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Recruiting NCT06028828

Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation

Phase II Interventional Allogeneic Hematopoietic Stem Cell Transplantation Allogeneic Stem Cell Transplantation Hematologic Malignancies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fludarabine, Melphalan, Total Body Irradiation.
Who it may be relevant to
Registry conditions: Allogeneic Hematopoietic Stem Cell Transplantation, Allogeneic Stem Cell Transplantation, Hematologic Malignancies. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation (ADAPT)

Overview

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.

Interventions

  • Drug Fludarabine
    Given Day-5, Day-4, Day-3, Day-2
  • Drug Melphalan
    Given Day-5
  • Radiation Total Body Irradiation
    Given Day-1

Primary outcome measures

  • Progression-free survival (PFS) [Time frame: Up to 48 months]
Secondary outcome measures (6)
  • Overall survival (OS) [Time frame: Up to 48 months]
  • Cumulative incidence of Graft-Versus-Host-Free, relapse-free survival (GRFS) [Time frame: Up to 48 months]
  • Cumulative incidence of relapse [Time frame: Up to 48 months]
  • Cumulative incidence of Non-Relapse Mortality (NRM) [Time frame: Up to 48 months]
  • Cumulative incidence of acute and chronic graft versus host disease (GVHD) [Time frame: Up to 48 months]
  • Area Under the Curve (AUC) of Melphalan [Time frame: From melphalan infusion start time to 22 hours after the infusion.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Chao Family Comprehensive Cancer Center, University of California Irvine — Orange

Identifiers

NCT: NCT06028828 · 3095 · UCI 21-90

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