Chronic Lymphocytic LeukemiaPhase 2NCT01868893
An Expanded Access, Open-Label Study of Obinutuzumab (GA101) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia
A Phase 2 study testing Obinutuzumab and Chlorambucil in people with Chronic Lymphocytic Leukemia, run by Genentech, Inc. at 19 sites in United States.
Trial summary
This is a multicenter, open-label, single-arm, expanded access treatment study designed to provide obinutuzumab to patients with previously untreated Chronic Lymphocytic Leukemia (CLL) in combination with chlorambucil and to evaluate the safety and efficacy of obinutuzumab administered in combination with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Obinutuzumab and Chlorambucil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 19 sitesUnited States
- Study dates
- Aug 2013to Jan 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Confirmed diagnosis of CD20-positive CLL (per IWCLL guidelines, Hallek et al 2008)
- Previously untreated CLL requiring treatment according to the IWCLL guidelines (Hallek et al 2008), as assessed by the investigator
- Adequate baseline bone marrow function unless it due to underlying CLL disease No previous treatment for CLL by chemotherapy, radiotherapy, or immunotherapy
- Patients who are not appropriate to receive more intensive chemotherapy in the judgment of the investigator
- Life expectancy of > 6 months
Who cannot join
- Treatment with any other investigational agent or participation in another clinical trial within 28 days prior to the start of Cycle 1
- Transformation of CLL to aggressive B-cell malignancy History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
- Known hypersensitivity to chlorambucil or any of its excipients
- History of other malignancy that could affect compliance with the protocol or interpretation of results Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (related to the completion of the course of antibiotics) within 4 weeks before the start of Cycle 1
- Major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
- Known infection with human immunodeficiency virus (HIV) or Human T-Cell Leukemia Virus 1 (HTLV-1) seropositive status
Show all 11Show fewer
- Positive hepatitis serology
- Women who are pregnant or lactating
- Fertile men or women of childbearing potential unless 1) surgically sterile or 2) using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly
- Effective contraception is required while receiving obinutuzumab. For women, effective contraception is required to continue for >= 12 months after the last dose of obinutuzumab. For men, effective contraception is required to continue for 6 months after the last dose of chlorambucil treatment.
- Vaccination with a live vaccine a minimum of 28 days prior to the start of Cycle 1
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Peachtree Hematology & Oncology Consultants, Pc
Atlanta, Georgia, 30318
Charleston Hematology Oncology
Charleston, South Carolina, 29414
Kootenai Cancer Center
Coeur d'Alene, Idaho, 83814
Mark H. Zangmeister Center
Columbus, Ohio, 43219
San Juan Oncology Associates
Farmington, New Mexico, 87401
Illinois Cancer Care, P.C. - Galesburg
Galesburg, Illinois, 61401
Center for Cancer Care
Goshen, Indiana, 46526
Vince Lombardi Cancer Clinic Pharmacy
Green Bay, Wisconsin, 54311
Clearview Cancer Institute
Huntsville, Alabama, 35805
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Joliet Oncology Hematology Associates, Ltd.
Joliet, Illinois, 60435
University of California San Diego
La Jolla, California, 92093
Horizon Oncology Research, Inc.
Lafayette, Indiana, 47905
Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, 30060
Illinois Cancer Care
Peoria, Illinois, 61615
Bay Area Cancer Research Group, LLC
Pleasant Hill, California, 94523
Highlands Oncology Group
Rogers, Arkansas, 72758
Cancer Center of Central Conn.
Southington, Connecticut, 06489
Northwest Medical Specialties
Tacoma, Washington, 98405
About this study
This is a multicenter, open-label, single-arm, expanded access treatment study designed to provide obinutuzumab to patients with previously untreated Chronic Lymphocytic Leukemia (CLL) in combination with chlorambucil and to evaluate the safety and efficacy of obinutuzumab administered in combination with chlorambucil. This study will enroll patients with previously untreated CD20-positive CLL requiring treatment according to the IWCLL guidelines (Hallek et al 2008), as assessed by the investigator.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Obinutuzumab, Chlorambucil
- 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 RO 5072759, GA101
ChlorambucilDrug
| Study group | Role | What they receive |
|---|---|---|
| Obinutuzumab + Chlorambucil | Experimental | Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles). Receives: Drug: Obinutuzumab; Drug: Chlorambucil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Received Obinutuzumab and Chlorambucil in the Study
Number of participants who received obinutuzumab and chlorambucil in the study are presented in the below table.
