Elevate CLL TN: Study of Obinutuzumab + Chlorambucil, Acalabrutinib (ACP-196) + Obinutuzumab, and Acalabrutinib in Subjects With Previously Untreated CLL
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|ClinicalTrials.gov Identifier: NCT02475681|
Recruitment Status : Active, not recruiting
First Posted : June 19, 2015
Last Update Posted : May 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia||Drug: Acalabrutinib Drug: Obinutuzumab Drug: Chlorambucil||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||535 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||December 2019|
Active Comparator: Obinutuzumab in Combination with Chlorambucil
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.
|Drug: Obinutuzumab Drug: Chlorambucil|
Experimental: Acalabrutinib in Combination with Obinutuzumab
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.
|Drug: Acalabrutinib Drug: Obinutuzumab|
Experimental: Acalabrutinib Monotherapy
Acalabrutinib will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity.
- Progression-free survival in Arm A compared to Arm B [ Time Frame: 49 months ]
- IRC-assessed objective response rate (ORR) in Arm A versus Arm B and Arm A versus Arm C [ Time Frame: 49 months ]
- Time to next treatment (TTNT) in Arm A versus Arm B and Arm A versus Arm C [ Time Frame: 49 months ]
- 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 ]
- Overall survival in Arm A versus Arm B and Arm A versus Arm C [ Time Frame: 49 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475681
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|Study Director:||Prista Charuworn, MD||Acerta Pharma BV|