Evaluating the risk of tumor lysis syndrome in adults with chronic lymphocytic leukemia receiving venetoclax with obinutuzumab or acalabrutinib

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 study investigates the safety of venetoclax when combined with either obinutuzumab or acalabrutinib in adults with previously untreated chronic lymphocytic leukemia (CLL). Participants will be assigned to one of four treatment arms, receiving either oral venetoclax with IV obinutuzumab or oral acalabrutinib, with a specific dosing schedule. The study aims to assess adverse events and changes in disease activity among approximately 120 participants across 80 sites worldwide.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of documented, previously untreated, chronic lymphocytic leukemia (CLL) requiring treatment according to the 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria and have a life expectancy of \> 6 months.
* Previously untreated small lymphocytic lymphoma (SLL) meeting the 2018 iwCLL criteria for treatment will also be equally considered as CLL for eligibility, screening, treatment and evaluation.
* Eastern Cooperative Oncology Group (ECOG) performance status \<= 2.
* Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening, unless cytopenia is due to marrow involvement of CLL as listed in the protocol.
* Creatinine clearance (CrCl) \>= 30 mL/min using the Cockcroft-Gault formula are eligible for inclusion.

Exclusion Criteria:

\- Active/uncontrolled infection, no Richter's transformation, no active immune thrombocytopenia.

Where it's running

• Arizona Oncology - Tucson - Rudasill /ID# 267552
  Tucson, Arizona, United States Recruiting
• Southern VA Health Care System /ID# 266254
  Tucson, Arizona, United States Recruiting
• UCSF FRESNO/Community Cancer Institute /ID# 270874
  Clovis, California, United States Recruiting
• Valkyrie Clinical Trials /ID# 268151
  Los Angeles, California, United States Recruiting
• Rocky Mountain Cancer Centers - Aurora /ID# 267549
  Aurora, Colorado, United States Recruiting
• Yale University School of Medicine /ID# 266224
  New Haven, Connecticut, United States Recruiting

+20 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

Similar studies

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

• Combination treatment for untreated chronic lymphocytic leukemia and small lymphocytic lymphoma

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• Acalabrutinib combined with venetoclax or obinutuzumab for treating chronic lymphocytic leukemia

  This study is testing if a new combination of two drugs, acalabrutinib with either venetoclax or obinutuzumab, can help people with chronic lymphocytic leukemia who haven't been treated before by reducing cancer cells in their bone marrow.

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• Combination treatment for high-risk chronic lymphocytic leukemia

  This study is testing if a new combination of three drugs can help people with high-risk chronic lymphocytic leukemia live longer without their cancer getting worse compared to a combination of two drugs.

  Recruiting at 30 sites Phase 3 German CLL Study Group · Bad Saarow and 29 other locations · NCT05197192

• Acalabrutinib with or without Obinutuzumab for early-stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

  This study is testing whether a new drug called acalabrutinib, alone or with another drug called obinutuzumab, can help people with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma feel better and live longer.

  Recruiting at 2 sites Phase 2 Mayo Clinic · Scottsdale, Arizona and 2 other locations · NCT03516617

• Tafasitamab plus Acalabrutinib and Venetoclax for newly treated CLL/SLL

  This phase II study tests a combination of tafasitamab, acalabrutinib, and venetoclax in adults who are newly diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma to see if it is safe and effective.

  Recruiting at 2 sites Phase 2 City of Hope Medical Center · Duarte, California and 1 other locations · NCT07582159

• Acalabrutinib for CLL in routine care in Belarus

  This project will see how well acalabrutinib works and how safe it is for adults with chronic lymphocytic leukemia treated in routine clinical practice in Belarus.

  Recruiting at 3 sites AstraZeneca · Grodno and 3 other locations · NCT07288515

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.