RECRUITING

Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation Allogeneic Stem Cell Transplantation Hematologic Malignancies AHSCT Melphalan Hematopoietic stem cell transplant -composite risk

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2023-09-11

Study Completion:2027-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06028828

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-8839

ucstudy@uci.edu

University of California Irvine Medical

CONTACT

Principal Investigator

Stefan O. Ciurea, MD

PRINCIPAL_INVESTIGATOR

Chao Family Comprehensive Cancer Center

Study Locations (Sites)

Chao Family Comprehensive Cancer Center, University of California Irvine

Orange, California, 92868

United States

Collaborators and Investigators

Sponsor: University of California, Irvine

Stefan O. Ciurea, MD, PRINCIPAL_INVESTIGATOR, Chao Family Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-11

Study Completion Date2027-09

Study Record Updates

Study Start Date2023-09-11

Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic Stem Cell Transplantation
Hematologic Malignancies