Efficacy of Idarubicin, Cytarabine and Cyclophosphamide (IAC) Regimen in Relapsed/Refractory AML

NCT02937662 | Completed Phase 2

• 1 other identifier: IIT2016006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In this multi-center, randomized, open-label, prospective clinical trial, a total of 60 relapsed/refractory AML patients will be randomized into 2 groups. In the experimental arm, patients receive IAC regimen. In the control arm, patients receive other physician-directed regimen. The primary end point is complete remission rate.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Complete Remission Rate

  Within 6 weeks after induction therapy

Secondary Outcomes (3)

• Overall Survival(OS)

  Up to 3 years

• Relapse-Free Survival(RFS)

  Up to 3 years

• Time to Treatment Failure(TTF)

  Up to 3 years

Study Arms (2)

IAC regimen

EXPERIMENTAL

Patients receive IAC regimen including idarubicin, cytarabine and cyclophosphamide.

Drug: Idarubicin; Drug: Cytarabine; Drug: Cyclophosphamide

Control Group

ACTIVE COMPARATOR

Patients receive physician-directed regimens without cyclophosphamide including FLA±G regimen, AAG regimen, decitabine with AA regimen. Physicians can choose one of these regimens based on their experience and patients' condition.

Drug: Physician-Directed Regimens without Cyclophosphamide

Interventions

Idarubicin DRUG

Idarubicin at a dose of 10 mg/㎡/d on days 1-3.

IAC regimen

Cytarabine DRUG

Cytarabine at a dose of 100mg/㎡/d on days 1-7.

Also known as: Ara-c

IAC regimen

Cyclophosphamide DRUG

Cyclophosphamide at a dose of 350mg/㎡/d on the second day and the fifth day.

Also known as: CTX

IAC regimen

Physician-Directed Regimens without Cyclophosphamide DRUG

Regimen without cyclophosphamide including FLA±G regimen, DA regimen, AAG regimen, decitabine with AA regimen.

Control Group

Eligibility Criteria

• Age: 0 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age of less than 60 years old;
• Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes).
• Patients with a confirmed pathologic diagnosis of AML which had relapsed or refractory.
• Patients with ECOG score of ≤ 2;
• Adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. Patients under 18 years old willing to participate should have their legal guardians sign the informed consent.

You may not qualify if:

• Patients who had received reinduction therapy including cyclophosphamide are excluded. However, patients who had received regimens including cyclophosphamide before relapse are eligible.
• Patients with other blood diseases(for example, haemophiliacs) are excluded.
• Relapsed patients with only extramedullary leukemia;
• After allogeneic hematopoietic stem cell transplantation;
• With mutation of breakpoint cluster region-Abelson(BCR-ABL) fusion gene and in need of tyrosine kinase inhibitors therapy;
• Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;
• Had other malignant tumor in need of treatment;
• Had active cardiovascular disease;
• Patients with other factors which were considered unsuitable to participate in the study by the investigators.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Idarubicin; Cytarabine; Cyclophosphamide

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• Jianxiang Wang, Dr

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 18, 2016
• Study Start: October 1, 2016
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: May 30, 2025

Record last verified: 2019-03

Locations

CN (1)