A Phase 1/2 Study of ABT-199 in Combination with Low-Dose Cytarabine in Treatment-Naïve Subjects with Acute Myelogenous Leukemia Who Are = 65 Years of Age and Who Are Not Eligible for Standard Anthracycline-Based Induction Therapy
- Conditions
- Acute Myelogenous LeukemiaMedDRA version: 17.0Level: LLTClassification code 10001941Term: AMLSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-002610-23-IT
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 67
1. Subject must be = 65 years of age.
2. Subject must have a projected life expectancy of at least 12 weeks.
3. Subject must have histological confirmation of AML and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to co-morbidity or other factors.
4. Subject must have received no prior treatment for AML with the exception of hydroxyurea, allowed through first cycle of treatment. NOTE: Subject may have been treated for prior Myelodysplastic Syndrome.
5. Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2.
6. Subject must have adequate renal function as demonstrated by a calculated creatinine clearance = 50 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula.
7. Subject must have adequate liver function as demonstrated by: aspartate aminotransferase (AST) = 2.5 × ULN*, alanine aminotransferase (ALT) = 2.5 × ULN*, bilirubin = 1.5 × ULN*, Unless considered due to leukemic organ involvement.
Note: Subjects with Gilbert's Syndrome may have a bilirubin > 1.5 × ULN per discussion between the investigator and AbbVie medical monitor.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 67
1. Subject has received treatment with cytarabine for a pre-existing myeloid disorder.
2. Subject has acute promyelocytic leukemia .
3. Subject has known active CNS involvement with AML.
4. Subject has tested positive for HIV (due to potential drug-drug interactions between antiretroviral medications and ABT-199, as well as anticipated ABT-199 mechanism-based lymphopenia that may potentially increase the risk of opportunistic infections). Note: HIV testing is not required.
5. Subject has received the following within 7 days prior to the initiation of study treatment:
• Potent CYP3A inducers such as rifampin, carbamazepine, phenytoin, and St. John's Wort;
• Warfarin or requires the use of warfarin (due to potential drug-drug interactions that may potentially increase the exposure of warfarin and complications of this effect).
6. Subject has received the following within 5 days prior to the initiation of study treatment:
• CYP3A inhibitors such as fluconazole, ketoconazole, and clarithromycin.
7. Subject has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Starfruit within 3 days prior to the initiation of study treatment.
8. Subject has a cardiovascular disability status of New York Heart Association Class = 2. Class 2 is defined as cardiac disease in which subjects are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or anginal pain.
9. Subject has a white blood cell count > 25 × 109/L. Note: Hydroxyurea is permitted to meet this criterion.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method