Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation

NCT06028828 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 3095UCI 21-90
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  PFS is defined as the time from stem cell infusion to time of disease relapse or death from any cause; data for patients who were alive without relapse will be censored at the date of last contact.

  Up to 48 months

Secondary Outcomes (6)

• Overall survival (OS)

  Up to 48 months

• Cumulative incidence of Graft-Versus-Host-Free, relapse-free survival (GRFS)

  Up to 48 months

• Cumulative incidence of relapse

  Up to 48 months

• Cumulative incidence of Non-Relapse Mortality (NRM)

  Up to 48 months

• Cumulative incidence of acute and chronic graft versus host disease (GVHD)

  Up to 48 months

Study Arms (1)

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

EXPERIMENTAL

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).

Drug: Fludarabine; Drug: Melphalan; Radiation: Total Body Irradiation

Interventions

Fludarabine DRUG

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

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

Melphalan DRUG

Given Day-5

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

Total Body Irradiation RADIATION

Given Day-1

Also known as: TBI

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18-70 years
• Diagnosis of AML, ALL, MDS, CML, NHL, HD, CLL requiring AHSCT
• Has an HLA-matched related (MRD), HLA-matched unrelated (MUD), haploidentical (HAPLO) or 1-Ag mismatched unrelated donor (MMUD)
• Karnofsky performance \>70%
• Adequate major organ system function as demonstrated by:
• Serum creatinine clearance equal or more than 50 ml/min (calculated with Cockroft-Gault formula).
• 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.
• Left ventricular ejection fraction equal or greater than 40%.
• Diffusing capacity for carbon monoxide (DLCO) equal or greater than 50% predicted corrected for hemoglobin.
• 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.

You may not qualify if:

• Inability to comply with medical recommendations or follow-up
• Pregnancy
• Active/uncontrolled bacterial or viral infection (PI is the final arbiter of this criterion.)
• Has active CNS or ocular disease involvement within 3 months
• Patients with primary CNS lymphoma
• Patients who require modifications of the conditional regimen

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Chao Family Comprehensive Cancer Center, University of California Irvine

Orange, California, 92868, United States

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

fludarabine; Melphalan; Whole-Body Irradiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Radiotherapy; Therapeutics; Investigative Techniques

Study Officials

• Stefan O. Ciurea, MD

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

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

University of California Irvine Medical

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Medicine

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 8, 2023
• Study Start: September 11, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

US (1)