Lymphocytic Leukemia, ChronicPhase 1NCT01685892
A Study of Venetoclax in Combination With Obinutuzumab in Participants With Chronic Lymphocytic Leukemia
A Phase 1 study testing Obinutuzumab and Venetoclax in people with Lymphocytic Leukemia, Chronic, run by Genentech, Inc. at 10 sites in 2 countries.
Trial summary
This multi-center, open-label, dose-finding study will evaluate the safety and pharmacokinetics as well as the preliminary efficacy of venetoclax (GDC-0199; ABT-199) administered in combination with obinutuzumab to participants with relapsed/refractory or previously untreated chronic lymphocytic leukemia (CLL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphocytic Leukemia, Chronic
- What is being tested?
- Obinutuzumab and Venetoclax
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 29 Nov 2012to 23 Aug 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of relapsing/refractory or previously untreated chronic lymphocytic leukemia
- Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to (</=) 1
- Adequate bone marrow function
- Adequate coagulation, renal and hepatic function
- For all participants, agreement to remain abstinent or use contraceptive methods that result in a failure rate of less than (<) 1% per year during the treatment period and for at least 90 days (30 days for women) after the last dose of venetoclax or 18 months after the last dose of obinutuzumab, whichever is longer
Who cannot join
- Participants who have undergone allogenic stem cell transplant are ineligible unless they meet the following criteria, a) participants who are off all immunosuppressive therapy, b) participants who have no signs and/or symptoms of acute or chronic graft versus host disease, or c) participants must have appropriate hematology counts
- Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
- Investigational or anti-cancer therapy within 5 half-lives prior to the first dose of study drug
- History of significant renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States7 sites
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center
Denver, Colorado, 80218
The Methodist Hospital Research Institute; Academic Office of Clinical Trials
Houston, Texas, 77030
UCSD Moores Cancer Center
La Jolla, California, 92093
SCRI-Tennessee Oncology
Nashville, Tennessee, 37203
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, 10021
Oncology Associates of Oregon
Springfield, Oregon, 97477
United Kingdom3 sites
St James University Hospital
Leeds, LS9 7TF
Leicester Royal Infirmary NHS Trust
Leicester, LE1 5WW
Barts and The London School of Medicine and Dentistry; Queen Mary, University of London
London, E1 2AD
About this study
Official title: A Phase Ib Multicenter Dose-Finding and Safety Study of Venetoclax and Obinutuzumab in Patients With Relapsed or Refractory or Previously Untreated Chronic Lymphocytic Leukemia
This multi-center, open-label, dose-finding study will evaluate the safety and pharmacokinetics as well as the preliminary efficacy of venetoclax (GDC-0199; ABT-199) administered in combination with obinutuzumab to participants with relapsed/refractory or previously untreated chronic lymphocytic leukemia (CLL). The study is comprised of two stages for each participant population: a dose-finding stage and a safety-expansion stage. The dose-finding stage will explore multiple doses of venetoclax to be used in combination with a fixed dose of obinutuzumab. The dose-finding stage will also explore two schedules for drug administration, Schedule A (venetoclax introduced before obinutuzumab) and Schedule B (venetoclax introduced after obinutuzumab).
- Conditions
- Lymphocytic Leukemia, Chronic
- Being tested
- Obinutuzumab, Venetoclax
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObinutuzumabDrug
Also called GA101; RO5072759
Participants will receive IV infusion of obinutuzumab 100 milligrams (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 on Day 1 of Cycles 2-6.
VenetoclaxDrug
Also called ABT-199, GDC-0199
Participants will receive multiple doses of venetoclax orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Dose-Finding: Schedule A: Relapsed/Refractory CLL | Experimental | All 4 cohorts will begin venetoclax administration after the ramp-up period of 5 weeks. In 4 cohorts of participants with relapsed/refractory CLL escalating doses of venetoclax will be administered in combination with fixed dose obinutuzumab in the dose-finding stage. In Schedule A, venetoclax will be introduced before obinutuzumab. Schedule A will be explored prior to Schedule B. Receives: Drug: Obinutuzumab; Drug: Venetoclax |
| Dose-Finding: Schedule B: Relapsed/Refractory CLL | Experimental | In 4 cohorts of participants with relapsed/refractory CLL escalating doses of venetoclax will be administered in combination with fixed dose obinutuzumab in the dose-finding stage. In Schedule B, venetoclax will be introduced after obinutuzumab. Schedule A will be explored prior to Schedule B. Receives: Drug: Obinutuzumab; Drug: Venetoclax |
| Dose-Finding: Schedule A: Previously Untreated CLL | Experimental | All 4 cohorts will begin venetoclax administration after the ramp-up period of 5 weeks. In 4 cohorts of participants with previously untreated CLL escalating doses of venetoclax will be administered in combination with fixed dose obinutuzumab in the dose-finding stage. In Schedule A, venetoclax will be introduced before obinutuzumab. Schedule A will be explored prior to Schedule B. Receives: Drug: Obinutuzumab; Drug: Venetoclax |
| Dose-Finding: Schedule B: Previously Untreated CLL | Experimental | In 4 cohorts of participants with previously untreated CLL escalating doses of venetoclax will be administered in combination with fixed dose obinutuzumab in the dose-finding stage. In Schedule B, venetoclax will be introduced after obinutuzumab. Schedule A will be explored prior to Schedule B. Receives: Drug: Obinutuzumab; Drug: Venetoclax |
| Safety Expansion: Relapsed/Refractory CLL | Experimental | In participants with relapsed/refractory CLL a recommended dose of venetoclax will be administered in combination with obinutuzumab in the safety expansion stage. Schedule A or B will be used for the expansion cohort after a review of available safety data from the dose finding stage. Receives: Drug: Obinutuzumab; Drug: Venetoclax |
| Safety Expansion: Previously Untreated CLL | Experimental | In participants with previously untreated CLL a recommended dose of venetoclax will be administered in combination with obinutuzumab in the safety expansion stage. Schedule A or B will be used for the expansion cohort after a review of available safety data from the dose finding stage. Receives: Drug: Obinutuzumab; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Dose Limiting Toxicities (DLTs)
Measured: Schedule (Sch) A (Cycle 1 Day 1 to Day 21), Sch B (Cycle 1 Day 22 to Cycle 2 Day 28) (1 Cycle=28 days)
Maximum Tolerated Dose (MTD) of Venetoclax in Combination with Obinutuzumab
Measured: Sch A (Cycle 1 Day 1 to Day 21), Sch B (Cycle 1 Day 22 to Cycle 2 Day 28) (1 Cycle=28 days)
Secondary outcomes (17)
Percentage of Participants with Adverse Events
Measured: Baseline up to end of study (up to approximately 5 years and 5 months)
Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) to Obinutuzumab
Measured: Baseline up to Cycle 6 (1 Cycle=28 days)
Area Under the Concentration-Time Curve (AUC) of Venetoclax
Measured: Baseline up to Cycle 6 (1 Cycle=28 days)
Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax
Measured: Baseline up to Cycle 6 (1 Cycle=28 days)
Maximal Plasma Concentration (Cmax) of Venetoclax
Measured: Baseline up to Cycle 6 (1 Cycle=28 days)
Minimum Plasma Concentration (Cmin) of Venetoclax
Measured: Baseline up to Cycle 6 (1 Cycle=28 days)
Cmax of Obinutuzumab
Measured: Baseline up to Cycle 6 (1 Cycle=28 days)
Cmin of Obinutuzumab
Measured: Baseline up to Cycle 6 (1 Cycle=28 days)
Percentage of Participants with Confirmed Complete Response (CR) as Determined by Standard CLL Response Criteria
Measured: Baseline up to end of study (up to approximately 5 years and 5 months)
Percentage of Participants with Objective Response (Partial Response [PR] or CR [Including Cytopenic CR] as Determined by Standard CLL Response Criteria
Measured: Baseline up to end of study (up to approximately 5 years and 5 months)
Duration of Objective Response as Determined by Standard CLL Response Criteria
Measured: Baseline up to end of study (up to approximately 5 years and 5 months)
Overall Survival
Measured: Baseline up to death or end of study (up to approximately 5 years and 5 months)
Progression-Free Survival as Determined by Standard CLL Response Criteria
Measured: Baseline up to end of study (up to approximately 5 years and 5 months)
Change from Baseline in Number of B-Cells
Measured: Baseline up to end of study (up to approximately 5 years and 5 months)
Change from Baseline in Number of T-Cells
Measured: Baseline up to end of study (up to approximately 5 years and 5 months)
Change from Baseline in Number of Natural Killer (NK) Cells
Measured: Baseline up to end of study (up to approximately 5 years and 5 months)
Change from Baseline in Serum Immunoglobulin Level
Measured: Baseline up to end of study (up to approximately 5 years and 5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study start29 Nov 2012
- Primary completion21 May 2018
- Study completion23 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lymphocytic Leukemia, ChronicStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AbbVie (prior sponsor, Abbott)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685892
- Sponsor's protocol ID
- GP28331
- Other IDs
- 2012-002038-34
- Status last verified
- Jan 2020
- First submitted
- 12 Sep 2012
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Samineni D, Gibiansky L, Wang B, Vadhavkar S, Rajwanshi R, Tandon M, Sinha A, Al-Sawaf O, Fischer K, Hallek M, Salem AH, Li C, Miles D. Pharmacokinetics and Exposure-Response Analysis of Venetoclax + Obinutuzumab in Chronic Lymphocytic Leukemia: Phase 1b Study and Phase 3 CLL14 Trial. Adv Ther. 2022 Aug;39(8):3635-3653. doi: 10.1007/s12325-022-02170-w. Epub 2022 Jun 16.
PubMed 35708885Flinn IW, Gribben JG, Dyer MJS, Wierda W, Maris MB, Furman RR, Hillmen P, Rogers KA, Iyer SP, Quillet-Mary A, Ysebaert L, Walter HS, Verdugo M, Klein C, Huang H, Jiang Y, Lozanski G, Pignataro DS, Humphrey K, Mobasher M, Kipps TJ. Phase 1b study of venetoclax-obinutuzumab in previously untreated and relapsed/refractory chronic lymphocytic leukemia. Blood. 2019 Jun 27;133(26):2765-2775. doi: 10.1182/blood-2019-01-896290. Epub 2019 Mar 12.
PubMed 30862645
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Multicenter Dose-Finding and Safety Study of Venetoclax and Obinutuzumab in Patients With Relapsed or Refractory or Previously Untreated Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT01685892
- Acronym / sponsor ID
- GP28331
- Conditions
- Lymphocytic Leukemia, Chronic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Collaborators
- AbbVie (prior sponsor, Abbott)
- Study start
- 29 Nov 2012 (actual)
- Primary completion
- 21 May 2018 (actual)
- Study completion
- 23 Aug 2019 (actual)
- First posted
- 14 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multi-center, open-label, dose-finding study will evaluate the safety and pharmacokinetics as well as the preliminary efficacy of venetoclax (GDC-0199; ABT-199) administered in combination with obinutuzumab to participants with relapsed/refractory or previously untreated chronic lymphocytic leukemia (CLL). The study is comprised of two stages for each participant population: a dose-finding stage and a safety-expansion stage. The dose-finding stage will explore multiple doses of venetoclax to be used in combination with a fixed dose of obinutuzumab. The dose-finding stage will also explore two schedules for drug administration, Schedule A (venetoclax introduced before obinutuzumab) and Schedule B (venetoclax introduced after obinutuzumab).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dose-Finding: Schedule A: Relapsed/Refractory CLL | Experimental | Drug: Obinutuzumab, Drug: VenetoclaxAll 4 cohorts will begin venetoclax administration after the ramp-up period of 5 weeks. In 4 cohorts of participants with relapsed/refractory CLL escalating doses of venetoclax will be administered in combination with fixed dose obinutuzumab in the dose-finding stage. In Schedule A, venetoclax will be introduced before obinutuzumab. Schedule A will be explored prior to Schedule B. |
| Dose-Finding: Schedule B: Relapsed/Refractory CLL | Experimental | Drug: Obinutuzumab, Drug: VenetoclaxIn 4 cohorts of participants with relapsed/refractory CLL escalating doses of venetoclax will be administered in combination with fixed dose obinutuzumab in the dose-finding stage. In Schedule B, venetoclax will be introduced after obinutuzumab. Schedule A will be explored prior to Schedule B. |
| Dose-Finding: Schedule A: Previously Untreated CLL | Experimental | Drug: Obinutuzumab, Drug: VenetoclaxAll 4 cohorts will begin venetoclax administration after the ramp-up period of 5 weeks. In 4 cohorts of participants with previously untreated CLL escalating doses of venetoclax will be administered in combination with fixed dose obinutuzumab in the dose-finding stage. In Schedule A, venetoclax will be introduced before obinutuzumab. Schedule A will be explored prior to Schedule B. |
| Dose-Finding: Schedule B: Previously Untreated CLL | Experimental | Drug: Obinutuzumab, Drug: VenetoclaxIn 4 cohorts of participants with previously untreated CLL escalating doses of venetoclax will be administered in combination with fixed dose obinutuzumab in the dose-finding stage. In Schedule B, venetoclax will be introduced after obinutuzumab. Schedule A will be explored prior to Schedule B. |
| Safety Expansion: Relapsed/Refractory CLL | Experimental | Drug: Obinutuzumab, Drug: VenetoclaxIn participants with relapsed/refractory CLL a recommended dose of venetoclax will be administered in combination with obinutuzumab in the safety expansion stage. Schedule A or B will be used for the expansion cohort after a review of available safety data from the dose finding stage. |
| Safety Expansion: Previously Untreated CLL | Experimental | Drug: Obinutuzumab, Drug: VenetoclaxIn participants with previously untreated CLL a recommended dose of venetoclax will be administered in combination with obinutuzumab in the safety expansion stage. Schedule A or B will be used for the expansion cohort after a review of available safety data from the dose finding stage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of relapsing/refractory or previously untreated chronic lymphocytic leukemia
- Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to (</=) 1
- Adequate bone marrow function
- Adequate coagulation, renal and hepatic function
- For all participants, agreement to remain abstinent or use contraceptive methods that result in a failure rate of less than (<) 1% per year during the treatment period and for at least 90 days (30 days for women) after the last dose of venetoclax or 18 months after the last dose of obinutuzumab, whichever is longer
Key exclusion criteria (5 listed)
- Participants who have undergone allogenic stem cell transplant are ineligible unless they meet the following criteria, a) participants who are off all immunosuppressive therapy, b) participants who have no signs and/or symptoms of acute or chronic graft versus host disease, or c) participants must have appropriate hematology counts
- Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
- Investigational or anti-cancer therapy within 5 half-lives prior to the first dose of study drug
- History of significant renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObinutuzumabAlso: GA101; RO5072759Participants will receive IV infusion of obinutuzumab 100 milligrams (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 on Day 1 of Cycles 2-6. | Drug | Dose-Finding: Schedule A: Previously Untreated CLL, Dose-Finding: Schedule A: Relapsed/Refractory CLL, Dose-Finding: Schedule B: Previously Untreated CLL, Dose-Finding: Schedule B: Relapsed/Refractory CLL, Safety Expansion: Previously Untreated CLL, Safety Expansion: Relapsed/Refractory CLL |
| VenetoclaxAlso: ABT-199, GDC-0199Participants will receive multiple doses of venetoclax orally once daily. | Drug | Dose-Finding: Schedule A: Previously Untreated CLL, Dose-Finding: Schedule A: Relapsed/Refractory CLL, Dose-Finding: Schedule B: Previously Untreated CLL, Dose-Finding: Schedule B: Relapsed/Refractory CLL, Safety Expansion: Previously Untreated CLL, Safety Expansion: Relapsed/Refractory CLL |
Primary outcome
Percentage of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Schedule (Sch) A (Cycle 1 Day 1 to Day 21), Sch B (Cycle 1 Day 22 to Cycle 2 Day 28) (1 Cycle=28 days)
Maximum Tolerated Dose (MTD) of Venetoclax in Combination with Obinutuzumab
Time frame: Sch A (Cycle 1 Day 1 to Day 21), Sch B (Cycle 1 Day 22 to Cycle 2 Day 28) (1 Cycle=28 days)
17 secondary outcomes
Percentage of Participants with Adverse Events
Time frame: Baseline up to end of study (up to approximately 5 years and 5 months)
Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) to Obinutuzumab
Time frame: Baseline up to Cycle 6 (1 Cycle=28 days)
Area Under the Concentration-Time Curve (AUC) of Venetoclax
Time frame: Baseline up to Cycle 6 (1 Cycle=28 days)
Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax
Time frame: Baseline up to Cycle 6 (1 Cycle=28 days)
Maximal Plasma Concentration (Cmax) of Venetoclax
Time frame: Baseline up to Cycle 6 (1 Cycle=28 days)
Minimum Plasma Concentration (Cmin) of Venetoclax
Time frame: Baseline up to Cycle 6 (1 Cycle=28 days)
Cmax of Obinutuzumab
Time frame: Baseline up to Cycle 6 (1 Cycle=28 days)
Cmin of Obinutuzumab
Time frame: Baseline up to Cycle 6 (1 Cycle=28 days)
Percentage of Participants with Confirmed Complete Response (CR) as Determined by Standard CLL Response Criteria
Time frame: Baseline up to end of study (up to approximately 5 years and 5 months)
Percentage of Participants with Objective Response (Partial Response [PR] or CR [Including Cytopenic CR] as Determined by Standard CLL Response Criteria
Time frame: Baseline up to end of study (up to approximately 5 years and 5 months)
Duration of Objective Response as Determined by Standard CLL Response Criteria
Time frame: Baseline up to end of study (up to approximately 5 years and 5 months)
Overall Survival
Time frame: Baseline up to death or end of study (up to approximately 5 years and 5 months)
Progression-Free Survival as Determined by Standard CLL Response Criteria
Time frame: Baseline up to end of study (up to approximately 5 years and 5 months)
Change from Baseline in Number of B-Cells
Time frame: Baseline up to end of study (up to approximately 5 years and 5 months)
Change from Baseline in Number of T-Cells
Time frame: Baseline up to end of study (up to approximately 5 years and 5 months)
Change from Baseline in Number of Natural Killer (NK) Cells
Time frame: Baseline up to end of study (up to approximately 5 years and 5 months)
Change from Baseline in Serum Immunoglobulin Level
Time frame: Baseline up to end of study (up to approximately 5 years and 5 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Derived from this study: PubMed 35708885Samineni D, Gibiansky L, Wang B, Vadhavkar S, Rajwanshi R, Tandon M, Sinha A, Al-Sawaf O, Fischer K, Hallek M, Salem AH, Li C, Miles D. Pharmacokinetics and Exposure-Response Analysis of Venetoclax + Obinutuzumab in Chronic Lymphocytic Leukemia: Phase 1b Study and Phase 3 CLL14 Trial. Adv Ther. 2022 Aug;39(8):3635-3653. doi: 10.1007/s12325-022-02170-w. Epub 2022 Jun 16.
- Derived from this study: PubMed 30862645Flinn IW, Gribben JG, Dyer MJS, Wierda W, Maris MB, Furman RR, Hillmen P, Rogers KA, Iyer SP, Quillet-Mary A, Ysebaert L, Walter HS, Verdugo M, Klein C, Huang H, Jiang Y, Lozanski G, Pignataro DS, Humphrey K, Mobasher M, Kipps TJ. Phase 1b study of venetoclax-obinutuzumab in previously untreated and relapsed/refractory chronic lymphocytic leukemia. Blood. 2019 Jun 27;133(26):2765-2775. doi: 10.1182/blood-2019-01-896290. Epub 2019 Mar 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Obinutuzumab and Venetoclax in people with Lymphocytic Leukemia, Chronic, run by Genentech, Inc. at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Dose Limiting Toxicities (DLTs) (time frame: Schedule (Sch) A (Cycle 1 Day 1 to Day 21), Sch B (Cycle 1 Day 22 to Cycle 2 Day 28) (1 Cycle=28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01685892, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2020.