NCT06028828 Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation
| NCT ID | NCT06028828 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, Irvine |
| Condition | Allogeneic Hematopoietic Stem Cell Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-09-11 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2023-09-11 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Chao Family Comprehensive Cancer Center University of California, Irvine
✉ ucstudy@uci.edu📞 1-877-827-8839
Stefan O. Ciurea, MD
PRINCIPAL INVESTIGATOR
Chao Family Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT06028828 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Allogeneic Hematopoietic Stem Cell Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06028828 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06028828 currently recruiting?
Yes, NCT06028828 is actively recruiting participants. Contact the research team at ucstudy@uci.edu for enrollment information.
Where is the NCT06028828 trial being conducted?
This trial is being conducted at Orange, United States.
Who is sponsoring the NCT06028828 clinical trial?
NCT06028828 is sponsored by University of California, Irvine. The principal investigator is Stefan O. Ciurea, MD at Chao Family Comprehensive Cancer Center. The trial plans to enroll 60 participants.