Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation

NCT ID: NCT06028828

Last Updated: 2026-02-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-11
• Study Completion Date: 2027-09-30

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.

Detailed Description

Eligible patients will receive an allogeneic stem cell transplantation using a combination of fludarabine, melphalan and total body irradiation (TBI) conditioning regimen and post-transplant high dose cyclophosphamide (PTCY), tacrolimus and mycophenolate mofetil (MMF) for graft-versus-host prophylaxis.

Melphalan and TBI doses will be tailored based on the Hematopoietic Stem Cell Transplant- Composite Risk (HCT-CR), age and Karnofski performance status (KPS). Melphalan dose ranges from 100 -140 mg/m2 while TBI dose ranges from 2-5 Gy.

All patients will be monitored for safety and efficacy up to 2 years post-transplantation.

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation; Allogeneic Stem Cell Transplantation; Hematologic Malignancies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Fludarabine

Intervention Type: DRUG

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

Melphalan

Intervention Type: DRUG

Given Day-5

Total Body Irradiation

Intervention Type: RADIATION

Given Day-1

Interventions

Fludarabine

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

Intervention Type: DRUG

Melphalan

Given Day-5

Intervention Type: DRUG

Total Body Irradiation

Given Day-1

Intervention Type: RADIATION

Other Intervention Names

TBI

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Stefan Octavian Ciurea

Professor of Clinical Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan O. Ciurea, MD

Role: PRINCIPAL_INVESTIGATOR

Chao Family Comprehensive Cancer Center

Locations

Chao Family Comprehensive Cancer Center, University of California Irvine

Orange, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

Role: CONTACT

ucstudy@uci.edu

1-877-827-8839

University of California Irvine Medical

Role: CONTACT

Facility Contacts

Stefan O Ciurea, MD

Role: primary

ucstudy@uci.edu

877-827-8839

Other Identifiers

UCI 21-90

Identifier Type: OTHER

Identifier Source: secondary_id

3095

Identifier Type: -

Identifier Source: org_study_id