Asciminib + Inotuzumab Ozogamicin for Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a multi-center phase 1 open-label study to determine the safety of ABL001 and INO in patients with relapsed or refractory Philadelphia chromosome-positive b-cell acute lymphoblastic leukemia.
Who Is on the Research Team?
Sunil Iyer, MD
Principal Investigator
Columbia University
Are You a Good Fit for This Trial?
This trial is for people with Philadelphia chromosome-positive B-cell acute lymphoblastic leukemia (Ph+ B-ALL) that has come back or not responded to treatment. Participants should be adults whose cancer fits these criteria.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Asciminib
- Inotuzumab ozogamicin
Trial Overview
The study is testing the safety of two drugs, Asciminib and Inotuzumab ozogamicin, given together in patients with relapsed or hard-to-treat Ph+ B-ALL. It is an early-phase, open-label trial at multiple centers.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All participants enrolled to the treatment arm of the study will receive Asciminib in combination with Inotuzumab Ozogamicin. INO is to be dosed in a fractionated schedule as follows: * Prior to achieving compositive complete remission (CRc): 0.8 mg/m2 day 1, 0.5 mg/m2 days 8 and 15 * Once CRc achieved (even if MR3/MR4 not achieved): 0.5 mg/m2 days 1, 8, 15 Asciminib will be administered at a dose of 40, 60, 80, 160, or 200 mg twice daily.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sunil G. Iyer
Lead Sponsor
Novartis
Industry Sponsor
Vasant Narasimhan
Novartis
Chief Executive Officer since 2018
MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government
Shreeram Aradhye
Novartis
Chief Medical Officer since 2022
MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania
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