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"InDACtion" vs "3+7" Induction in AML

NCT02172872 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 606

Last updated 2023-02-15

No results posted yet for this study

Summary

Older patients with acute myeloid leukemia (AML) have a small (\< 10%) chance of long-term survival. Despite the treatment of elderly AML patients with intensive chemotherapy, the survival has not been improved during the last decades.

The purpose of this study is to determine whether frontline therapy with a 10-day decitabine schedule provides a better survival than standard intensive combination chemotherapy in elderly AML patients (\>= 60 years).

Conditions

  • Acute Myeloid Leukemia (AML)

Interventions

DRUG

standard combination chemotherapy

1. Cycle 1 1. daunorubicin (60 mg/m²) infusion (15-30 min) for 3 days 2. cytarabine (200 mg/m²) continuous infusion (24 hrs) for 7 days. 2. Cycle 2 1. daunorubicin (45 mg/m²) infusion (15-30 min) for 3 days 2. cytarabine (200 mg/m²) continuous infusion (24 hrs) for 7 days. 3. Cycle 3 (mini-ICE) 1. idarubicin (8 mg/m²) infusion (15-30 min) for 3 days 2. cytarabine (100 mg/m²) continuous infusion (24 hrs) for 5 days 3. etoposide (100 mg/m²) infusion (1 hr) for 3 days 4. Cycle 4 (mini-ICE) (optional) 1. idarubicin (8 mg/m²) infusion (15-30 min) for 3 days 2. cytarabine (100 mg/m²) continuous infusion (24 hrs) for 5 days 3. etoposide (100 mg/m²) infusion (1 hr) for 3 days

DRUG

decitabine

1. Cycle 1: decitabine (20 mg/m²) infusion (1 hr) for 10 days 2. Cycle 2 1. if bone marrow (BM) blasts \< 5%: decitabine (20 mg/m²) infusion (1 hr) for 5 days 2. if BM blasts \>= 5%: decitabine (20 mg/m²) infusion (1 hr) for 10 days 3. Cycle 3 1. if BM blasts \< 5%: decitabine (20 mg/m²) infusion (1 hr) for 5 days 2. if BM blasts \>= 5%: decitabine (20 mg/m²) infusion (1 hr) for 10 days 4. Cycle 4-6: decitabine (20 mg/m²) infusion (1 hr) for 5 days 5. Continuation therapy from Cycle 7 and until 'progression or toxicity': decitabine (20 mg/m²) infusion (1 hr) for 5 days or 3 days Note: All patients considered eligible for transplant should be consolidated with alloHCT once donor is available.

Sponsors & Collaborators

  • Janssen Pharmaceuticals

    collaborator INDUSTRY

  • Gruppo Italiano Malattie EMatologiche dell'Adulto

    collaborator OTHER

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Michael Luebbert, MD, PhD · Universitaetsklinikum Freiburg, Freiburg, Germany

  • Gerwin G Huls, MD, PhD · UMCG, Groningen, The Netherlands

  • Pierre W Wijermans, MD · HagaZiekenhuis, the Hague, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-28
Primary Completion
2022-03-07
Completion
2023-12-31

Countries

  • Belgium
  • Bulgaria
  • Croatia
  • France
  • Germany
  • Italy
  • Lithuania
  • Netherlands
  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02172872 on ClinicalTrials.gov