A Study to Evaluate the Efficacy of Venetoclax in Relapsed/Refractory Participants With Chronic Lymphocytic Leukemia (CLL) Including Those With 17p Deletion or TP53 Mutation or Those Who Have Received a Prior B-cell Receptor Inhibitor.
Status: | Active, not recruiting |
---|---|
Conditions: | Blood Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 12/20/2018 |
Start Date: | June 22, 2016 |
End Date: | March 5, 2022 |
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)
The purpose of this open-label, single-arm study is to evaluate the efficacy of venetoclax
monotherapy in approximately 250 participants with relapsed/refractory CLL including those
with the 17p deletion or TP53 mutation (assessed by local lab) OR those who have received
prior treatment with a B-cell receptor inhibitor. The starting dose of venetoclax is 20 mg
once daily. The dose must be gradually increased over a period of 5 weeks up to the daily
dose of 400 mg. Participants may continue receiving venetoclax for up to 2 years. After the
treatment period, participants may continue on into a 2-year follow-up period.
monotherapy in approximately 250 participants with relapsed/refractory CLL including those
with the 17p deletion or TP53 mutation (assessed by local lab) OR those who have received
prior treatment with a B-cell receptor inhibitor. The starting dose of venetoclax is 20 mg
once daily. The dose must be gradually increased over a period of 5 weeks up to the daily
dose of 400 mg. Participants may continue receiving venetoclax for up to 2 years. After the
treatment period, participants may continue on into a 2-year follow-up period.
Inclusion Criteria:
- Participant has Eastern Cooperative Oncology Group (ECOG) performance score of less
than or equal to 2
- Participant has relapsed/refractory disease (received at least 1 prior therapy)
- Participant has diagnosis of CLL that meets published 2008 Modified IWCLL NCI-WG
Guidelines and:
- has an indication for treatment according to the 2008 Modified IWCLL NCI-WG
criteria
- has clinically measurable disease (lymphocytosis greater than 5 × 109/L and/or
palpable and measurable nodes by physical exam and/or organomegaly assessed by
physical exam)
- In addition, participants:
- with or without 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
- Participant must have adequate bone marrow function, coagulation profile, renal, and
hepatic function, per laboratory reference range at Screening
Exclusion Criteria:
- Participant has developed Richter's transformation or Prolymphocytic leukemia
- Participant has previously received venetoclax
- 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
- Participant has active and uncontrolled autoimmune cytopenias (for 2 weeks prior to
Screening), including autoimmune hemolytic anemia and idiopathic thrombocytopenic
purpura despite low dose corticosteroids
- Participant has undergone an allogeneic stem cell transplant grade 2:
- Any anti-cancer therapy including chemotherapy, or radiotherapy;
- Investigational therapy, including targeted small molecule agents
- Participant is human immunodeficiency virus (HIV) positive
- Participant has known allergy to both xanthine oxidase inhibitors and rasburicase
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