"InDACtion" vs "3+7" Induction in AML
- Conditions
- Acute Myeloid Leukemia (AML)
- Interventions
- Drug: standard combination chemotherapy
- Registration Number
- NCT02172872
- Brief 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).
- Detailed Description
* The overall survival (OS) of older AML patients has not been improved during the last decades with intensive chemotherapy based on cytarabine combined with an anthracycline ("3+7").
* Next generation sequencing technology reveals that mutations in genes involved in epigenetics are frequently mutated in AML (e.g. DNMT3a), suggesting an important role of epigenetics in the pathophysiology of AML. Decitabine (given in a 5-day schedule) has been shown to be superior to low-dose Ara-C.
* A retrospective analysis revealed that epigenetic therapy (either azacitidine or decitabine) is associated with similar survival rates as intensive chemotherapy in older patients (n=671) with newly diagnosed AML.
* The recently published encouraging phase 2 data with the 10-day decitabine schedule suggests that decitabine results in similar CR rates compared with intensive chemotherapy. Allogeneic transplantation (alloHCT) also offers the opportunity for cure among older AML patients, therefore treatment strategies should aim to allograft older AML patients.
* Decitabine treatment can lead to very interesting cure rates when used as "bridging" to allografting.
Based on the data summarized above, we hypothesize that decitabine at a daily dose of 20 mg/m² starting with the 10-day schedule followed by an alloHCT or by continuation of 5-days decitabine cycles is superior to conventional intensive chemotherapy in older AML patients.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 606
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description standard combination chemotherapy standard combination chemotherapy - decitabine decitabine -
- Primary Outcome Measures
Name Time Method Overall survival (OS) 4.9 years from first patient in
- Secondary Outcome Measures
Name Time Method Occurrence of adverse events (AEs) 4.9 years from first patient in The events are graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Transplantation feasibility 4.9 years from first patient in Percentage of patients transplanted
Outcome post-transplantation 4.9 years from first patient in PFS, incidence of relapse or progression, and incidence of non-relapse or progression related mortality
Health economics impact of each treatment arm 4.9 years from first patient in At the end of each cycle, duration of hospitalization and number of visits (planned or related to event), number of transfusions, growth factor support and intravenous anti-infective are collected
Health Related Quality of Life (HRQoL) questionnaires 4.9 years from first patient in EORTC Quality of Life Questionnaire (QLQ-C30) Elderly module (ELD14)
Progression-free survival (PFS) from randomization to the date of either first progression, first relapse or death, whichever occurs first 4.9 years from first patient in complete response (CR/CRi) rate 4.9 years from first patient in All patients who reached complete response (CR) or complete response with incomplete marrow recovery (CRi) after the administration of protocol treatment ("3+7" or decitabine)
Overall CR/CRi rate 4.9 years from first patient in All patients who reached CR or CRi, after administration of the protocol treatment ("3+7" or decitabine) or following another salvage/new treatment for AML (other than transplant)
Disease-free survival (DFS) from CR or CRi 4.9 years from first patient in The time between the date of CR or CRi and the date of first relapse or death (whatever the cause), whichever occurs first
Prognostic value of baseline physical and functional conditions on treatment outcome using geriatric assessment tools 4.9 years from first patient in Short physical performance battery (SPPB) and activities of daily living (ADL)
Trial Locations
- Locations (53)
UZ Antwerpen
🇧🇪Edegem, Antwerpen, Belgium
UZ Brussel
🇧🇪Jette, Brussels, Belgium
CHR Verviers
🇧🇪Verviers, Liège, Belgium
A.Z. St. Jan
🇧🇪Brugge, West-Vlaanderen, Belgium
Institut Jules Bordet
🇧🇪Brussels, Belgium
C.H.U. Sart-Tilman
🇧🇪Liège, Belgium
CHR De La Citadelle
🇧🇪Liège, Belgium
National Specialized Hospital for Active Treatment of Haematological Diseases
🇧🇬Sofia, Bulgaria
Clinical Hospital Merkur
🇭🇷Zagreb, Croatia
University Hospital Rebro
🇭🇷Zagreb, Croatia
Scroll for more (43 remaining)UZ Antwerpen🇧🇪Edegem, Antwerpen, Belgium