Status:
COMPLETED
Study of Low-Dose Cytarabine and Etoposide With or Without All-Trans Retinoic Acid in Older Patients Not Eligible for Intensive Chemotherapy With Acute Myeloid Leukemia and NPM1 Mutation
Lead Sponsor:
University of Ulm
Collaborating Sponsors:
German Federal Ministry of Education and Research
Conditions:
Acute Myeloid Leukemia (AML)
Eligibility:
All Genders
61+ years
Phase:
PHASE3
Brief Summary
This is a randomized, Phase-III, two-arm, open-label, multi-center study in adult patients with AML and NPM1 mutation ineligible for intensive chemotherapy. Sample size: 144 patients Investigator's ...
Eligibility Criteria
Inclusion
- Patients with confirmed diagnosis of acute myeloid leukemia according to the World Health Organization (WHO) classification (including de novo AML, t-AML and s-AML)
- Presence of NPM1 mutation as assessed in one of the central AMLSG reference laboratories.
- Age \> 60 years. There is no upper age limit.
- No prior chemotherapy for leukemia except hydroxyurea to control hyperleukocytosis if needed for up to 10 days during the diagnostic screening phase.
- Signed written informed consent
- Men must give their informed consent that they do not father a baby and must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy. (while on therapy and for 3 month after the last dose of chemotherapy)
- WHO performance status ≤ 3
- Patients not eligible for intensive chemotherapy according to at least one of the following criteria
- HCT-CI Score \>2
- Patient's decision
- age ≥ 75 years
Exclusion
- The presence of any of the following will exclude a patient from study enrollment:
- All other AML subtypes, in particular those AML with other recurrent genetic changes (according to WHO 2008):
- AML with t(8;21)(q22;q22); RUNX1-RUNX1T1
- AML with inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11
- AML with t(15;17)(q22;q12); PML-RARA (or other translocations involving RARA)
- AML with t(9;11)(p22;q23); MLLT3-MLL (or other translocations involving MLL)
- AML with t(6;9)(p23;q34); DEK-NUP214
- AML with inv(3)(q21q26.2) or t(3;3)(q21;q26.2); RPN1-EVI1
- No consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician and all other treating physicians about study participation
- Bleeding disorder independent of leukemia
- Uncontrolled infection
- Known positive for HIV, HBV or HCV
- Organ insufficiency (creatinine \>1.5x upper normal serum level; bilirubin, AST or ALP \>2.5x upper normal serum level, not attributable to AML; heart failure NYHA III/IV; severe obstructive or restrictive ventilation disorder)
- Severe neurological or psychiatric disorder interfering with ability of giving an informed consent
- Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2018
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT01237808
Start Date
March 1 2011
End Date
July 13 2018
Last Update
August 1 2018
Active Locations (33)
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1
Ubbo-Emmius Klinik Aurich
Aurich, Germany, 26603
2
Charité Universitätsmedizin Berlin
Berlin, Germany, 13353
3
University Hospital of Bonn
Bonn, Germany, 53111
4
Städtisches Klinikum Braunschweig
Braunschweig, Germany, 38114