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New treatment option for Leukemia
Official title Time-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With Treatment-naïve Chronic Lymphocytic Leukemia (CLL) or Richter Transformation (RT)
ClinicalTrials.gov ID: NCT05536349
What this study is testing
What is Pirtobrutinib?
Pirtobrutinib is an investigational medicine, being studied as a potential treatment for leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with a diagnosis of previously untreated CLL/SLL meeting iwCLL 2018 indication for treatment (cohort 1) or with a diagnosis of previously...
- At least 18 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2
- Adequate hepatic function
- Total bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN for patients with Gilbert's disease or documented disease involvement of liver (In pts...
You likely can't join if
- Major surgery within 4 weeks prior to the first dose of study drugs
- Uncontrolled active systemic infection
- Known positive serology for human immunodeficiency virus (HIV)
- Active hepatitis B infection (defined as the presence of detectable HBV DNA, HBe antigen or HBs antigen). Patients with serologic evidence of prior...
- Active hepatitis C infection (defined as detectable hepatitis C RNA in plasma by PCR)
- Known active cytomegalovirus (CMV) infection. Unknown or negative status are eligible
See the full eligibility criteria
- Patients with a diagnosis of previously untreated CLL/SLL meeting iwCLL 2018 indication for treatment (cohort 1) or with a diagnosis of previously untreated or relapsed/refractory RT arising from CLL (cohort 2)...
- At least 18 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2
- Adequate hepatic function
- Total bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN for patients with Gilbert's disease or documented disease involvement of liver (In pts with elevated total bilirubin due to increased indirect bilirubin...
- ALT and AST ≤3.0 x ULN, or ≤5.0 x ULN if documented disease involvement of liver
- Adequate renal function a. Creatinine clearance ≥ 50 ml/min (calculated using CKD-EPI formula)
- Adequate hematologic function a. Platelet count ≥50 x109/L and hemoglobin ≥ 8 g/dL (≥ 80 g/L). Platelet and hemoglobin requirements are independent of transfusions within 7 days of screening assessment and first dose of...
- Ability to swallow tablets and comply with outpatient treatment, laboratory monitoring, and required clinic visit for the duration of study participation
- Women of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (β-hCG) pregnancy test result within 7 days prior to the first dose of study drugs and must agree to use an effective...
- Major surgery within 4 weeks prior to the first dose of study drugs
- Uncontrolled active systemic infection
- Known positive serology for human immunodeficiency virus (HIV)
- Active hepatitis B infection (defined as the presence of detectable HBV DNA, HBe antigen or HBs antigen). Patients with serologic evidence of prior vaccination (HBsAg negative, anti-HBs antibody positive, anti-HBc...
- Active hepatitis C infection (defined as detectable hepatitis C RNA in plasma by PCR)
- Known active cytomegalovirus (CMV) infection. Unknown or negative status are eligible
- Active, uncontrolled autoimmune phenomenon (autoimmune hemolytic anemia or immune thrombocytopenia) requiring steroid therapy with \> 20 mg daily of prednisone or equivalent or for which new therapy was introduced or...
- Clinically significant, uncontrolled cardiovascular disease (≥3 NYHA heart failure, uncontrolled or symptomatic arrythmias), or myocardial infarction within 6 months, or stroke within 6 months, or intracranial bleeding...
- Prolongation of the QT interval corrected for heart rate (QTcF) \> 470 msec. Note: Patients with QTcF \> 470 msec should have EKG repeated. If QTcF again is \> 470 msec, then the patient should be referred to cardiology...
- Pregnancy, lactation or plan to breastfeed during the study or within 6 months of the last dose of study treatment
- Concurrent use of warfarin or another vitamin K antagonist
- Current treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers. A washout period of at least 5 half-lives of these agents following discontinuation and prior to study entry is required (treatment with...
- Active graft versus host disease (GVHD)
- Cytopenia from incomplete blood cell count recovery post-transplant
- Need for anti-cytokine therapy for toxicity from CAR-T therapy or residual symptoms of neurotoxicity \> Grade 1 from CAR-T therapy
- Ongoing immunosuppressive therapy (\> 20 mg prednisone or equivalent daily) including GVHD prophylaxis/treatment (calcineurin inhibitors or ruxolitinib) iii. Patients are required to have the following washout periods...
- Immunoconjugated antibody treatment within 10 weeks prior to randomization
- Broad field radiation (≥ 30% of the bone marrow or whole brain radiotherapy) must be completed 14 days prior to study enrollment
- Palliative limited field radiation must be completed 7 days prior to study enrollment. iv. Prior therapy with venetoclax and obinutuzumab is allowed but Richter should not have developed while actively receiving...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.