- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06028828
Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation (ADAPT)
Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation (ADAPT)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Chao Family Comprehensive Cancer Center University of California, Irvine
- Phone Number: 1-877-827-8839
- Email: ucstudy@uci.edu
Study Contact Backup
- Name: University of California Irvine Medical
Study Locations
-
-
California
-
Orange, California, United States, 92868
- Recruiting
- Chao Family Comprehensive Cancer Center, University of California Irvine
-
Contact:
- Stefan O Ciurea, MD
- Phone Number: 877-827-8839
- Email: ucstudy@uci.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients with AML, ALL, MDS, CML, NHL, HD, CLL requiring AHSCT
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).
|
Given Day-5, Day-4, Day-3, Day-2
Given Day-5
Given Day-1
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 48 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 48 months
|
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.
|
Up to 48 months
|
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.
|
Up to 48 months
|
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.
|
Up to 48 months
|
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.
|
Up to 48 months
|
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.
|
From melphalan infusion start time to 22 hours after the infusion.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stefan O. Ciurea, MD, Chao Family Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Hematologic Diseases
- Neoplasms
- Hematologic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Melphalan
- Fludarabine
Other Study ID Numbers
- 3095 (University of California, Irvine)
- UCI 21-90 (Other Identifier: UCI CFCCC)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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