Combination treatment for high-risk chronic lymphocytic leukemia

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 multicenter, open-label, randomized phase 3 trial aims to compare the effectiveness of a triple combination therapy using acalabrutinib, obinutuzumab, and venetoclax against a dual therapy of obinutuzumab and venetoclax in patients with high-risk chronic lymphocytic leukemia (CLL). The study focuses on patients with specific genetic markers indicating high risk, such as 17p-deletion, TP53-mutation, or complex karyotype. By evaluating progression-free survival, the trial seeks to address a significant medical need for more effective treatment options in this aggressive form of leukemia.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Documented CLL/SLL requiring treatment according to iwCLL criteria
* Age at least 18 years
* At least one of the following risk factors: 17p-deletion, TP53-mutation, complex karyotype (defined as defined as the presence of 3 or more chromosomal aberrations in 2 or more metaphases) or an unmutated IGHV gene status.
* Life expectancy ≥ six months
* Adequate bone marrow function indicated by a platelet count \>30 x10\^9/l
* Creatinine clearance ≥ 30ml/min
* Adequate liver function as indicated by a total bilirubin ≤ 2 x, AST/ ALT ≤ 2.5 x the institutional ULN value, unless directly attributable to the patient's CLL or to Gilbert's Syndrome
* Negative testing for hepatitis B (HbsAg negative and anti-HBc negative; patients positive for anti-HBc may be included if PCR for HBV DNA is negative and HBV-DNA PCR is performed every month until 12 months after last treatment cycle),or hepatitis C (negative testing for hepatitis C RNA within 6 wee
* ks prior to registration for study screening (i.e. PCR only required when serology was positive))
* ECOG (Eastern Cooperative Oncology Group Performance Status) status 0-2

Exclusion Criteria:

* Any prior CLL-specific therapies (except corticosteroid treatment administered due to necessary immediate intervention; within the last 10 days before start of study treatment, only dose equivalents up to 20 mg prednisolone are permitted)
* Absence of high risk disease (17p-deletion, TP53-mutation complex karyotype
* An individual organ/system impairment score of 4 as assessed by the CIRS definition (e.g. advanced cardiac disease (NYHA class 3 or 4) limiting the ability to receive the study treatment or any other life-threatening illness, medical condition or organ system dysfunction that, in the investigator´s opinion, could compromise the patients safety or interfere with the absorption or metabolism of the study drugs (e.g. inability to swallow tablets or impaired resorption in the gastrointestinal tract)
* Transformation of CLL (Richter transformation)
* Malignancies other than CLL currently requiring systemic therapies
* Uncontrolled or active infection of HIV/PML or any other active infection
* Anticoagulant therapy with warfarin or phenoprocoumon
* Pregnant women and nursing mothers

Where it's running

• Helios Klinikum Bad Saarow
  Bad Saarow, Germany Recruiting
• DRK Kliniken Berlin Köpenick
  Berlin, Germany Recruiting
• Ev. Diakoniekrankenhaus
  Bremen, Germany Recruiting
• Universitätsklinik Köln
  Cologne, Germany Recruiting
• St. Johannes Hospital
  Dortmund, Germany Recruiting
• Marien Hospital Düsseldorf
  Düsseldorf, Germany Recruiting

Study contacts

• Principal investigator: Barbara Eichhorst, MD, Prof. — Department I of Internal Medicine, University Hospital Cologne
• Study coordinator: Barbara Eichhorst, MD, Prof.
• Email: barbara.eichhorst@uk-koeln.de
• Phone: +4922147888220

Similar studies

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

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

  This study is testing if the combination of venetoclax with either obinutuzumab or acalabrutinib is safe for adults with untreated chronic lymphocytic leukemia.

  Recruiting at 69 sites Phase 3 AbbVie · Tucson, Arizona and 69 other locations · NCT06428019

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

  This study is testing a new combination of three medications to see if it can help people with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma feel better and live longer.

  Recruiting Phase 1 OHSU Knight Cancer Institute · Portland, Oregon · NCT05943496

• 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.

  Recruiting Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT05336812

• 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.