"InDACtion" vs "3+7" Induction in AML
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|ClinicalTrials.gov Identifier: NCT02172872|
Recruitment Status : Recruiting
First Posted : June 24, 2014
Last Update Posted : July 12, 2018
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).
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia (AML)||Drug: standard combination chemotherapy Drug: decitabine||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||10-day Decitabine Versus Conventional Chemotherapy ("3+7") Followed by Allografting in AML Patients ≥ 60 Years: a Randomized Phase III Study of the EORTC Leukemia Group, CELG, GIMEMA and German MDS Study Group|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
|Active Comparator: standard combination chemotherapy||
Drug: standard combination chemotherapy
Note: All patients considered eligible for transplant should be consolidated with alloHCT once donor is available.
Other Name: Dacogen
- Overall survival (OS) [ Time Frame: 4.9 years from first patient in ]
- Occurrence of adverse events (AEs) [ Time Frame: 4.9 years from first patient in ]The events are graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- Progression-free survival (PFS) from randomization to the date of either first progression, first relapse or death, whichever occurs first [ Time Frame: 4.9 years from first patient in ]
- Transplantation feasibility [ Time Frame: 4.9 years from first patient in ]Percentage of patients transplanted
- Outcome post-transplantation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 4.9 years from first patient in ]EORTC Quality of Life Questionnaire (QLQ-C30) Elderly module (ELD14)
- Prognostic value of baseline physical and functional conditions on treatment outcome using geriatric assessment tools [ Time Frame: 4.9 years from first patient in ]Short physical performance battery (SPPB) and activities of daily living (ADL)
- complete response (CR/CRi) rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02172872
|Contact: EORTC HQ||+32 2 774 16 firstname.lastname@example.org|
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|Study Chair:||Michael Luebbert, MD, PhD||Universitaetsklinikum Freiburg, Freiburg, Germany|
|Principal Investigator:||Gerwin G Huls, MD, PhD||UMCG, Groningen, The Netherlands|
|Principal Investigator:||Pierre W Wijermans, MD||HagaZiekenhuis, the Hague, The Netherlands|