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Anti-metabolites

Stem Cell Transplant Conditioning for Blood Cancers (ADAPT Trial)

Phase 2

Recruiting

Led By Stefan O. Ciurea, MD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of AML, ALL, MDS, MPN, 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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 months

Awards & highlights

ADAPT Trial Summary

This trial studies an allogeneic stem cell transplant to treat patients with different levels of risk. Treatment involves fludarabine, melphalan and total body irradiation.

Who is the study for?

Adults aged 18-70 with certain blood cancers like AML, ALL, MDS, and others needing a stem cell transplant can join. They must have a matched donor, good organ function (liver, heart, kidneys), and be able to follow the study plan. Pregnant individuals or those with active infections or CNS diseases cannot participate.Check my eligibility

What is being tested?

The trial is testing a new way to prepare patients for stem cell transplants using drugs Fludarabine and Melphalan plus Total Body Irradiation. The doses vary based on each patient's risk factors in this phase II study where everyone gets the same treatment.See study design

What are the potential side effects?

Possible side effects include damage to organs from radiation, low blood counts from chemotherapy which increases infection risk; nausea; mouth sores; liver issues; heart problems; lung changes affecting breathing.

ADAPT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a blood cancer that needs a stem cell transplant.

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I have a donor that matches my HLA type.

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My bilirubin level is 1.5 mg/dl or lower, except if I have Gilbert's disease.

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I am mostly able to care for myself but may need help.

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I am between 18 and 70 years old.

ADAPT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival (PFS)

Secondary outcome measures

Area Under the Curve (AUC) of Melphalan

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

Cumulative incidence of Non-Relapse Mortality (NRM)

+3 more

ADAPT Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients with AML, ALL, MDS, CML, NHL, HD, CLL requiring AHSCTExperimental Treatment3 Interventions

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Melphalan

2008

Completed Phase 3

~1500

Fludarabine

2012

Completed Phase 3

~1100

Total Body Irradiation

2006

Completed Phase 3

~820

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor

544 Previous Clinical Trials

1,922,983 Total Patients Enrolled

Stefan O. Ciurea, MDPrincipal InvestigatorChao Family Comprehensive Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for participants in this clinical investigation?

"In accordance with clinicaltrials.gov, this medical experiment is in search of applicants. It was initially published on September 11th 2023 and last edited on the 14th of that same month."

Answered by AI

How many participants are currently receiving treatment as part of this investigation?

"Affirmative. Clinicaltrials.gov corroborates that this clinical trial, which was first posted on September 11th 2023, is actively searching for volunteers. A total of 60 individuals from a single site need to be enrolled in the study."

Answered by AI

Does the FDA officially sanction autologous hematopoietic stem cell transplantation for individuals suffering from acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndromes, myeloproliferative neoplasms, chronic myelogenous leukemia, non-Hodgkin’s lymphoma, Hodgkin’s disease or chronic lymphocytic diseases?

"In our analysis, the safety of individuals with Acute Myeloid Leukemia (AML), Acute lymphoblastic leukemia (ALL), Myelodysplastic syndrome (MDS), Myeloproliferative Neoplasm (MPN) Chronic myelogenous leukemia(CML), Non-Hodgkin's lymphoma(NHL ), Hodgkin's Disease (HD) and chronic lymphocytic leukaemia (CLL ) undergoing Autologous Hematopoietic Stem Cell Transplantation was estimated to be a 2 due to limited efficacy data from Phase 2 trials."

Answered by AI

Are individuals under the age of 35 being included in this research endeavor?

"This medical trial has a minimum permissible age of 18 years and the upper limit is 70."

Answered by AI

Could I be considered a viable participant for this medical research?

"Eligible participants for this trial must have undergone a bone marrow transplant and be aged between 18-70 years old. The researchers are aiming to recruit 60 subjects in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation

Stefan Octavian Ciurea 2023. "Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06028828.