A Study of Venetoclax and Rituximab/Hyaluronidase Human in Relapsed/Refractory CLL (NCT03467867) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Venetoclax and Rituximab/Hyaluronidase Human in Relapsed/Refractory CLL
United States25 participantsStarted 2018-04-26
Plain-language summary
This is an open-label, multicenter, Phase II study to investigate the efficacy and safety of venetoclax in combination with Rituximab/hyaluronidase human in participants with relapsed or refractory chronic lymphocytic leukemia (CLL).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Signed Informed Consent Form
* Ability and willingness to comply with the requirements of the study protocol
* Patient must have diagnosis of CLL that meets published 2008 IWCLL NCI-WG criteria.
* Patient must have relapsed/refractory disease with an indication for treatment.
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2
* Adequate hematologic function (unless caused by underlying disease, as established by extensive bone marrow involvement or as a result of hypersplenism secondary to the involvement of the spleen by lymphoma per the investigator) defined as follows:
* Hemoglobin (\> / =) 9 g/dL
* Absolute neutrophil count (\> / =) 1.0 x 109/L
* Platelet count (\> / =)75 x 109/L
* Adequate renal function, as indicated by:
* Calculated creatinine clearance ≥ 30 mL/min using 24-hour Creatinine Clearance or modified Cockcroft-Gault equation (eCCR; with the use of ideal body mass \[IBM\] instead of mass)
* Adequate liver function, as indicated by:
* AST or ALT (\< / =) 2.5 x ULN
* Total bilirubin \< 1.5 x ULN (or (\< / =) 3 x ULN for patients with documented Gilbert syndrome)
* Female patients who are not of child-bearing potential and female patients of child-bearing potential who have a negative serum pregnancy test within 3 days prior to Cycle 1, Day 1.
* Patients with HIV infection could be included in the study, as long as their disease is under control on anti-retroviral therapy. Precautions s…
What they're measuring
1
Overall Response Rate (ORR)
Timeframe: Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)