Pirtobrutinib for Leukemia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
M D Anderson Cancer Center, Houston, TX
Leukemia+2 More
Pirtobrutinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

To learn if the combination of pirtobrutinib (also called LOXO-305), venetoclax, and obinutuzumab is safe and effective when given to patients with chronic lymphocytic leukemia (CLL) or Richter transformation (RT) who have not previously received treatment.

Eligible Conditions

  • Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Leukemia

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: through study completion an average of 1 year.

Year 1
The severity of the adverse events (AEs) will be graded according to the U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Leukemia

Trial Design

1 Treatment Group

Pirtobrutinib plus Venetoclax plus Obinutuzumab (combination)
1 of 1
Experimental Treatment

60 Total Participants · 1 Treatment Group

Primary Treatment: Pirtobrutinib · No Placebo Group · Phase 2

Pirtobrutinib plus Venetoclax plus Obinutuzumab (combination)Experimental Group · 5 Interventions: Valacyclovir, Venetoclax, Allopurinol, Obinutuzumab, Pirtobrutinib · Intervention Types: Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valacyclovir
2008
Completed Phase 4
~2490
Venetoclax
2019
Completed Phase 3
~1670
Allopurinol
1999
Completed Phase 4
~6100
Obinutuzumab
2013
Completed Phase 3
~3200
Pirtobrutinib
2022
Completed Phase 1
~40

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion an average of 1 year.
Closest Location: M D Anderson Cancer Center · Houston, TX
Photo of Houston 1Photo of Houston 2Photo of Houston 3
2003First Recorded Clinical Trial
203 TrialsResearching Leukemia
465 CompletedClinical Trials

Who is running the clinical trial?

Loxo Oncology, Inc.Industry Sponsor
38 Previous Clinical Trials
7,299 Total Patients Enrolled
7 Trials studying Leukemia
2,996 Patients Enrolled for Leukemia
M.D. Anderson Cancer CenterLead Sponsor
2,772 Previous Clinical Trials
1,795,152 Total Patients Enrolled
437 Trials studying Leukemia
32,215 Patients Enrolled for Leukemia
The Leukemia and Lymphoma SocietyOTHER
71 Previous Clinical Trials
15,877 Total Patients Enrolled
36 Trials studying Leukemia
3,436 Patients Enrolled for Leukemia
Nitin Jain, MDPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
1,577 Total Patients Enrolled
1 Trials studying Leukemia
40 Patients Enrolled for Leukemia

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have adequate renal function.
You have been diagnosed with previously untreated or relapsed/refractory CLL/SLL
You are at least 18 years old.
You have an ECOG performance status of 0-2.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.