Measured: Cycles 1 to 6 (28-day cycles)
Secondary outcomes (2)
Number of Participants With Adverse Events (AEs), AEs of Grade 3 and Above Severity, AEs of Special Interest (AESI), AEs Leading to Obinutuzumab Discontinuation or Dose Delays, Serious Adverse Events (SAEs), and Death
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 was used for grading the AEs. According to NCI CTCAE, Grade 3 = severe or medically significant but not immediately life threatening; Grade 4 = life-threatening consequences, urgent intervention indicated, and Grade 5 = death. AESIs included all tumor lysis syndrome, serious infections, serious infusion-related reactions (IRR), and hepatitis B reactivation. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
Measured: Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
Number of Participants With Objective Response
Objective response is defined as either complete response [CR], complete response with incomplete recovery [CRi], or partial response [PR] as determined by the treating physician's standard practice at the end of treatment or premature discontinuation from study per the International Workshop on Chronic Lymphocytic Leukemia Criteria (iwCLL criteria). Patients who have not achieved a CR or a PR, and who have not exhibited progressive disease, will be considered to have stable disease (which is equivalent to a nonresponse).
Measured: Up to end of treatment or premature discontinuation from study (up to 7 months from Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startAug 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Lymphocytic LeukemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868893
- Sponsor's protocol ID
- ML28979
- Status last verified
- Mar 2017
- First submitted
- 29 May 2013
- Last updated
- 17 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expanded Access, Open-Label Study of Obinutuzumab (GA101) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT01868893
- Acronym / sponsor ID
- ML28979
- Conditions
- Chronic Lymphocytic Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Posted 7 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open-label, single-arm, expanded access treatment study designed to provide obinutuzumab to patients with previously untreated Chronic Lymphocytic Leukemia (CLL) in combination with chlorambucil and to evaluate the safety and efficacy of obinutuzumab administered in combination with chlorambucil. This study will enroll patients with previously untreated CD20-positive CLL requiring treatment according to the IWCLL guidelines (Hallek et al 2008), as assessed by the investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obinutuzumab + Chlorambucil | Experimental | Drug: Obinutuzumab, Drug: ChlorambucilObinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of CD20-positive CLL (per IWCLL guidelines, Hallek et al 2008)
- Previously untreated CLL requiring treatment according to the IWCLL guidelines (Hallek et al 2008), as assessed by the investigator
- Adequate baseline bone marrow function unless it due to underlying CLL disease No previous treatment for CLL by chemotherapy, radiotherapy, or immunotherapy
- Patients who are not appropriate to receive more intensive chemotherapy in the judgment of the investigator
- Life expectancy of > 6 months
Key exclusion criteria (11 listed)
- Treatment with any other investigational agent or participation in another clinical trial within 28 days prior to the start of Cycle 1
- Transformation of CLL to aggressive B-cell malignancy History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
- Known hypersensitivity to chlorambucil or any of its excipients
- History of other malignancy that could affect compliance with the protocol or interpretation of results Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (related to the completion of the course of antibiotics) within 4 weeks before the start of Cycle 1
- Major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
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: RO 5072759, GA101 | Drug | Obinutuzumab + Chlorambucil |
| Chlorambucil | Drug | Obinutuzumab + Chlorambucil |
Primary outcome
Number of Participants Who Received Obinutuzumab and Chlorambucil in the Study
Time frame: Cycles 1 to 6 (28-day cycles)
Number of participants who received obinutuzumab and chlorambucil in the study are presented in the below table.
2 secondary outcomes
Number of Participants With Adverse Events (AEs), AEs of Grade 3 and Above Severity, AEs of Special Interest (AESI), AEs Leading to Obinutuzumab Discontinuation or Dose Delays, Serious Adverse Events (SAEs), and Death
Time frame: Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
Number of Participants With Objective Response
Time frame: Up to end of treatment or premature discontinuation from study (up to 7 months from Day 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Obinutuzumab and Chlorambucil in people with Chronic Lymphocytic Leukemia, run by Genentech, Inc. at 19 sites in United States.
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 11 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 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Received Obinutuzumab and Chlorambucil in the Study (time frame: Cycles 1 to 6 (28-day cycles)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2017.