Status:
COMPLETED
Study of Decitabine Alone or in Combination With Valproic Acid and All-trans Retinoic Acid in Acute Myeloid Leukemia
Lead Sponsor:
University Hospital Freiburg
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
AML of the older patient constitutes a major unmet clinical need since the large majority will not be found eligible for induction chemotherapy. Reasons for this decision include host factors (comorbi...
Detailed Description
By employing a 2x2 factorial design, this phase II study will address the possible added efficacy of addition of one or even both of these agents to low-dose Decitabine. The primary endpoint of this s...
Eligibility Criteria
Inclusion
- Written informed consent obtained according to international guidelines and local law;
- Male or female patients aged \> 60 years without upper age limit;
- Patients with primary or secondary AML according to WHO (≥ 20% blasts in the peripheral blood (pB) or bone marrow (BM)) who are not expected to benefit from standard remission-induction chemotherapy;
- Patients with \< 30 000 leukocytes/μl;
- Performance status ECOG 0, 1, 2;
- Creatinine \< 2.0 mg/dl (unless leukemia-related);
- Ability to understand the nature of the study and the study related procedures and to comply with them.
Exclusion
- AML of FAB subtype M3;
- Previous remission-induction chemotherapy for MDS or AML, previous allografting;
- Previous treatment with DAC, 5-azacytidine, VPA or another HDAC inhibitor, or ATRA;
- "Low-dose" chemotherapy (e.g. hydroxyurea, cytosine arabinoside (Ara-C), melphalan, clofarabine etc.) within 4 weeks prior to DAC treatment, except for cytoreduction of leukocytosis ≥ 30 000/μl with hydroxyurea or Ara-C as proscribed by the study protocol (section 7.3 and 7.4); the patient must have recovered from all clinically relevant reversible non-hematologic toxicities;
- Treatment with tyrosine kinase inhibitors, immunomodulating agents (IMIDS) or other investigational AML treatment within the last 4 weeks or in a time period of drug half-life x 5 (whatever is shorter) before the first administration of DAC;
- Treatment with cytokines within previous 4 weeks;
- Concomitant therapy which is considered relevant for the evaluation of efficacy or safety of the trial drug (i.e. other chemo- or immunotherapy);
- Other malignancy requiring treatment (previous chemotherapy for other malignancies is not an exclusion criteria);
- Cardiac insufficiency NYHA IV;
- Insufficient hepatic function (bilirubin, AST or ALT \> = 2.5 x Upper Limit of Normal (ULN)) (unless leukemia-related);
- Fatal hepatic function disorder during treatment with valproic acid in siblings;
- Hepatic porphyria;
- Manifest serious pancreatic function disorder;
- Plasmatic coagulation disorder not related to AML;
- Known active hepatitis B or C;
- Known HIV infection;
- Other uncontrolled active infections;
- Known allergy against soy beans or peanuts;
- Psychiatric disorder that interferes with treatment;
- Patient without legal capacity who is unable to understand the nature, significance and consequences of the study;
- Known hypersensitivity to, or intolerance of, one of the trial drugs, another retinoid or the excipients of the trial drugs;
- Concomitant use of any other investigational drug or participation in a clinical trial within the last thirty days before the start of this study; simultaneous participation in registry and diagnostic trials is allowed;
- Female patients who are pregnant or breast feeding;
- Fertile patients refusing to use safe contraceptive methods during the study (for details see clinical trial protocol section 5.3);
- Known or persistent abuse of medication, drugs or alcohol.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT00867672
Start Date
August 1 2011
End Date
February 1 2016
Last Update
August 31 2016
Active Locations (27)
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1
Klinikum der Technischen Universität Aachen
Aachen, Germany, 52074
2
Vivantes Klinikum Neukölln
Berlin, Germany, 12351
3
Augusta-Kranken-Anstalt gGmbH
Bochum, Germany, 44791
4
Klinikum Braunschweig
Braunschweig, Germany, 38126