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Novel Combinations of CC-122, CC-223, CC-292, and Rituximab in Diffuse Large B-cell Lymphoma and Follicular Lymphoma

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Celgene

Status and phase

Terminated
Phase 1

Conditions

Lymphoma, Large B-Cell, Diffuse

Treatments

Drug: CC-122
Drug: CC-292
Drug: Rituximab
Drug: CC-223

Study type

Interventional

Funder types

Industry

Identifiers

NCT02031419
CC-122-DLBCL-001

Details and patient eligibility

About

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

Full 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.

Enrollment

174 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Men and women, 18 years or older, with histologically or cytologically-confirmed either:

    1. Chemo-refractory DLBCL (including transformed low grade lymphoma)
    2. 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)
    3. 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.

  • 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

Exclusion criteria

  • 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)
  • 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 design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

174 participants in 4 patient groups

CC-122 + CC-223 +/- rituximab
Experimental group
Description:
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
Treatment:
Drug: CC-122
Drug: Rituximab
Drug: Rituximab
Drug: CC-223
Drug: Rituximab
Drug: CC-122
Drug: CC-223
CC-122 + CC-292 +/- rituximab
Experimental group
Description:
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
Treatment:
Drug: CC-122
Drug: CC-292
Drug: Rituximab
Drug: Rituximab
Drug: Rituximab
Drug: CC-122
Drug: CC-292
CC-292 + CC-223 +/- rituximab
Experimental group
Description:
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
Treatment:
Drug: CC-292
Drug: Rituximab
Drug: Rituximab
Drug: CC-223
Drug: Rituximab
Drug: CC-292
Drug: CC-223
CC-122 + rituximab
Experimental group
Description:
CC-122 administered orally once daily in combination with Rituximab.
Treatment:
Drug: CC-122
Drug: Rituximab
Drug: Rituximab
Drug: Rituximab
Drug: CC-122

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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