Description:
This study is evaluating the efficacy of obinutuzumab in combination with chlorambucil (Arm
A) compared with acalabrutinib in combination with obinutuzumab (Arm B) for the treatment of
previously untreated chronic lymphocytic leukemia (CLL).
Title
- Brief Title: Elevate CLL TN: Study of Obinutuzumab + Chlorambucil, Acalabrutinib (ACP-196) + Obinutuzumab, and Acalabrutinib in Subjects With Previously Untreated CLL
- Official Title: A Randomized, Multicenter, Open-Label, 3 Arm Phase 3 Study of Obinutuzumab in Combination With Chlorambucil, Acalabrutinib (ACP-196) in Combination With Obinutuzumab, and Acalabrutinib Monotherapy in Subjects With Previously Untreated CLL
Clinical Trial IDs
- ORG STUDY ID:
ACE-CL-007
- NCT ID:
NCT02475681
Conditions
- Chronic Lymphocytic Leukemia
Interventions
Drug | Synonyms | Arms |
---|
Acalabrutinib | | Acalabrutinib Monotherapy |
Obinutuzumab | | Acalabrutinib in Combination with Obinutuzumab |
Chlorambucil | | Obinutuzumab in Combination with Chlorambucil |
Purpose
This study is evaluating the efficacy of obinutuzumab in combination with chlorambucil (Arm
A) compared with acalabrutinib in combination with obinutuzumab (Arm B) for the treatment of
previously untreated chronic lymphocytic leukemia (CLL).
Trial Arms
Name | Type | Description | Interventions |
---|
Obinutuzumab in Combination with Chlorambucil | Active Comparator | Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles. Chlorambucil will be orally administered on Days 1 and 15 of Cycles 1 through 6. | |
Acalabrutinib in Combination with Obinutuzumab | Experimental | Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles. ACP-196 will be orally administered starting on Cycle 1 Day 1. Daily administration of ACP-196 will continue until disease progression or unacceptable toxicity. | - Acalabrutinib
- Obinutuzumab
|
Acalabrutinib Monotherapy | Experimental | Acalabrutinib will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity. | |
Eligibility Criteria
Inclusion Criteria:
- Men and women: ≥ 65 years of age OR > 18 and < 65 years of age, provided that they
meet at least one of the following criteria:
1. Creatinine clearance 30 to 69 mL/min.
2. A score higher than 6 on the Cumulative Illness Rating Scale-Geriatric.
- ECOG performance status of 0, 1, or 2.
- Diagnosis of CD20+ CLL.
- Active disease meeting ≥ 1 of the following IWCLL 2008 criteria for requiring
treatment.
- Meet the following laboratory parameters:
1. ANC ≥ 750 cells/μL, or ≥ 500 cells/μL in subjects with documented bone marrow
involvement, and independent of growth factor support 7 days before assessment.
2. Platelet count ≥ 50,000 cells/μL, or ≥ 30,000 cells/μL in subjects with
documented bone marrow involvement, and without transfusion support 7 days before
assessment. Subjects with transfusion-dependent thrombocytopenia are excluded.
3. Serum AST and ALT/SGPT ≤ 3.0 x ULN.
4. Total bilirubin ≤ 1.5 x ULN.
5. Estimated creatinine clearance ≥ 30 mL/min.
Exclusion Criteria:
- Any prior systemic treatment for CLL.
- Known CNS lymphoma or leukemia.
- Known prolymphocytic leukemia or history of, or currently suspected, Richter's
syndrome.
- Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.
- Major surgery within 4 weeks before first dose of study drug.
- Prior malignancy, except for adequately treated lentigo maligna melanoma,
non-melanomatous skin cancer, in situ cervical carcinoma, or other malignancy treated
with no evidence of active disease > 3 years before Screening and at low risk for
recurrence.
- Significant cardiovascular disease within 6 months of screening.
- Known history of infection with HIV.
- History of stroke or intracranial hemorrhage within 6 months before randomization.
- Known history of a bleeding diathesis.
- Requires or receiving anticoagulation with warfarin or equivalent vitamin K
antagonists within 7 days of first dose of study drug.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression-free survival in Arm A compared to Arm B |
Time Frame: | 49 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | IRC-assessed objective response rate (ORR) in Arm A versus Arm B and Arm A versus Arm C |
Time Frame: | 49 months |
Safety Issue: | |
Description: | |
Measure: | Time to next treatment (TTNT) in Arm A versus Arm B and Arm A versus Arm C |
Time Frame: | 49 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of adverse events, serious adverse events and changes in laboratory measurements in Arm A versus Arm B and Arm A versus Arm C |
Time Frame: | 49 months |
Safety Issue: | |
Description: | |
Measure: | Overall survival in Arm A versus Arm B and Arm A versus Arm C |
Time Frame: | 49 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Acerta Pharma BV |
Last Updated
October 14, 2019