MRD-directed Therapy for Low-risk and Intermediate-risk AML.

NCT02870777 | Completed Phase 2 DMC

• 1 other identifier: MRD directed therapy-AML-2016
• Study Type: interventional
• Target: 743
• Locations: 1 country
• Sites: 1

Brief Summary

Acute myeloid leukemia(AML) patients with favorable and intermediate cytogenetics at diagnosis are generally excluded from first-line allo-SCT. However, these patients may eventually relapse in some cases. Our previous study found that stratification of treatment based on cytogenetics and therapeutic response could benefit low and intermediate AML. To further verify the results, we conducted a prospective multi-center study. The purpose of this study is to establish risk stratification based on cytogenetics and minimal-residual-disease (MRD) analysis to determine whether a MRD-directed therapy for low and intermediate AML patients has positive results in terms of overall survival.

Conditions

Acute Myeloid Leukemia; Minimal Residual Disease

Keywords

MRD; Acute myeloid leukemia

Outcome Measures

Primary Outcomes (1)

• disease-free survival (DFS)

  3 year

Secondary Outcomes (3)

• leukemia relapse rate

  3 year

• disease-free survival (DFS)

  3 year

• overall survival (OS)

  3 year

Study Arms (1)

MRD-directed therapy

EXPERIMENTAL

Combination Product: MRD-directed therapy

Interventions

MRD-directed therapy COMBINATION_PRODUCT

The purpose of this study is to establish risk stratification based on cytogenetics at diagnosis and MRD analysis after induction chemotherapy and before consolidation chemotherapy to determine whether a MRD directed therapy for low and intermediate AML patients has positive results in terms of overall survival.

MRD-directed therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Low-risk and intermediate-risk AML Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

You may not qualify if:

• Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) Patients with any conditions not suitable for the trial (investigators' decision)

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Guangzhou First People's Hospital: collaborator
• Zhujiang Hospital: collaborator
• Peking University People's Hospital: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: MRD-directed therapy

Study Record Dates

• First Submitted: August 14, 2016
• First Posted: August 17, 2016
• Study Start: August 1, 2016
• Primary Completion: August 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 4, 2020

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)