Lymphoma, Large B-Cell, DiffusePhase 1NCT02031419
Novel Combinations of CC-122, CC-223, CC-292, and Rituximab in Diffuse Large B-cell Lymphoma and Follicular Lymphoma
A Phase 1 study testing CC-122, CC-223 and Rituximab in people with Lymphoma, Large B-Cell, Diffuse, run by Celgene at 16 sites in 4 countries.
Trial summary
First study, at multiple clinical centers, exploring the effects of different combinations of compounds (CC-122, CC-223 ,CC-292 and rituximab) to treat Diffuse Large B Cell Lymphoma (DLBCL) and Follicular Lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Large B-Cell, Diffuse
- What is being tested?
- CC-122, CC-223 and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 16 sitesin 4 countries
- Study dates
- 18 Dec 2013to 12 Dec 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
- Men and women, 18 years or older, with histologically or cytologically-confirmed either:
- Chemo-refractory DLBCL (including transformed low grade lymphoma)
- Lenalidomide naïve; relapsed or refractory CD20-positive follicular lymphoma (Grade 1, 2, or 3a) following at least one prior standard systemic treatment regimen including systemic chemo-, immune-; or chemo-immunotherapy and at least one prior line of salvage therapy with no prior exposure to lenalidomide, or double-refractory FL participants with no prior exposure to lenalidomide (FL-1 cohort)
- Lenalidomide exposed: relapsed or refractory CD20-positive 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
- At least one site of measurable disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
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- Participants must have the following laboratory values:
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L or ≥ 1.0 x 109/L (with bone marrow involvement with DLBCL)
- Hemoglobin (Hgb) ≥ 8 g/dL.
- Potassium within normal limits
- Asparate 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.
- Estimated serum creatinine clearance of ≥ 50 mL/min
- Participants must have the following laboratory values:
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L without growth factor support for 7 days (14 days if participants received pegfilgrastim).
- Males enrolled into treatment arms receiving CC-122 must: Agree to abstain from donating sperm while taking IP and for at least 95 days following discontinuation of IP
Who cannot join
- Symptomatic central nervous system involvement.
- Known symptomatic acute or chronic pancreatitis.
- Persistent diarrhea or malabsorption despite medical management.
- Peripheral neuropathy ≥ grade 2
- Impaired cardiac function or clinically significant cardiac diseases
- Participants with diabetes on active treatment (for participants treated on CC-223 containing arms only)
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- Prior autologous stem cell transplant (ASCT) ≤ 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 4 weeks prior to starting study drugs, whichever is shorter.
- Participants who have undergone major surgery ≤ 2 weeks prior to starting study drugs.
- Women who are pregnant or breast feeding. Adults of reproductive potential not willing to employ two forms of birth control.
- Participants with known HIV infection, chronic active hepatitis B or C virus (HBV/HCV) infection.
- Participants with treatment-related myelodysplastic syndrome.
- History of concurrent second cancers requiring active, ongoing systemic treatment.
- Prior treatment with a dual mTORC1/mTORC2 inhibitor (CC-223 arms only) or BTK inhibitor (PCI-32765) (CC-292 arms only). [Prior treatment with rapamycin analogues, PI3K or AKT inhibitors, lenalidomide and rituximab are allowed].
Trial locations and contacts
16 sites in 4 countries.
16 sites in 4 countries
United States8 sites
Northwestern University
Chicago, Illinois, 60611
MD Anderson Cancer Center
Houston, Texas, 77030-400
Local Institution - 007
Madison, Wisconsin, 53792
Local Institution - 001
Nashville, Tennessee, 37203
Yale Cancer Center
New Haven, Connecticut, 06510
Mayo Clinic
Rochester, Minnesota, 55905
Stanford Cancer Center
Stanford, California, 94305
Local Institution - 005
Tampa, Florida, 33612
France3 sites
Local Institution - 102
Bordeaux, 33076
Local Institution - 101
Lyon, 69373
Local Institution - 100
Villejuif, 94805
Italy3 sites
Local Institution - 202
Milan, 20133
Local Institution - 200
Rozzano (MI), 20089
Local Institution - 201
Turin, 10126
Canada2 sites
Local Institution - 402
Edmonton, Alberta, T6G 1Z2
Local Institution - 400
Toronto, Ontario, M5G 2M9
About this study
Official title: A Phase 1B, Multi-Center, Open-Label Study of Novel Combinations of CC-122, CC-223, CC-292, and Rituximab in Diffuse Large B-Cell Lymphoma and Follicular Lymphoma
First study, at multiple clinical centers, exploring the effects of different combinations of compounds (CC-122, CC-223 ,CC-292 and rituximab) to treat Diffuse Large B Cell Lymphoma (DLBCL) and Follicular Lymphoma
Read the detailed description
Study CC-122-DLBCL-001 is a Phase 1b dose escalation and expansion clinical study of CC 122, CC-223 and CC-292 administered orally as doublets with or without rituximab, in participants with relapsed/refractory DLBCL who have failed standard therapy.
In expansion phase, selected combination will be administered to lenalidomide naïve FL participants and lenalidomide exposed FL participants in addition to relapsed/refractory DLBCL participants.
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Being tested
- CC-122, CC-223, Rituximab, CC-292
- Keywords
- CC-122, CC-223, CC-292, Rituximab, Lymphoma, Diffuse Large B-Cell Lymphoma, Lenalidomide naïve Follicular Lymphoma, Lenalidomide exposed Follicular Lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-122Drug
2mg or 3 mg administered orally once daily
CC-223Drug
20mg or 30mg administered orally once daily.
RituximabDrug
375 mg/m2 administered intravenously once every 28 days
CC-122Drug
2mg or 3mg administered orally once daily.
CC-292Drug
500 mg twice a day administered orally.
RituximabDrug
375 mg/m2 administered intravenously once every 28 days
CC-223Drug
20mg or 30mg per day administered orally daily.
CC-292Drug
500 mg twice a day administered orally.
RituximabDrug
375 mg/m2 administered intravenously once every 28 days
| Study group | Role | What they receive |
|---|---|---|
| CC-122 + CC-223 +/- rituximab | Experimental | CC-122 administered orally once daily at 2mg or 3 mg in combination with CC-223 administered orally once daily at 20mg or 30 mg with or without Rituximab administered by IV once every 28 days Receives: Drug: CC-122; Drug: CC-223; Drug: Rituximab |
| CC-122 + CC-292 +/- rituximab | Experimental | CC-122 administered orally once daily at 2mg or 3 mg in combination with CC-292 administered orally twice daily at 500 mg with or without Rituximab administered by IV once every 28 days Receives: Drug: CC-122; Drug: CC-292; Drug: Rituximab |
| CC-292 + CC-223 +/- rituximab | Experimental | CC-292 administered twice daily at 500 mg in combination with CC-223 administered orally once daily at 20mg or 30 mg with or without Rituximab administered by IV once every 28 days Receives: Drug: CC-223; Drug: CC-292; Drug: Rituximab |
| CC-122 + rituximab | Experimental | CC-122 administered orally once daily in combination with Rituximab. Receives: Drug: CC-122; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
To determine safety profiles and dose-limiting toxicities of study drug combinations using NCI CTCAE v4.
Measured: From the time of informed consent, throughout dosing period and for 28 days after the last dose of study drug.
Secondary outcomes (2)
Efficacy
Tumor response rates using Cheson Revised Response Criteria for Malignant Lymphoma
Measured: Every 2-3 months until proof of tumor progression
Pharmacokinetics - CC-223 and CC-292 interaction
Area under the plasma concentration-time curve
Measured: Day 1, Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study start18 Dec 2013
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
Why it stopped: Replaced with another clinical trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 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
- NCT02031419
- Sponsor's protocol ID
- CC-122-DLBCL-001
- Status last verified
- Jan 2024
- First submitted
- 7 Jan 2014
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B, Multi-Center, Open-Label Study of Novel Combinations of CC-122, CC-223, CC-292, and Rituximab in Diffuse Large B-Cell Lymphoma and Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT02031419
- Acronym / sponsor ID
- CC-122-DLBCL-001
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Keywords
- CC-122, CC-223, CC-292, Rituximab, Lymphoma, Diffuse Large B-Cell Lymphoma, Lenalidomide naïve Follicular Lymphoma, Lenalidomide exposed Follicular Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Replaced with another clinical trial.
- Enrolment
- 174 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2013 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 9 Jan 2014 (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.
