A study evaluating venetoclax (ABT-199) in subjects with Chronic Lymphocytic Leukemia (CLL) whose cancer has come back or who had no response to previous cancer treatments including subjects who may be missing part of their chromosome 17 identified as 17p deletion, or TP53 gene mutation; or subjects who did not respond to or did not tolerate treatment with B-cell receptor inhibitors.

Phase 1

• Conditions: Chronic Lymphocytic Leukemia; MedDRA version: 19.0Level: PTClassification code 10008958Term: Chronic lymphocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-003667-11-FR
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-07
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Age = 18 years.
2. Eastern Cooperative Oncology Group (ECOG) performance score of = 2.
3. Subject has relapsed/refractory disease (received at least one 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)
In addition, patients:
• may harbor 17p deletion or TP53 mutation, assessed by a local laboratory in bone marrow or peripheral blood AND / OR
• may have been previously treated with a prior B-cell receptor inhibitor and failed this therapy or are intolerant to this treatment (i.e., toxicity).
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 major bleeding episode within 3 months of Screening
• hemoglobin = 8.0 g/dL

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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

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 clinical trial of medicinal product
• Study Design: Not specified