Fixed-duration treatment for chronic lymphocytic leukemia with ibrutinib and obinutuzumab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 multicenter interventional study aims to evaluate the efficacy of a fixed-duration therapy combining ibrutinib and obinutuzumab in treatment-naïve patients with chronic lymphocytic leukemia (CLL). Patients will receive ibrutinib daily for 24 months, with obinutuzumab administered starting from the 13th cycle. The primary endpoint is to assess the undetectable minimal residual disease (uMRD) in the bone marrow at the end of treatment, followed by a 30-day follow-up. If patients experience disease relapse after treatment, ibrutinib will be reintroduced at the standard dose.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years
2. Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that meets iwCLL diagnostic criteria
3. Previously untreated active disease requiring treatment per iwCLL criteria
4. ECOG PS 0 or 1
5. Measurable lymph node disease (\>1.5 cm longest diameter) by CT scan
6. Adequate hematologic function defined as:

   1. Absolute neutrophil count (ANC) \>750 cells/μL (750 cells/mm3 or 0.75 x 109/L)
   2. Platelet count \>30,000/μL (30,000 cells/mm3 or 30 x 109/L)
   3. Hemoglobin \>8.0 g/dL
7. Adequate hepatic and renal function defined as:

   1. Serum aspartate transaminase (AST) or alanine transaminase (ALT) ≤3.0 x upper limit of normal (ULN)
   2. Estimated Creatinine Clearance (CrCl) ≥30 mL/min (Cockcroft- Gault)
   3. Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
8. Prothrombin time (PT)/International normal ratio (INR) \<1.5 x ULN and PTT (activated partial thromboplastin time \[aPTT\]) \<1.5 x ULN (unless abnormalities are unrelated to coagulopathy or bleeding disorder).

Exclusion Criteria:

Any prior therapy (including but not limited to chemotherapy, targeted therapy, immunomodulating therapy, radiotherapy, and/or monoclonal antibody) used for treatment of CLL or SLL.

2\. Patients carrying del(17p) and/or TP53 mutation as assessed by central laboratory.

3\. History of other malignancies, except:

1. Malignancy treated with curative intent and with no known active disease present for ≥3 before the first dose of study drug and felt to be at low risk for recurrence by the treating physician
2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
3. Adequately treated carcinoma in situ without evidence of disease. 4. Known or suspected history of Richter's transformation. 5. Known hypersensitivity to one or more study drugs. 6. Known bleeding disorders (eg, von Willebrand's disease or hemophilia). 7. History of stroke or intracranial hemorrhage within 6 months prior to enrollment.

   8\. Known history of human immunodeficiency virus (HIV) or active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV). Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrolment. Those who are PCR positive will be excluded. 9. Unable to swallow capsules/tablets or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction.

   10\. Concomitant use of warfarin or other vitamin K antagonists. 11. Major surgery within 4 weeks of first dose of study drug.

Where it's running

• Strategic Research Program on CLL
  Milan, Mi, Italy Recruiting

Study contacts

• Study coordinator: Paolo Ghia, MD, PhD
• Email: ghia.paolo@hsr.it
• Phone: +39022643

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• LP-168 plus obinutuzumab for previously treated and BTK T474I‑mutated CLL/SLL

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• Time-limited combination of pirtobrutinib, venetoclax and obinutuzumab for relapsed CLL/SLL

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• Comparing sonrotoclax combinations versus venetoclax plus rituximab for relapsed or refractory CLL/SLL

  This trial will test whether sonrotoclax combined with obinutuzumab or with rituximab works better than venetoclax plus rituximab for adults whose CLL/SLL has come back or not responded to prior treatment.

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• Zanubrutinib, obinutuzumab, and sonrotoclax for newly diagnosed CLL or SLL

  This trial tests whether the three‑drug combination of zanubrutinib, obinutuzumab, and sonrotoclax can produce undetectable measurable residual disease (uMRD) in people with previously untreated CLL or SLL.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.