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Completed
NCT03534323
Duvelisib and Venetoclax in Relapsed or Refractory CLL or SLL or RS
Conditions: Chronic Lymphocytic Leukemia, Richter Syndrome
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 55
Sponsor: Dana-Farber Cancer Institute
Location: University of Miami- Sylvester Comprehensive Cancer Center Miami Florida
Summary
This research study is assessing a new drug, duvelisib, in combination with a drug that is already FDA approved, venetoclax, as a possible treatment for participants with CLL or those with Richter's Syndrome
Eligibility Criteria
Inclusion Criteria:
* Must have a confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma requiring therapy, as per IW-CLL 2008 criteria OR Biopsy proven transformation to diffuse large B cell lymphoma (DLBCL), consistent with Richter's Syndrome
* Disease that has progressed during or relapsed after at least one previous CLL/SLL therapy - If Richter's Syndrome, this criterion is not applicable
* Age greater to or equal to 18 years
* ECOG performance status ≤2 (Karnofsky ≥60%)
* Patients must meet the following hematologic criteria at screening, unless they have significant bone marrow involvement of CLL confirmed on biopsy:
* Absolute neutrophil count ≥500 cells/mm3 (0.5 x 109/L). Growth factor is allowed in order to achieve this
* Platelet count ≥25,000 cells/mm3 (25 x 109/L) independent of transfusion within 7 days of screening
* Adequate hepatic function defined as:
--Serum aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x upper limit of normal (ULN), bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
* Adequate renal function as defined as:
--Serum creatinine ≤1.5 times the upper limit of normal or creatinine clearance ≥ 50 mL/min using a 24-hour urine collection
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal, barrier method or abstinence) prior to study entry and for the duration of study participation
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Previous treatment with venetoclax or duvelisib
* Patients receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, surgery within 2 weeks of Cycle 1/Day 1 with the following exceptions:
* For patients on targeted therapies, a washout of least five half lives is required
* Patients who experience clinical deterioration may start therapy after a shorter washout period with prior approval by the PI
* Corticosteroid therapy (prednisone or equivalent \
Source: ClinicalTrials.gov (NCT03534323). StuddyBuddy aggregates publicly available trial information.