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Alkylating agents
Rituximab + Bendamustine/Ibrutinib for Chronic Lymphocytic Leukemia
Phase 3
Waitlist Available
Led By Jennifer A Woyach
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up performed at 2.5 years after the last patient enrolled
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing rituximab with bendamustine hydrochloride or ibrutinib compared to ibrutinib alone to see how well they work in treating patients with previously untreated chronic lymphocytic leukemia.
Who is the study for?
This trial is for older patients (65+) with untreated chronic lymphocytic leukemia who meet specific diagnostic criteria, have a certain level of physical fitness (ECOG 0-2), and organ function. They must not have had prior CLL treatment except for steroids or rituximab for autoimmune complications, no major surgery within 10 days before enrollment, and no active hepatitis B or uncontrolled infections.
What is being tested?
The study compares the effectiveness of rituximab combined with bendamustine hydrochloride or ibrutinib versus using just ibrutinib alone in treating CLL. It aims to determine which therapy works best at stopping cancer cell growth by either killing cells, preventing division, or blocking enzymes needed for cell growth.
What are the potential side effects?
Potential side effects include reactions related to infusion such as fever and chills; low blood counts leading to increased infection risk; liver issues reflected in abnormal blood tests; fatigue; allergic reactions; and possibly others depending on individual patient health conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from study entry to the time of documented disease progression or death. the analysis was event driven, performed at 2.5 years after the last patient enrolled;up to 4 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from study entry to the time of documented disease progression or death. the analysis was event driven, performed at 2.5 years after the last patient enrolled;up to 4 years.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression Free Survival (PFS)
Secondary study objectives
Duration of Response (DOR) (Complete Response [CR], CCR, Nodular Partial Response [nPR], Partial Response [PR], and PRL)
Overall Survival (OS) at 2 Years
Percentage of Patients Achieving Any Response to Treatment (Overall Response Rate [ORR] [Complete Response [CR], CCR, Nodular Partial Response [nPR], Partial Response [PR], and PRL])
+5 moreOther study objectives
Geriatric Functional Status (Optional)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm III (ibrutinib, rituximab)Experimental Treatment4 Interventions
Patients receive ibrutinib as in Arm II. Patients receive rituximab IV on days 1, 8, 15, and 22 of course 2 and on day 1 of courses 3-6. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (ibrutinib)Experimental Treatment3 Interventions
Patients receive ibrutinib PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group III: Arm I (rituximab, bendamustine hydrochloride)Active Control4 Interventions
Patients receive rituximab IV on day 1 (day 0 course 1) and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm II.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 4
~2060
Rituximab
1999
Completed Phase 4
~2990
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,920 Previous Clinical Trials
41,016,387 Total Patients Enrolled
Jennifer A WoyachPrincipal InvestigatorAlliance for Clinical Trials in Oncology
1 Previous Clinical Trials
454 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My CLL cells show specific markers and lack a certain genetic change.My CLL is at an intermediate or high-risk stage.My condition is at an intermediate stage with enlarged lymph nodes and possibly an enlarged liver or spleen.I meet the treatment criteria for my condition as per the IWCLL 2008 guidelines.My lymph nodes are very large or getting worse.I am 65 years old or older.I have high-risk leukemia with low blood counts not caused by an autoimmune condition.I have worsening anemia or low platelet counts not caused by an autoimmune condition.My spleen is very large, growing, or causing symptoms.I have an autoimmune blood condition that doesn't improve with standard treatments.I experience significant symptoms due to my condition.I have lost more than 10% of my weight without trying in the last 6 months.I often feel very tired.I have had a fever over 100.5°F for more than 2 weeks without signs of infection.I receive IVIG and may have false positive hepatitis B tests but no active infection.I am able to get out of my bed or chair and move around.I have had night sweats for over a month without being sick.I do not have active hepatitis B or, if I have been exposed, my hepatitis B DNA is negative.I do not have severe heart failure, unstable chest pain, or uncontrolled irregular heartbeat.I haven't had major surgery in the last 10 days or minor surgery in the last 7 days.I have not had a heart attack, brain bleed, or stroke in the last 6 months.My white blood cell count is healthy, not due to cancer in my bone marrow.I have HIV with a CD4 count of 350 or higher and am not on certain medications.I take 20 mg or less of prednisone or its equivalent daily.I am not currently on blood thinners like heparin or warfarin.You should not have a known allergy to mannitol.I have been diagnosed with CLL based on specific international criteria.You have not had a strong allergic reaction to rituximab, except for reactions during the infusion process.I have not received treatment for CLL, except possibly steroids or rituximab for specific complications.I finished treatment with rituximab or high dose steroids for CLL issues over 4 weeks ago.I have never had Richter's transformation or prolymphocytic leukemia.I am not on strong medication that affects liver enzyme levels.I do not have an ongoing infection that needs IV antibiotics.My kidneys work well enough (creatinine clearance >= 40 mL/min).
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (rituximab, bendamustine hydrochloride)
- Group 2: Arm II (ibrutinib)
- Group 3: Arm III (ibrutinib, rituximab)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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