A Study of the Efficacy of ABT-199 (GDC-0199) in Subjects withRelapsed/Refractory or previously untreated Chronic LymphocyticLeukemia with the 17p Deletio
- Conditions
- Chronic Lymphocytic Leukemia 17 p DeletionMedDRA version: 20.0Level: LLTClassification code 10024340Term: Leukemia lymphocytic chronicSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-004027-20-PL
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
1. Subject must be = 18 years of age
2. Subject must have diagnosis of CLL that meets published 2008 Modified IWCLL NCI-WG Guidelines.
• Subject has an indication for treatment according to the 2008 Modified IWCLL NCI-WG Guidelines.
• Subject has clinically measurable disease;
? Subject must have relapsed/refractory CLL or previously untreated CLL;
? Refractory or relapsed CLL subjects must meet the following
requirements:
? Refractory or relapsed after receiving at least one prior line of therapy (subjects that have progressed after 1 cycle of treatment or have completed at least 2 cycles of treatment for a given line of therapy);
? Previously untreated CLL subjects must meet the following
requirements (previously untreated chronic lymphocytic leukemia harboring 17p deletion patients will not be enrolled in Germany):
? Received no prior chemotherapy or immunotherapy. Subjects with a history of emergency, loco-regional radiotherapy (e.g., for relief of compressive signs or symptoms) are eligible.
? CLL diagnostic criteria above and must have > 5 × 109/L
B-Lymphocytes in the peripheral blood.
• Subjects must have 17p deletion, assessed by local laboratory (in bone
marrow or peripheral blood) or assessed by central laboratory
(peripheral blood).
3. Subject has an ECOG performance score of = 2
4. Subjects must meet the following laboratory parameters, per
laboratory reference range:
- ANC = 1000/µL
For subjects with an ANC < 1000/µL at Screening and bone marrow heavily infiltrated with underlying disease (unless cytopenia is clearly due to marrow involvement of CLL), growth factor support may be administered after Screening and prior to the first dose of venetoclax to achieve the ANC eligibility criteria (= 1000/µL);
- Platelets = 30,000/mm3
- Hemoglobin = 8.0 g/dL;
- aPTT and PT = 1.5 × ULN;
- Calculated creatinine clearance> 50 mL/min;
- AST and ALT = 3 × ULN;
- Total bilirubin = 1.5 × ULN (Subjects with Gilbert's Syndrome may have bilirubin > 1.5 × ULN per correspondence between the nvestigator and AbbVie medical monitor).
5. For high risk subjects (as defined in Section 6.7.1) a pre approval by the AbbVie medical monitor is required prior to enrollment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
1-Subject has undergone an allogeneic stem cell transplant
2-Subjects has developed Richter's transformation confirmed by biopsy.
3-Subject has prolymphocytic leukemia.
4-Subject has active and uncontrolled autoimmune cytopenias (for 2 weeks prior to Screening), including autoimmune hemolytic anemia (AIHA) and idiopathic thrombocytopenic purpura (ITP) despite low dose corticosteroids.
5-Subject is known to be positive for HIV, due to potential drug-drug interactions as well as anticipated mechanism-based lymphopenia that may increase the risk of opportunistic infections).
6-Subject has received the following within 30 days prior to the first dose of study drug:
?A biologic agent (i.e., monoclonal antibodies) for anti-neoplastic intent.
7-Subject has received radiotherapy within 14 days or any of the following within 5 half-lives as applicable prior to the first dose of study drug, or has not recovered to less than CTC grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy:
?Any anti-cancer therapy including chemotherapy, or radiotherapy;
?Investigational therapy, including targeted small molecule agents.
8-Subject has known allergy to both xanthine oxidase inhibitors and rasburicase.
9-Cardiovascular disability status of New York Heart Association Class = 2.
10- Subjects exhibits evidence of other clinically significant uncontrolled condition(s), including, but not limited to:
- Uncontrolled and/or active systemic infection (viral, bacterial, or fungal).
- Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment.
- Febrile neutropenia
11-Subject has a significant history of renal, pulmonary, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study. For subjects who have required an intervention for any above diseases within the past 6 months correspondence with the investigator and the AbbVie medical monitor must occur.
12-Subject has a significant history of other active malignancies other than CLL within the past 3 years prior to study entry, with the following exceptions: Adequately treated in situ carcinoma of the cervix uteri;
Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
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