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New treatment option for Chronic Lymphocytic Leukemia
Official title Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
ClinicalTrials.gov ID: NCT04269902
What this study is testing
What is Obinutuzumab?
Obinutuzumab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for chronic lymphocytic leukemia.
Also referred to as Anti-CD20 Monoclonal Antibody R7159, GA 101.
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
- This phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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
- Participants must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as...
- Participants must have CLL-International Prognostic Index (CLL-IPI) score \>= 4 and/or complex cytogenetics (defined as 3+ chromosomal abnormalities)
- Cytogenetic AND/OR FISH analyses must be completed at a Clinical Laboratory Improvement Act (CLIA)-approved (or laboratories accredited under...
- TP53 gene mutation analysis performed at any CLIA-approved (or laboratories accredited under Accreditation Canada Diagnostics) lab (if completed)...
- Note: TP53 gene mutation analysis is recommended but not required if the participant meets disease-related study criteria via a combination of risk...
See the full eligibility criteria
Who can join
- Participants must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as CLL throughout) according to the 2018 International Workshop on CLL...
- Participants must have CLL-International Prognostic Index (CLL-IPI) score \>= 4 and/or complex cytogenetics (defined as 3+ chromosomal abnormalities)
- Cytogenetic AND/OR FISH analyses must be completed at a Clinical Laboratory Improvement Act (CLIA)-approved (or laboratories accredited under Accreditation Canada Diagnostics to conduct FISH analyses) laboratory within...
- TP53 gene mutation analysis performed at any CLIA-approved (or laboratories accredited under Accreditation Canada Diagnostics) lab (if completed) must be obtained within 18 months prior to registration. This sequencing...
- Note: TP53 gene mutation analysis is recommended but not required if the participant meets disease-related study criteria via a combination of risk factors that totals a score of 4 on the CLL-IPI score and/or has...
- Immunoglobulin heavy chain locus variable (IgVH) gene mutation analysis performed at any CLIA-approved lab (or laboratories accredited under Accreditation Canada Diagnostics) must be obtained prior to registration (at...
- Serum beta-2 microglobulin level must be obtained within 28 days prior to registration
- Participants must not meet any of the IWCLL specified criteria for active CLL therapy
- Treatment with high dose corticosteroids and/or intravenous immunoglobulin for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment
- Steroids used for treatment of conditions other than CLL/SLL must be at a dose of at most 20 mg/day of prednisone or equivalent corticosteroid at the time of registration
- Prior therapy with anti CD20 monoclonal antibodies is not allowed
- Participants must not have received or be currently receiving any prior CLL-directed therapy, including non-protocol-related therapy, anti-cancer immunotherapy, experimental therapy (with exception of agents approved...
- Participants must not be receiving or planning to receive any other investigational agents before completing protocol therapy
- Participants must be \>= 18 years of age
- Participants must have Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
- Platelet count \>= 100,000/mm\^3 within 28 days prior to registration
- Absolute neutrophil count (ANC) \>= 1,000/mm\^3 within 28 days prior to registration
- Creatinine clearance \>= 30mL/min (by Cockcroft Gault) within 28 days prior to registration
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3.0 x upper limit of normal (ULN) within 28 days prior to registration
- Total bilirubin =\< 2.0 x ULN (or 5.0 x ULN if the participant has a history of Gilbert's disease), within 28 days prior to registration
- Participants must be able to take oral medications
- Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- Participants with history of malignancy are allowed providing the cancer has not required active treatment within 2 years prior to registration (hormonal therapy is permissible). The following exceptions are...
- Participants must not have current, clinically significant gastrointestinal malabsorption, in the opinion of treating doctor
- Participants must not have cirrhosis
- Obinutuzumab has been associated with hepatitis reactivation. Participants must not have uncontrolled active infection with hepatitis B or C. Participants with latent hepatitis B infection must agree to take prophylaxis...
- Active infection with hepatitis B or C:
- Active infection is defined as detectable hepatitis B deoxyribonucleic acid (DNA) or hepatitis C ribonucleic acid (RNA) by quantitative polymerase chain reaction (PCR).
- Latent infection with hepatitis B:
- Latent infection is defined as meeting all of the following criteria:
- Hepatitis B surface antigen positive
- Anti-hepatitis B total core antibody positive
- Anti-hepatitis IgM core antibody undetectable
- Hepatitis B PCR undetectable
- Participants with latent hepatitis B infection must agree to take prophylaxis with anti-hepatitis agents during and for 6 months following active protocol therapy with V-O.
- Participants who have received intravenous immunoglobulin (IVIG) therapy within 6 months who are hepatitis B core total antibody positive but PCR undetectable are not mandated to take prophylaxis
- Participants must not have had major surgery within 30 days prior registration or minor surgery within 7 days prior to registration. Examples of major surgery include neurosurgical procedures, joint replacements, and...
- Participants must not have known bleeding disorders (e.g., von Willebrand's disease or hemophilia)
- Participants must not have a history of stroke or intracranial hemorrhage within 6 months prior to enrollment
- Participants must not require continued therapy with a strong inhibitor or inducer of CYP3A4/5, as venetoclax is extensively metabolized by CYP3A4/5
- Participants must not have uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura
- Participants must not have any currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association...
- Participants must not have a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment
- Participants must not be pregnant or nursing, as there are no safety data available for these drug regimens during pregnancy. Women/men of reproductive potential must have agreed to use an effective contraceptive...
- Participants must agree to have specimens submitted for translational medicine (MRD) as outlined
- Participants must be offered the opportunity to participate in specimen banking for future research as outlined.
- NOTE: With participant's consent, the site must follow through with specimen submission as outlined
- Participants who are able to complete patient reported outcome (PRO) forms in English, Spanish, French, German, Russian or Mandarin must be offered the opportunity to participate in the quality of life assessments...
- Participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Anchorage, Alaska, United States
- Fairbanks, Alaska, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Fort Smith, Arkansas, United States
- Hot Springs, Arkansas, United States
- Jonesboro, Arkansas, United States
- Anaheim, California, United States
- Arroyo Grande, California, United States
- Baldwin Park, California, United States
- Bellflower, California, United States
- Burbank, California, United States
- Cameron Park, California, United States
- Carmichael, California, United States
- Chico, California, United States
- Costa Mesa, California, United States
- Duarte, California, United States
- Elk Grove, California, United States
- Fontana, California, United States
+ 434 more site(s).
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 Birmingham, Alabama, United States; Anchorage, Alaska, United States; Fairbanks, Alaska, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Fort Smith, Arkansas, United States and 448 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.