Acalabrutinib + Obinutuzumab + Chlorambucil for Chronic Lymphocytic Leukemia
(ElevateTN Trial)

Recruiting in Palo Alto (17 mi)

+277 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Acerta Pharma BV

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This Primary objective 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). Secondary objectives: 1) To evaluate the efficacy of obinutuzumab in combination with chlorambucil (Arm A) versus acalabrutinib monotherapy (Arm C) based on IRC assessment of PFS per IWCLL 2008 criteria. 2)To compare obinutuzumab plus chlorambucil (Arm A) versus acalabrutinib plus obinutuzumab (Arm B) and obinutuzumab plus chlorambucil (Arm A) versus acalabrutinib monotherapy (Arm C) in terms of: IRC-assessed objective response rate (ORR); Tine to next treatment (TTNT); Overall Survival (OS)

Eligibility Criteria

This trial is for adults with untreated chronic lymphocytic leukemia (CLL). Participants must be over 18, have a certain level of kidney function, and not have had previous systemic treatments for CLL. They should also meet specific health criteria like a particular white blood cell count and organ function. Women who can become pregnant and men who can father children must use effective contraception.

Inclusion Criteria

I am a man who can father children and agree to use effective birth control.

I am either over 65 years old or between 18 and 65 with specific conditions.

I have been diagnosed with CLL that tests positive for CD20.

+7 more

Exclusion Criteria

I am currently taking warfarin or a similar blood thinner.

Concurrent participation in another therapeutic clinical trial

I have been diagnosed with prolymphocytic leukemia or Richter's syndrome.

+20 more

Participant Groups

The study compares the effectiveness of two treatment combinations: obinutuzumab with chlorambucil versus acalabrutinib with obinutuzumab, as well as acalabrutinib alone in treating CLL. It looks at how long patients live without their disease getting worse, overall response rate to treatment, time until next treatment is needed, and overall survival rates.

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm C - Acalabrutinib MonotherapyExperimental Treatment1 Intervention

Acalabrutinib (ACP-196) will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity.

Group II: Arm B - Acalabrutinib in Combination with ObinutuzumabExperimental Treatment2 Interventions

Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles starting at Cycle 2 Day 1. Acalabrutinib (ACP-196) will be orally administered starting on Cycle 1 Day 1. Daily administration of Acalabrutinib (ACP-196) will continue until disease progression or unacceptable toxicity.

Group III: Arm A - Obinutuzumab in Combination with ChlorambucilActive Control2 Interventions

Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles starting at Cycle 1 Day 1. Chlorambucil will be orally administered on Days 1 and 15 of Cycles 1 through 6.

Acalabrutinib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Calquence for: