Lymphoma, Large B-Cell, DiffusePhase 1NCT02417285
A Phase 1b Open-label Study to Evaluate the Safety and Efficacy of CC-122 With Obinutuzumab (GA101) in Relapsed/Refractory DLBCL and iNHL.
A Phase 1 study testing Obinutuzumab and CC-122 in people with Lymphoma, Large B-Cell, Diffuse and Lymphoma, Non-Hodgkin, run by Celgene at 8 sites in 3 countries.
Trial summary
CC-122-NHL-001 study is a multicenter, open-label, phase Ib study with dose escalation and expansion parts. It evaluates the safety, tolerability and clinical pharmacokinetics of CC-122 in combination with obinutuzumab (GA101). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin
- What is being tested?
- Obinutuzumab and CC-122
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 22 May 2015to 28 Sep 2023
- 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
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
- ≥ 18 years of age or older at the time of signing the informed consent document.
- Entry Criteria Specific for Dose-Escalation Phase (Part A)
- Subjects with CD20 positive, histologically or cytologically-confirmed, diffuse large B-cell lymphoma (DLBCL)(including transformed low grade lymphoma) who have relapsed or refractory disease following at least two prior standard treatment regimens (eg, R-CHOP or similar first-lineregimen and at least one second-line salvage regimen) and/or autologous stem cell transplant (ASCT) in chemotherapy-sensitive patients, with the following ASCT
- EXCEPTIONS:
- Subjects in the pre-ASCT setting with poor prognosis, defined as primary refractory disease, that have relapsed within 12 months following first-line treatment; "double-hit" lymphomas with Bcl-2/Myc gene rearrangements or, overexpression or high IPI score (2,3) at relapse.
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- Subjects refusing ASCT or for whom ASCT is not appropriate based on the Investigator's judgment.
- Entry Criteria Specific for Dose-Expansion Phase (Part B)
- Subjects with CD20 positive, histologically confirmed (by WHO 2008 classification [Jaffe, 2009]), FL (Grade 1, 2, or 3a) who have relapsed or refractory disease following at least one prior standard systemic treatment regimen including systemic chemo-, immune-, or chemoimmunotherapy.
- Systemic therapy includes treatments such as rituximab monotherapy, chemotherapy given with or without rituximab, radio-immunoconjugates such as 90Y-ibritumomab tiuxetan and 1311-tositumomab. Systemic therapy does not include, for example, H. pylori eradication or antibiotic treatment.
- Lenalidomide naïve
- Relapsed or refractory follicular lymphoma (Grade 1, 2, or 3a) following at least one prior standard systemic treatment regimen including systemic chemo-, immune-, or chemoimmunotherapy with no prior exposure to lenalidomide (FL-1 cohort)
- Lenalidomide exposed
- Relapsed or refractory follicular lymphoma (Grade 1, 2, or 3a) previously treated with at least two cycles of lenalidomide-containing regimen (FL-2 cohort), either as a single agent or in combination, and experienced outcomes to the lenalidomide treatment as follows:
- Early relapse after lenalidomide treatment: Subjects with relapse within one year of last dose of lenalidomide (or a lenalidomide-containing regimen) following initial response of Complete Response (CR) to lenalidomide (or a lenalidomide-containing regimen) Early progression after lenalidomide treatment: Subjects with Progressive Disease (PD) within one year of last dose of lenalidomide (or lenalidomide-containing regimen) following initial response of partial response (PR) to lenalidomide (or a lenalidomide-containing regimen) Disease refractory to lenalidomide: Subjects with best response of stable disease (SD) or PD while on lenalidomide (or lenalidomide-containing regimen) without any documented response of PR or better during treatment with lenalidomide (or a lenalidomide-containing regimen) Lenalidomide or lenalidomide - containing regimen does not need to be the immediate prior regimen received by the subject to be eligible for entry.
- Entry Criteria that apply to both Part A and Part B
- Subjects with CD20 positive, histologically confirmed (by WHO 2008 classification [Jaffe, 2009]), FL (Grade 1, 2, or 3a) who have relapsed or refractory disease following at least one prior standard systemic treatment regimen including systemic chemo-, immune-, or chemoimmunotherapy.
- Systemic therapy includes treatments such as rituximab monotherapy, chemotherapy given with or without rituximab, radio-immunoconjugates such as 90Y-ibritumomab tiuxetan and 1311-tositumomab. Systemic therapy does not include, for example, H. pylori eradication or antibiotic treatment.
- Lenalidomide naïve
- Relapsed or refractory follicular lymphoma (Grade 1, 2, or 3a) following at least one prior standard systemic treatment regimen including systemic chemo-, immune-, or chemoimmunotherapy with no prior exposure to lenalidomide (FL 2 cohort). In addition, subjects must have received one prior line of salvage therapy, unless ineligible for autologous transplant.
- Lenalidomide exposed
- Relapsed or refractory follicular lymphoma (Grade 1, 2, or 3a) previously treated with at least two cycles of lenalidomide-containing regimen (FL-1 cohort), either as a single agent or in combination, and experienced outcomes to the lenalidomide treatment as follows:
- Early relapse after lenalidomide treatment: Subjects with relapse within one year of last dose of lenalidomide (or a lenalidomide-containing regimen) following initial response of Complete Response (CR) to lenalidomide (or a lenalidomide-containing regimen) Early progression after lenalidomide treatment: Subjects with Progressive Disease (PD) within one year of last dose of lenalidomide (or lenalidomide-containing regimen) following initial response of partial response (PR) to lenalidomide (or a lenalidomide-containing regimen) Disease refractory to lenalidomide: Subjects with best response of stable disease (SD) or PD while on lenalidomide (or lenalidomide-containing regimen) without any documented response of PR or better during treatment with lenalidomide (or a lenalidomide-containing regimen) Lenalidomide or lenalidomide - containing regimen does not need to be the immediate prior regimen received by the subject to be eligible for entry.
- Entry Criteria that apply to both Part A and Part B
- Bi-dimensionally measurable disease on cross sectional imaging by Computed Tomagraphy (CT) or Magnetic resonance imaging (MRI) with at least one lesion > 1.5 cm in the transverse diameter, as defined by the International Working Group (IWG) NHL criteria
- Measurable disease cannot be previously irradiated.
- ECOG PS (Eastern Cooperative Oncology Group Scale of Performance Status) of 0 to 1.
- Subjects must have the following laboratory values at screening:
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L without growth factor support for 7 days (14 days if subject received pegfilgrastim).
- Hemoglobin (Hgb) ≥ 8 g/dL.
- Platelets (plt) ≥ 50 x 109/L without transfusion for 7 days.
- Potassium within normal limits or corrected with supplements.
- Aspartate aminotransferase/Serum glutamic-oxaloacetic transaminase (AST/SGOT) and Alanine aminotransferase / Serum glutamic pyruvic transaminase (ALT/SGPT) ≤ 2.5 x Upper Limit of Normal (ULN) or ≤ 5.0 x ULN if liver tumor is present.
- Serum bilirubin ≤1.5 x ULN except in cases of Gilberts Syndrome, then ≤ 2.0 x ULN
- Estimated serum creatinine clearance of ≥ 60 mL/min using the Cockcroft-Gault equation.
- Per the Pregnancy Prevention Risk Management Plan (PPRMP)
- Females of childbearing potential (FCBP) must undergo pregnancy testing based on the frequency outlined in PPRMP and pregnancy results must be negative.
- Unless practicing complete abstinence from heterosexual intercourse, sexually active FCBP must agree to use adequate contraceptive methods as specified in PPRMP.
- Complete abstinence is only acceptable in cases where this is the preferred and usual lifestyle of the subject.
- Periodic abstinence (calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable.
- Males (including those who have had a vasectomy) must use barrier contraception (condoms) when engaging in sexual activity with FCBP as specified in PPRMP.
- Males must agree not to donate semen or sperm for the duration specified in PPRMP.
- All subjects must:
- Understand that the study drugs could have a potential teratogenic risk. Agree to abstain from donating blood while taking study drugs and following discontinuation of investigational product.
- Agree not to share study drugs with another person.
- Other than the subject, FCBP and males able to father a child should not handle the study drugs or touch the capsules, unless gloves are worn.
- Be counseled about pregnancy precautions and risks of fetal exposure (refer to PPRMP, Appendix B)
- Able to adhere to the study visit schedule and other protocol requirements.
Who cannot join
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- Any condition that confounds the ability to interpret data from the study.
- Symptomatic central nervous system involvement.
- Any history of progressive multifocal leukoencephalopathy (PML).
- Known symptomatic acute or chronic pancreatitis.
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- Persistent diarrhea or malabsorption ≥ NCI CTCAE Grade 2, despite medical management.
- Peripheral neuropathy ≥ NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) Grade 2
- Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- LVEF (left ventricular ejection fraction) < 45% as determined by MUGA (multi-gated acquisition scan) or ECHO (echocardiogram).
- Complete left bundle branch or bifascicular block.
- Congenital long QT syndrome.
- Persistent or clinically meaningful ventricular arrhythmias.
- QTcF > 460 msec on Screening ECG (electrocardiogram) (mean of triplicate recordings as assessed by central read).
- Unstable angina pectoris or myocardial infarction ≤ 6 months prior to starting study drugs.
- Troponin T value > 0.4 ng/mL or BNP > 300 pg/mL
- Subjects with baseline troponin T > ULN or BNP > 100 pg/mL are eligible but must have a cardiologist evaluation prior to enrollment in the trial for baseline assessment and optimization of cardioprotective therapy.
- Prior ASCT (autologous stem cell transplant) ≤ 3 months before first dose.
- Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning.
- Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 1 month prior to starting study drugs, whichever is shorter
- Prior radiotherapy within 1 month prior to starting study drugs.
- A major surgery ≤ 2 weeks prior to starting study drugs. Subjects must have recovered from any effects of recent surgery or therapy that might confound the safety evaluation of study drug.
- Prior treatment with CC-122
- History of severe allergic or anaphylactic reactions to humanized monoclonal antibodies.
- Allergic to any excipients in obinutuzumab.
- Known human immunodeficiency virus (HIV) infection.
- Known chronic active hepatitis B or C virus (HBV, HCV) infection.
- Subjects who are seropositive due to HBV vaccination are eligible.
- Subjects who have no active viral infection and are under adequate prophylactics against HBV re-activation are eligible.
- Need for current chronic systemic corticosteroid therapy (≥ 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids).
- Stable use of inhaled corticosteroids is allowed.
- Treatment-related myelodysplastic syndrome.
- Prior history of secondary malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥ 1 year prior to starting study drugs.
- Prior immunization with live virus vaccines (within 3 months prior to starting study drug) or anticipated immunization with live virus vaccines during the duration of the study.
- Pregnant or nursing females.
- Unwilling or unable to comply with the protocol, in the opinion of the Investigator.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
France4 sites
Local Institution - 105
Borddeaux Cedex, 33076
Local Institution - 102
Marseille, 13273
Local Institution - 103
Pierre-Bénite, 69495
Local Institution - 101
Villejuif, 94805
Italy2 sites
Local Institution - 301
Bologna, 40138
Local Institution - 302
Torino, 10126
Netherlands2 sites
Local Institution - 201
Amsterdam, 1105
Local Institution - 202
Rotterdam, 3075 EA
About this study
Official title: A Phase 1b Open-label Study to Evaluate the Safety and Efficacy of CC-122 in Combination With Obinutuzumab (GA101) in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma and Indolent Non-Hodgkin's Lymphoma
CC-122-NHL-001 study is a multicenter, open-label, phase Ib study with dose escalation and expansion parts. It evaluates the safety, tolerability and clinical pharmacokinetics of CC-122 in combination with obinutuzumab (GA101). The study is also assessing the preliminary efficacy of the combination as well as pharmacodynamic and tumor biomarkers as exploratory objectives. In the dose escalation part, the safety and tolerability of increasing doses of CC-122 administered with a fixed dose of obinutuzumab will be administered to identify the maximum tolerated dose. In the dose expansion part, more patients will be enrolled at a CC-122 dose selected from the escalation part of the study in combination with fixed dose obinutuzumab to further study safety and efficacy.
Read the detailed description
The one or two cohorts during the dose expansion phase (Part B) will enroll subjects with relapsed or refractory follicular lymphoma (FL) who were either refractory to or relapsed after treatment with a lenalidomide-containing regimen (FL-1 cohort) or never been exposed to lenalidomide (FL-2 cohort). The FL-1 and FL-2 cohorts will enroll up to 20 and/or up to 30 subjects, respectively.
- Being tested
- Obinutuzumab, CC-122
- Keywords
- Non-Hodgkin's Lymphoma, Diffused Large B-Cell Lymphoma, Phase 1B, Open-Label, Safety and Efficacy, CC-122, Obinutuzumab, GA101, Relapsed, Refractory
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObinutuzumabDrug
Also called GA-101
1000 mg administered IV on Days 2, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 though 8.
CC-122Drug
CC-122 1mg, 2mg, 3mg, 4mg or 5mg administered orally once daily on a 5/7-day schedule in each 28-day cycle. In addition, subjects will be enrolled on the CC-122 formulated capsule (F6) and evaluated for safety and tolerability in combination with GA101 (Obinituzumab) in a separate cohort. The CC-122 dose will be escalated until the MTD is established on the CC-122 formulated capsule (F6) in combination with GA101 (Obinituzumab).
| Study group | Role | What they receive |
|---|---|---|
| CC-122 in combination with Obinutuzumab | Experimental | CC-122 will be administered orally QD starting on Day 1 for 5 consecutive days followed by 2 days off study drug every 7 days (5/7-day schedule) in each 28-day cycle in combination with Obinutuzumab administered as an intravenous (IV) infusion at a dose of 1000 mg on Days 2, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 through 8. Receives: Drug: Obinutuzumab; Drug: CC-122 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
Number of participants with adverse events
Measured: Approximately 6 years
Secondary outcomes (9)
Tumor Response
Percentage of subjects with complete response (CR) or partial response (PR) Tumor response will be determined by the Investigator, based on modification of the modified International Working Group (IWG) Response Criteria for Malignant Lymphoma (Cheson,2007) criteria, and summarized using frequency tabulation by dose cohort and tumor type.
Measured: Approximately 6 years
Response Duration
Duration from the time when criteria for response (CR or PR) are met to disease relapse/progression using modified IWG evaluation criteria.
Measured: Approximately 6 years
Progression-free Survival (PFS)
Number of participants who survive without disease progression/relapse (using modified IWG evaluation criteria) or death as a result of any cause and time from the first dose date to disease progression/relapse or death, whichever occurs first
Measured: Approximately 6 years
Pharmacokinetics - Cmax
Maximum Observed Concentration in plasma
Measured: up to 8 months
Pharmacokinetics AUC
Area under the Concentration-time Curve
Measured: Up to 8 months
Pharmacokinetics Tmax
Time to Maximum Concentration
Measured: Up to 8 months
Pharmacokinetics T1/2
Terminal half-life (t1/2)
Measured: Up to 8 months
Pharmacokinetics - CL/F
Apparent total body clearance
Measured: Up to 8 months
Pharmacokinetics - Vz/f
Apparent volume of distribution
Measured: Up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study start22 May 2015
- Primary completion27 May 2019
- Study completion28 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Large B-Cell, DiffuseStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417285
- Sponsor's protocol ID
- CC-122-NHL-001
- Status last verified
- Oct 2023
- First submitted
- 10 Apr 2015
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Michot JM, Bouabdallah R, Vitolo U, Doorduijn JK, Salles G, Chiappella A, Zinzani PL, Bijou F, Kersten MJ, Sarmiento R, Mosulen S, Mendez C, Uttamsingh S, Pourdehnad M, Hege K, Chen T, Klein C, Hagner PR, Nikolova Z, Ribrag V. Avadomide plus obinutuzumab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (CC-122-NHL-001): a multicentre, dose escalation and expansion phase 1 study. Lancet Haematol. 2020 Sep;7(9):e649-e659. doi: 10.1016/S2352-3026(20)30208-8. Epub 2020 Aug 3.
PubMed 32758434
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Open-label Study to Evaluate the Safety and Efficacy of CC-122 in Combination With Obinutuzumab (GA101) in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma and Indolent Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT02417285
- Acronym / sponsor ID
- CC-122-NHL-001
- Keywords
- Non-Hodgkin's Lymphoma, Diffused Large B-Cell Lymphoma, Phase 1B, Open-Label, Safety and Efficacy, CC-122, Obinutuzumab, GA101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 22 May 2015 (actual)
- Primary completion
- 27 May 2019 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 15 Apr 2015 (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.
CC-122-NHL-001 study is a multicenter, open-label, phase Ib study with dose escalation and expansion parts. It evaluates the safety, tolerability and clinical pharmacokinetics of CC-122 in combination with obinutuzumab (GA101). The study is also assessing the preliminary efficacy of the combination as well as pharmacodynamic and tumor biomarkers as exploratory objectives. In the dose escalation part, the safety and tolerability of increasing doses of CC-122 administered with a fixed dose of obinutuzumab will be administered to identify the maximum tolerated dose. In the dose expansion part, more patients will be enrolled at a CC-122 dose selected from the escalation part of the study in combination with fixed dose obinutuzumab to further study safety and efficacy.
Detailed description
The one or two cohorts during the dose expansion phase (Part B) will enroll subjects with relapsed or refractory follicular lymphoma (FL) who were either refractory to or relapsed after treatment with a lenalidomide-containing regimen (FL-1 cohort) or never been exposed to lenalidomide (FL-2 cohort). The FL-1 and FL-2 cohorts will enroll up to 20 and/or up to 30 subjects, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CC-122 in combination with Obinutuzumab | Experimental | Drug: Obinutuzumab, Drug: CC-122CC-122 will be administered orally QD starting on Day 1 for 5 consecutive days followed by 2 days off study drug every 7 days (5/7-day schedule) in each 28-day cycle in combination with Obinutuzumab administered as an intravenous (IV) infusion at a dose of 1000 mg on Days 2, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 through 8. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (48 listed)
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
- ≥ 18 years of age or older at the time of signing the informed consent document.
- Entry Criteria Specific for Dose-Escalation Phase (Part A)
- Subjects with CD20 positive, histologically or cytologically-confirmed, diffuse large B-cell lymphoma (DLBCL)(including transformed low grade lymphoma) who have relapsed or refractory disease following at least two prior standard treatment regimens (eg, R-CHOP or similar first-lineregimen and at least one second-line salvage regimen) and/or autologous stem cell transplant (ASCT) in chemotherapy-sensitive patients, with the following ASCT
- Entry Criteria Specific for Dose-Expansion Phase (Part B)
Key exclusion criteria (36 listed)
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- Any condition that confounds the ability to interpret data from the study.
- Symptomatic central nervous system involvement.
- Any history of progressive multifocal leukoencephalopathy (PML).
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: GA-1011000 mg administered IV on Days 2, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 though 8. | Drug | CC-122 in combination with Obinutuzumab |
| CC-122CC-122 1mg, 2mg, 3mg, 4mg or 5mg administered orally once daily on a 5/7-day schedule in each 28-day cycle. In addition, subjects will be enrolled on the CC-122 formulated capsule (F6) and evaluated for safety and tolerability in combination with GA101 (Obinituzumab) in a separate cohort. The CC-122 dose will be escalated until the MTD is established on the CC-122 formulated capsule (F6) in combination with GA101 (Obinituzumab). | Drug | CC-122 in combination with Obinutuzumab |
Primary outcome
Adverse Events (AEs)
Time frame: Approximately 6 years
Number of participants with adverse events
9 secondary outcomes
Tumor Response
Time frame: Approximately 6 years
Response Duration
Time frame: Approximately 6 years
Progression-free Survival (PFS)
Time frame: Approximately 6 years
Pharmacokinetics - Cmax
Time frame: up to 8 months
Pharmacokinetics AUC
Time frame: Up to 8 months
Pharmacokinetics Tmax
Time frame: Up to 8 months
Pharmacokinetics T1/2
Time frame: Up to 8 months
Pharmacokinetics - CL/F
Time frame: Up to 8 months
Pharmacokinetics - Vz/f
Time frame: Up to 8 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 23 Oct 2023.
- Derived from this study: PubMed 32758434Michot JM, Bouabdallah R, Vitolo U, Doorduijn JK, Salles G, Chiappella A, Zinzani PL, Bijou F, Kersten MJ, Sarmiento R, Mosulen S, Mendez C, Uttamsingh S, Pourdehnad M, Hege K, Chen T, Klein C, Hagner PR, Nikolova Z, Ribrag V. Avadomide plus obinutuzumab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (CC-122-NHL-001): a multicentre, dose escalation and expansion phase 1 study. Lancet Haematol. 2020 Sep;7(9):e649-e659. doi: 10.1016/S2352-3026(20)30208-8. Epub 2020 Aug 3.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Obinutuzumab and CC-122 in people with Lymphoma, Large B-Cell, Diffuse and Lymphoma, Non-Hodgkin, run by Celgene at 8 sites in 3 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 48 inclusion and 36 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 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Italy, Netherlands. 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?
Adverse Events (AEs) (time frame: Approximately 6 years). 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 NCT02417285, which also lists 1 linked publication.
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 23 Oct 2023; AzTrials last refreshed its copy on 27 Oct 2026.