to help prevent graft-versus-host disease. During the study, patients will be monitored closely for safety and treatment effects for up to two years after transplantation. Researchers will measure progression-free survival as the main outcome, along with overall survival, relapse rates, graft-versus-host disease incidence, and drug exposure levels. Assessments include health evaluations and laboratory tests to track patient condition and transplant success throughout the follow-up period.
CONDITIONS
Brief Title
Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18-70 years
- Diagnosis of AML, ALL, MDS, CML, NHL, HD, or CLL requiring allogeneic hematopoietic stem cell transplantation
- Availability of an HLA-matched related donor, HLA-matched unrelated donor, haploidentical donor, or 1-antigen mismatched unrelated donor
- Karnofsky performance status greater than 70%
- Adequate organ function including:
- Serum creatinine clearance of at least 50 ml/min
- Bilirubin of 1.5 mg/dl or less (except Gilbert's disease)
- ALT or AST of 200 IU/ml or less
- Conjugated bilirubin less than twice the upper limit of normal
- Left ventricular ejection fraction of 40% or higher
- Diffusing capacity for carbon monoxide (DLCO) of 50% or higher corrected for hemoglobin
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Inability to comply with medical recommendations or follow-up
- Pregnancy
- Active or uncontrolled bacterial or viral infection
- Active central nervous system or eye disease involvement within the past 3 months
- Diagnosis of primary central nervous system lymphoma
- Requirement for modifications of the conditioning regimen
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 days
Participants receive conditioning treatment with fludarabine, melphalan, and total body irradiation tailored based on individual risk factors before transplantation.
Daily visits from Day -5 to Day -1
Duration - Approximately 1 to 2 weeks
Participants undergo allogeneic stem cell transplantation followed by graft-versus-host disease prophylaxis with high dose cyclophosphamide, tacrolimus, and mycophenolate mofetil.
Multiple visits during and immediately after transplantation
Duration - Up to 2 years
Participants are monitored for safety and efficacy outcomes including survival and graft-versus-host disease up to 2 years post-transplantation.
Regular visits for up to 2 years post-transplant
Trial Site Locations
Total: 1 location
1
Chao Family Comprehensive Cancer Center, University of California Irvine
Orange, California, United States, 92868
Actively Recruiting
Research Team
C
Chao Family Comprehensive Cancer Center University of California, Irvine
U
University of California Irvine Medical
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here