๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-06-29

Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia (NCT04994717)

Phase 3 Randomized, Controlled Study of Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia With Safety Run-in (Golden Gate Study)

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Amgen

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The safety run-in part of the study aims to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy. The phase 3 part of the study aims to compare event-free survival (EFS) and overall survival (OS) of participants receiving blinatumomab alternating with low-intensity chemotherapy to EFS and (OS) of participants receiving standard of care (SOC) chemotherapy.

Who can join: Review the eligibility criteria below.

Location: City of Hope National Medical Center โ€” Duarte, California

Age range: 40 Years to 100 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (192 Sites)

Showing the first 25 of 192 sites.

  • City of Hope National Medical Center โ€” Duarte, California
  • University of California Irvine โ€” Orange, California
  • University of California San Francisco โ€” San Francisco, California
  • Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando โ€” Orlando, Florida
  • Cleveland Clinic Foundation โ€” Cleveland, Ohio
  • Saint Francis Hospital, Inc โ€” Greenville, South Carolina
  • University of Texas MD Anderson Cancer Center โ€” Houston, Texas
  • Canberra Hospital โ€” Garran, Australian Capital Territory
  • Royal Prince Alfred Hospital โ€” Camperdown, New South Wales
  • Liverpool Hospital โ€” Liverpool, New South Wales
  • Royal North Shore Hospital โ€” St Leonards, New South Wales
  • Westmead Hospital โ€” Westmead, New South Wales
  • Royal Brisbane and Womens Hospital โ€” Herston, Queensland
  • Princess Alexandra Hospital โ€” Woolloongabba, Queensland
  • Royal Adelaide Hospital โ€” Adelaide, South Australia
  • Monash Medical Centre โ€” Clayton, Victoria
  • Austin Health, Austin Hospital โ€” Heidelberg, Victoria
  • Peter MacCallum Cancer Centre โ€” Melbourne, Victoria
  • The Alfred Hospital โ€” Melbourne, Victoria
  • Fiona Stanley Hospital โ€” Murdoch, Western Australia
  • Medizinische Universitaet Graz โ€” Graz,
  • Medizinische Universitaet Innsbruck โ€” Innsbruck,
  • Ordensklinikum Linz Elisabethinen โ€” Linz,
  • Hanusch Krankenhaus โ€” Vienna,
  • Institut Jules Bordet โ€” Anderlecht,

๐Ÿ“ž Contact the Study Coordinator

Phone: (800) 826-4673

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ 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 ยง 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  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.
๐Ÿ›๏ธ View Official NIH Record โ†—