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B-cell lymphoma-2 (BCL-2) inhibitor

Venetoclax for Chronic Lymphocytic Leukemia

Phase 3
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study drug until the last participant completed week 65 assessments (data cut-off date of 13 october 2021); overall median time on follow-up was up to 787 days
Awards & highlights

Study Summary

This trial is studying different ways to give induction therapy to people with previously untreated Chronic Lymphocytic Leukemia.

Eligible Conditions
  • Chronic Lymphocytic Leukemia
  • Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study drug until the last participant completed week 65 assessments (data cut-off date of 13 october 2021); overall median time on follow-up was up to 787 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug until the last participant completed week 65 assessments (data cut-off date of 13 october 2021); overall median time on follow-up was up to 787 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Response Rate
Percentage of Participants Achieving Low Tumor Burden Status With Induction of Obinutuzumab or Obinutuzumab Plus Bendamustine (Debulking Period)
Secondary outcome measures
Duration of Response (DoR)
Overall Response Rate (ORR)
Overall Survival (OS)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Obinutuzumab/bendamustineExperimental Treatment3 Interventions
Obinutuzumab (100 mg on Day 1 of Cycle 1, 900 mg on Day 2 of Cycle 1, and 1000 mg on Days 8 and 15 of Cycle 1 and Day 1 of Cycle 2; for Cycles 3 - 6 (1000 mg on Day 1) only as needed for participants to achieve low tumor burden) was administered via intravenous infusion during the debulking regimen. Bendamustine (90 mg/m^2 ) was to be administered to those with nodes or nodal mass > 10 cm, or with del(11q) and > 5 cm nodes, or at the discretion of the investigator as above, via intravenous infusion over 10 minutes on Days 1 and 2 (or Days 2 and 3 at the discretion of the investigator during Cycle 1) of each 28-day cycle for up to 6 cycles during the debulking regimen. After debulking, obinutuzumab (1000 mg) was administered via intravenous infusion on Day 1 of one 5-week and four 4-week cycles during the obinutuzumab/venetoclax combination part of the regimen. Venetoclax was administered according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg.
Group II: ObinutuzumabExperimental Treatment2 Interventions
Obinutuzumab (100 mg on Day 1 of Cycle 1, 900 mg on Day 2 of Cycle 1, and 1000 mg on Days 8 and 15 of Cycle 1 and Day 1 of Cycle 2; for Cycles 3 - 6 (1000 mg on Day 1) only as needed for participants to achieve low tumor burden) was administered via intravenous infusion during the debulking regimen. After debulking, obinutuzumab (1000 mg) was administered via intravenous infusion on Day 1 of one 5-week and four 4-week cycles during the obinutuzumab/venetoclax combination part of the regimen. Venetoclax was administered according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Bendamustine
2015
Completed Phase 3
~2950
Obinutuzumab
2015
Completed Phase 3
~3250

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
952 Previous Clinical Trials
500,364 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
392 Previous Clinical Trials
145,198 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some other notable examples of research done on Venetoclax?

"At this moment, there are 355 ongoing Venetoclax trials with 53 in Phase 3. The majority of these trials are taking place in Edmonton, Alberta; however, there are 13044 total locations running these trials."

Answered by AI

Could you please list how many medical facilities are participating in this research project?

"To limit inconvenience for participants, the study is being run at 18 sites which are situated near major cities including Tyler, Eugene and McAllen."

Answered by AI

For what reasons is Venetoclax commonly prescribed?

"Venetoclax can be used as a treatment for refractory mantle cell lymphoma, refractory follicular lymphoma, and chronic lymphocytic leukemia (cll)."

Answered by AI

Could adolescents benefit from this proposed treatment?

"Those aged 18-99 are able to enroll in this trial, as long as they meet the other eligibility requirements."

Answered by AI

Who does this clinical trial hope to include as participants?

"The eligibility criteria for this trial includes being between the ages of 18-99 and having small lymphocytic lymphoma. The trial is looking to recruit 120 patients in total."

Answered by AI

Are there any positions available for applicants in this trial?

"This particular clinical trial is not currently looking for patients, as stated on clinicaltrials.gov. This study was first posted on 2018-08-10 and was updated for the last time on 2022-10-07. Although this trial is not searching for patients anymore, there are 1924 other clinical trials presently accepting participants at this time."

Answered by AI

What are the odds of a patient developing harmful side-effects from Venetoclax?

"There is some efficacy data and multiple rounds of safety data from Phase 3 trials, so our team at Power gave Venetoclax a safety score of 3."

Answered by AI

How many guinea pigs are part of this test group?

"Unfortunately, this particular study is no longer active. It was created on 2018-08-10 and last updated on 2022-10-07. However, there are 1569 other trials for small lymphocytic lymphoma and 355 trials involving Venetoclax that are searching for participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy
2018. "A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03406156.
~18 spots leftby Apr 2025
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