Trial Search Results

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

The purpose of this study is determine the safety and tolerability of CC-122, CC-223 and CC-292 when administered orally as doublets, and as triplets in combination with rituximab. CC-122 will also be administered only with rituximab.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Celgene

Intervention(s):

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

Phase:

Phase 1

Eligibility


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 subjects 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.

   - Subjects 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

   - Subjects 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 subject received pegfilgrastim).

   - Males enrolled into treatment arms receiving CC-122 must: Agree to abstain from
   donating sperm while taking IP and for at least 3 months 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

   - Subjects with diabetes on active treatment (for subjects 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.

   - Subjects 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.

   - Subjects with known HIV infection, chronic active hepatitis B or C virus (HBV/HCV)
   infection.

   - Subjects 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].

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting