🏛️ Verified NIH Record • Updated 2026-08-07

Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL (NCT02475681)

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

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Acerta Pharma BV

🩺 Plain-English Summary (8th-Grade Level)

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)

Who can join: Review the eligibility criteria below.

Location: Research Site — Goodyear, Arizona

Age range: 18 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (155 Sites)

Showing the first 25 of 155 sites.

  • Research Site — Goodyear, Arizona
  • Research Site — Phoenix, Arizona
  • Research Site — Anaheim, California
  • Research Site — Los Angeles, California
  • Research Site — Los Angeles, California
  • Research Site — Los Angeles, California
  • Research Site — Oxnard, California
  • Research Site — Palo Alto, California
  • Research Site — Aurora, Colorado
  • Research Site — Lone Tree, Colorado
  • Research Site — Washington D.C., District of Columbia
  • Research Site — Fort Myers, Florida
  • Research Site — Jacksonville, Florida
  • Research Site — Tallahassee, Florida
  • Research Site — Tallahassee, Florida
  • Research Site — Tampa, Florida
  • Research Site — Niles, Illinois
  • Research Site — Lafayette, Indiana
  • Research Site — Wichita, Kansas
  • Research Site — Louisville, Kentucky
  • Research Site — New Orleans, Louisiana
  • Research Site — COL, Maryland
  • Research Site — Rochester, Minnesota
  • Research Site — Saint Cloud, Minnesota
  • Research Site — Billings, Montana

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