First study, at multiple clinical centers, exploring the effects of different combinations of compounds (CC-122, CC-223 ,CC-292 and rituximab) to treat Diffuse Large B Cell Lymphoma (DLBCL) and Follicular Lymphoma
Detailed description
Study CC-122-DLBCL-001 is a Phase 1b dose escalation and expansion clinical study of CC 122, CC-223 and CC-292 administered orally as doublets with or without rituximab, in participants with relapsed/refractory DLBCL who have failed standard therapy.
In expansion phase, selected combination will be administered to lenalidomide naïve FL participants and lenalidomide exposed FL participants in addition to relapsed/refractory DLBCL participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CC-122 + CC-223 +/- rituximab | Experimental | Drug: CC-122, Drug: CC-223, Drug: RituximabCC-122 administered orally once daily at 2mg or 3 mg in combination with CC-223 administered orally once daily at 20mg or 30 mg with or without Rituximab administered by IV once every 28 days |
| CC-122 + CC-292 +/- rituximab | Experimental | Drug: CC-122, Drug: CC-292, Drug: RituximabCC-122 administered orally once daily at 2mg or 3 mg in combination with CC-292 administered orally twice daily at 500 mg with or without Rituximab administered by IV once every 28 days |
| CC-292 + CC-223 +/- rituximab | Experimental | Drug: CC-223, Drug: CC-292, Drug: RituximabCC-292 administered twice daily at 500 mg in combination with CC-223 administered orally once daily at 20mg or 30 mg with or without Rituximab administered by IV once every 28 days |
| CC-122 + rituximab | Experimental | Drug: CC-122, Drug: RituximabCC-122 administered orally once daily in combination with Rituximab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Men and women, 18 years or older, with histologically or cytologically-confirmed either:
- At least one site of measurable disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
- Participants must have the following laboratory values:
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L or ≥ 1.0 x 109/L (with bone marrow involvement with DLBCL)
Key exclusion criteria (15 listed)
- Symptomatic central nervous system involvement.
- Known symptomatic acute or chronic pancreatitis.
- Persistent diarrhea or malabsorption despite medical management.
- Peripheral neuropathy ≥ grade 2
- Impaired cardiac function or clinically significant cardiac diseases
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 |
|---|---|---|
| CC-1222mg or 3 mg administered orally once daily | Drug | CC-122 + CC-223 +/- rituximab, CC-122 + rituximab |
| CC-22320mg or 30mg administered orally once daily. | Drug | CC-122 + CC-223 +/- rituximab |
| Rituximab375 mg/m2 administered intravenously once every 28 days | Drug | CC-122 + CC-223 +/- rituximab, CC-122 + rituximab |
| CC-1222mg or 3mg administered orally once daily. | Drug | CC-122 + CC-292 +/- rituximab |
| CC-292500 mg twice a day administered orally. | Drug | CC-122 + CC-292 +/- rituximab |
| Rituximab375 mg/m2 administered intravenously once every 28 days | Drug | CC-122 + CC-292 +/- rituximab |
| CC-22320mg or 30mg per day administered orally daily. | Drug | CC-292 + CC-223 +/- rituximab |
| CC-292500 mg twice a day administered orally. | Drug | CC-292 + CC-223 +/- rituximab |
| Rituximab375 mg/m2 administered intravenously once every 28 days | Drug | CC-292 + CC-223 +/- rituximab |
Primary outcome
Safety
Time frame: From the time of informed consent, throughout dosing period and for 28 days after the last dose of study drug.
To determine safety profiles and dose-limiting toxicities of study drug combinations using NCI CTCAE v4.
2 secondary outcomes
Efficacy
Time frame: Every 2-3 months until proof of tumor progression
Pharmacokinetics - CC-223 and CC-292 interaction
Time frame: Day 1, Day 15
Results and safety
The study was stopped early (reason given: Replaced with another clinical trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- BMS Clinical Trial InformationLink 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
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CC-122, CC-223 and Rituximab in people with Lymphoma, Large B-Cell, Diffuse, run by Celgene at 16 sites in 4 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 16 inclusion and 15 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: stopped early, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, France, Italy, Canada. 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 was stopped early (reason given: Replaced with another clinical trial.). Results are not available in the source record.
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?
Safety (time frame: From the time of informed consent, throughout dosing period and for 28 days after the last dose of study drug.). 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 18 Jan 2024.