Personalized conditioning regimen for stem cell transplantation
Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation (ADAPT)
This study is testing a personalized treatment plan for stem cell transplants in people with blood cancers to see if adjusting the doses of certain medications can improve their outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of California, Irvine Academic / other |
| Drugs / interventions | fludarabine, cyclophosphamide |
| Locations | 1 site (Orange, California) |
| Trial ID | NCT06028828 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial aims to evaluate a tailored conditioning regimen for allogeneic hematopoietic stem cell transplantation (AHSCT) in patients with hematologic malignancies. Participants will receive a combination of fludarabine, melphalan, and total body irradiation (TBI), with doses adjusted based on individual patient and disease risk factors. The study will monitor safety and efficacy for up to two years post-transplantation, focusing on optimizing treatment outcomes through personalized dosing strategies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-70 with specific hematologic malignancies requiring AHSCT and adequate organ function.
Not a fit: Patients with severe organ dysfunction or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve transplant outcomes and reduce complications for patients undergoing stem cell transplantation.
How similar studies have performed: Other studies have shown promise with personalized conditioning regimens in stem cell transplantation, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Where this trial is running
Orange, California
- Chao Family Comprehensive Cancer Center, University of California Irvine — Orange, California, United States (Recruiting)
Study contacts
- Principal investigator: Stefan O. Ciurea, MD — Chao Family Comprehensive Cancer Center
- Study coordinator: Chao Family Comprehensive Cancer Center University of California, Irvine
- Email: ucstudy@uci.edu
- Phone: 1-877-827-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.