Recruiting
Phase 2

Risk-ADAPTed Conditioning

Sponsor:

UCLA

Code:

NCT06028828

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation

Allogeneic Stem Cell Transplantation

Hematologic Malignancies

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Fludarabine

Melphalan

Total Body Irradiation

Study Details

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.

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation

Allogeneic Stem Cell Transplantation

Hematologic Malignancies

Study ID

NCT06028828

Start date

Sep 11, 2023

Status verified date

Jan, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Patients with AML, ALL, MDS, CML, NHL, HD, CLL requiring AHSCT

Patients will be treated with allogeneic stem cell transplantation (AHSCT) using fludarabine, melphalan and total body irradiation (TBI) conditioning with different melphalan and TBI doses based on their Hematopoietic Cell Transplant - Composite Risk (HCT-CR), age, and Karnofski performance status (KPS).

Interventions

Fludarabine

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

Melphalan

Given Day-5

Total Body Irradiation

Given Day-1

Primary outcome measure

  • Progression-free survival (PFS) [ Time Frame: Up to 48 months ]

Central Contacts and Locations

Central contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

1-877-827-8839ucstudy@uci.edu

Locations

Chao Family Comprehensive Cancer Center, University of California Irvine

Recruiting

Orange, California, United States, 92868

Contacts

Stefan O Ciurea, MD

877-827-8839ucstudy@uci.edu

More Information

Sponsor

University of California, Irvine

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Keywords

  • Allogeneic Hematopoietic Stem Cell Transplantation
  • Allogeneic Stem Cell transplantation
  • AHSCT
  • Hematologic malignancies
  • Melphalan
  • Hematopoietic stem cell transplant -composite risk

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-02-02.