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NCT Number: NCT06028828

Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation

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.

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Key information

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation Allogeneic Stem Cell Transplantation Hematologic Diseases Hematologic Malignancies Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chao Family Comprehensive Cancer Center, University of California Irvine

Orange, California, 92868, United States

Location status: Recruiting

Location contact

Stefan O Ciurea, MD

CONTACT

[email protected]

877-827-8839

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fludarabine

Drug

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

melphalan

Drug

Given Day-5

Total Body Irradiation

Radiation

Given Day-1

Other names: TBI

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: Up to 48 months

    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.

Secondary outcomes

  1. Overall survival (OS)

    Time frame: Up to 48 months

    OS is defined as the time from stem cell infusion until death from any cause. Data of patients who were alive without relapse will be censored at the date of last contact.

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

    Time frame: Up to 48 months

    GRFS is defined as time from stem cell infusion to time of the first event among acute GVHD grades 3-4, extensive chronic GVHD, relapse, and death. Data of patients who are event-free will be censored at the date of last contact.

  3. Cumulative incidence of relapse

    Time frame: Up to 48 months

    Relapse is defined as re-occurrence of the disease after stem cell infusion. Cumulative incidence of relapse will be measured from date of stem cell infusion to date of disease relapse. Death without disease relapse is considered a competing risk for relapse. Data of patients who are alive without disease relapse will be censored at the date of last contact.

  4. Cumulative incidence of Non-Relapse Mortality (NRM)

    Time frame: Up to 48 months

    NRM is defined as death related to AHSCT during continuous complete remission. Cumulative incidence of NRM will be measured from date of stem cell infusion to date of death. Disease relapse is considered a competing risk for NRM. Data of patients who are alive without disease relapse will be censored at the date of last contact.

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

    Time frame: Up to 48 months

    Acute and chronic GVHD will be measured from date of stem cell infusion to date of the event. Death without GVHD is considered a competing risk for GVHD. Patients who are alive without GVHD will be censored at the date of last contact.

  6. Area Under the Curve (AUC) of Melphalan

    Time frame: From melphalan infusion start time to 22 hours after the infusion.

    AUC will be used to determine the pharmacokinetic of melphalan after the infusion on D-5. Data will be summarized using descriptive statistics.

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

[email protected]

1-877-827-8839

University of California Irvine Medical

CONTACT

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

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

Acronym: ADAPT

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Sep 8, 2023
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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