Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at Orange, California
Dates
study started
completion around
Principal Investigator
by Stefan Octavian Ciurea

Description

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.

Official Title

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

Details

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.

Keywords

Allogeneic Hematopoietic Stem Cell Transplantation, Allogeneic Stem Cell Transplantation, Hematologic Malignancies, AHSCT, Melphalan, Hematopoietic stem cell transplant -composite risk, Neoplasms, Hematologic Neoplasms, Fludarabine, Total Body Irradiation

Eligibility

You can join if…

Open to people ages 18-70

  1. Male or female aged 18-70 years
  2. Diagnosis of AML, ALL, MDS, MPN, 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.

You CAN'T join if...

  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

Location

  • Chao Family Comprehensive Cancer Center, University of California Irvine accepting new patients
    Orange California 92868 United States

Lead Scientist at UC Irvine

  • Stefan Octavian Ciurea
    Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 227 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT06028828
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated