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Monoclonal Antibodies

Triple Therapy for Chronic Lymphocytic Leukemia

Phase 2
Recruiting
Led By Nitin Jain, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a combination of pirtobrutinib, venetoclax, and obinutuzumab is safe and effective for patients with CLL or RT who haven't had previous treatment.

Who is the study for?
This trial is for adults with untreated chronic lymphocytic leukemia (CLL) or Richter transformation (RT). Participants must have certain levels of bilirubin, renal function, and blood counts. They should not have active hepatitis B/C, HIV, uncontrolled infections or autoimmune diseases requiring high-dose steroids. Pregnant women are excluded and participants must agree to use effective contraception.
What is being tested?
The study tests a combination of three drugs: Pirtobrutinib, Venetoclax, and Obinutuzumab in patients who haven't been treated before for CLL or RT. It aims to determine the safety and effectiveness of this drug regimen.
What are the potential side effects?
Potential side effects may include reactions at the infusion site from Obinutuzumab; diarrhea, nausea from Venetoclax; bleeding risks from Pirtobrutinib; as well as general side effects like fatigue and increased risk of infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2022 Phase 1 trial • 32 Patients • NCT05176314
9%
Petechiae
3%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
200 mg Pirtobrutinib QD (Days 7-12)
20 mg Rosuvastatin (Day 1)
200 mg Pirtobrutinib QD (Days 14-17)
20 mg Rosuvastatin + 200 mg Pirtobrutinib (Day 13)
20 mg Rosuvastatin + 200 mg Pirtobrutinib (Day 6)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pirtobrutinib plus Venetoclax plus Obinutuzumab (combination)Experimental Treatment5 Interventions
Participants will receive the study drugs in cycles. Each cycle is 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pirtobrutinib
2020
Completed Phase 1
~240
Obinutuzumab
2014
Completed Phase 3
~3470
Venetoclax
2019
Completed Phase 3
~2240
Valacyclovir
2008
Completed Phase 4
~2520
Allopurinol
1999
Completed Phase 4
~6150

Find a Location

Who is running the clinical trial?

The Leukemia and Lymphoma SocietyOTHER
85 Previous Clinical Trials
26,234 Total Patients Enrolled
42 Trials studying Leukemia
12,961 Patients Enrolled for Leukemia
M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,586 Total Patients Enrolled
464 Trials studying Leukemia
31,715 Patients Enrolled for Leukemia
Loxo Oncology, Inc.Industry Sponsor
71 Previous Clinical Trials
11,000 Total Patients Enrolled
9 Trials studying Leukemia
3,266 Patients Enrolled for Leukemia

Media Library

Obinutuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05536349 — Phase 2
Leukemia Research Study Groups: Pirtobrutinib plus Venetoclax plus Obinutuzumab (combination)
Leukemia Clinical Trial 2023: Obinutuzumab Highlights & Side Effects. Trial Name: NCT05536349 — Phase 2
Obinutuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05536349 — Phase 2
~11 spots leftby Apr 2025
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