Open-Label, Single Arm, Phase 3b, Multi-Center Study Evaluating the Efficacy of Venetoclax (ABT-199) in Relapsed/Refractory Subjects with Chronic Lymphocytic Leukemia (CLL)
- Conditions
- LeukemiaCancer of the blood10024324
- Registration Number
- NL-OMON55465
- Lead Sponsor
- AbbVie B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
1. Age >= 18 years., 2. Eastern Cooperative Oncology Group (ECOG) performance
score of <= 2., 3. Subject has relapsed/refractory disease (received at least
one line of prior therapy). , 4. Diagnosis of CLL that meets published 2008
Modified International Workshop on CLL National Cancer Institute - Working
Group (IWCLL NCI-WG) Guidelines and:
• has an indication for treatment according to the 2008 Modified IWCLL NCI-WG
Guidelines
• has clinically measurable disease (lymphocytosis > 5 × 10^9/L and/or palpable
and measurable nodes by physical exam and/or organomegaly assessed by physical
exam)
• subjects with or without the 17p deletion or TP53 mutation are eligible
• subjects who have received prior B-cell receptor inhibitor therapy are also
eligible (up to 60 subjects total will be enrolled in the study), 5. Adequate
bone marrow function as follows:
• platelets >= 25,000/mm^3 without any of the following:
o transfusion support within 14 days of Screening
o evidence of mucosal bleeding
o known history of bleeding episode within 3 months of Screening
• hemoglobin >= 8.0 g/dL
1. Subject has developed Richter's transformation or Prolymphocytic leukemia
(PLL), 2. Subject has previously received venetoclax., 3. History of active
malignancies other than CLL within the past 2 years prior to first dose of
venetoclax, with the exception of:
• adequately treated in situ carcinoma of the cervix uteri
• adequately treated basal cell carcinoma or localized squamous cell carcinoma
of the skin
• previous malignancy confined and surgically resected (or treated with other
modalities) with curative intent., 4. Active and uncontrolled autoimmune
cytopenias (within 2 weeks prior to Screening), including autoimmune hemolytic
anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP), despite low dose
corticosteroids., 5. Prior allogeneic stem cell transplant.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy endpoint will be measured by complete remission rate (CR +<br /><br>CRi) of the subjects who have not been previously treated with BCRi therapy as<br /><br>assessed by the investigator.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Key secondary efficacy endpoints:<br /><br>Overall response rate, duration of response, time to progression,<br /><br>progression-free survival, overall survival, complete remission rate in B-cel<br /><br>receptor inhibitor treated subjects.</p><br>