Non Hodgkin Lymphoma Clinical Trial

Study of CC-122 to Evaluate the Safety, Tolerability, and Effectiveness for Patients With Advanced Solid Tumors, Non-Hodgkin’s Lymphoma, or Multiple Myeloma

Summary

The main purpose of this first in human study with CC-122 is to assess the safety and action of a new class of experimental drug (Pleiotropic Pathway Modulator) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dosing level and regimen for later-stage clinical trials.

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Full Description

This trial is enrolling additional Multiple Myeloma (MM) subjects in a separate cohort defined as MM-2 to evaluate tolerability, safety and preliminary efficacy of CC-122 formulated capsule alone or in combination with DEX on intermittent dosing schedule (5 of 7 days of the week) in Pomalidomide-naïve subjects. Preliminary efficacy data in Multiple Myeloma subjects, warrants further exploration of CC-122 in MM on intermittent schedules to assess if dose intensity and tolerability can be improved. Initially, patients will be treated with oral CC-122 for one month. During this time, various tests (involving blood and urine collections, ECGs, etc) will be performed. Those whose tumors stabilize or regress may continue receiving treatment for as long as they benefit from CC-122. Different dose levels of CC-122 will be tested in a dose-rising study design.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.

Men and women, 18 years or older, with histologically or cytologically-confirmed, advanced solid tumors, Non-Hodgkin Lymphona (NHL), Multiple Myloma (MM), or advanced unresectable solid tumors limited to the tumor types below.

Subjects who have progressed on (or not been able to tolerate) standard anticancer therapy or for whom no standard anticancer therapy exists. Must have disease that is objectively measurable

Measurable disease criteria:

Subjects with Glioblastoma multiforme (GBM) do not have to have objectively measurable disease at entry.
For MM, Diffuse large B-cell lymphoma (DLBCL): Subjects must have disease that is objectively measurable, measurable levels of myeloma paraprotein in serum (> 0.5 g/dL) or urine (> 0.2 g excreted in a 24-hour collection sample) for MM and measurable disease by Internatonal Working Group (IWG) for NHL (with at least one measurable lesion's longest diameter ≥ 2cm).
For Primary Central Nervous System (CNS) Lymphoma (PCNSL): Subjects must have disease that is objectively measurable by International Workshop to Standardize Baseline Evaluation and Response Criteria in Primary CNS Lymphoma, Cerebrospinal Fluid (CSF) cytology (in case of leptomeningeal only disease), or vitreal aspiration cytology and/or retinal photographs (in case of ocular lymphoma).

Tumor specific inclusion criteria:

DLBCL-2 cohort:

Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.
Histologically proven diffuse large B-cell non-Hodgkin's lymphoma
Must have progressed following or have been unable to tolerate at least one prior anthracycline or alkylating agent containing regimen (with or without anti-CD20).
Platelets ≥ 60 x 109/L.

For PCNSL cohort:

ECOG Performance Status of ≤ 2
Recurrent/refractory CNS non-Hodgkin's lymphoma involving CNS (Brain, Cerebrospinal fluid (CSF) or intraocular compartments)
Stable dose of glucocorticoids pre-therapy. If patients are receiving glucocorticoids, the dose should not increase during the 96 hours prior to initiation of therapy.
ECOG Performance Status of ≤ 2.

For glioblastoma multiforme (GBM-2) cohort:

ECOG Performance Status of ≤ 2
Primary GBM or gliosarcoma
ECOG Performance Status of ≤ 2.
Has received prior treatment including radiation and chemotherapy, with radiation completed > 12 weeks prior to Day 1 (or ≥ 4 weeks if the recurrence is outside of the prior radiation field).
Progression of disease after last therapy demonstrated by RANO criteria
No prior therapy with Avastin
No prior or scheduled Gliadel® wafer implant unless area of assessment and planned resection is outside the region previously implanted.
No prior interstitial brachytherapy or stereotactic radiosurgery unless area of assessment and planned resection is outside the region previously treated.
No enzyme-inducing anti-epileptic drugs (EIAED) such as carbamazepine, phenytoin, phenobarbital, or primidone within 14 days before Day 1.
Able to undergo repeated magnetic resonance imaging (magnetic resonance imaging (MRI), computed tomography (CT) scans).
Availability of adequate Formalin-fixed, paraffin embedded (FFPE) archival tumor material.
Platelets (plt) ≥ 100 x 109/L.

For Multiple Myeloma cohort

ECOG Performance Status of ≤ 1.
Have a documented diagnosis of multiple myeloma and have relapsed and refractory disease.

Measurable levels of myeloma paraprotein (M-protein) in serum (> 0.5 g/dL) or urine (> 0.2 g excreted in a 24-hour collection sample).

Patients must have received at least 2 prior therapies.
Patients must have relapsed after having achieved at least stable disease for at least one cycle of treatment to at least one prior regimen and then developed PD.
Patients must also have documented evidence of PD during or within 60 days (measured from the end of the last cycle) of completing treatment with the last anti-myeloma drug regimen used just prior to study entry (refractory disease).
Patients must have also undergone prior treatment with at least 2 cycles of lenalidomide and at least 2 cycles of a proteosome inhibitor (either in separate regimens or within the same regimen).
Must be Pomalidomide naïve.
Last dose of therapeutic glucocorticosteroids given greater than 14 days prior to start of study treatment.
Platelets (plt) ≥ 75 x 109/L in subjects in whom < 50% of bone marrow mononuclear cells are plasma cells or ≥ 30 x 109/L in subjects in whom ≥ 50% of bone marrow mononuclear cells are plasma cells.
At least 4 weeks from last dose of therapeutic glucocorticosteroids. Adrenal replacement doses of glucocorticosteroids (up to the equivalent of 10 mg daily prednisone) are allowed.
Biopsies (DLBLC, MM): Diagnostic archival FFPE (either in tumor blocks or sectioned/mounted specimens) may be submitted in lieu of a pre-study research biopsy if it has been obtained no more than 1 year prior to enrollment and only after discussion with the Celgene Medical Monitor

If not specified above as tumor specific parameter subjects must have the following laboratory and hematologic parameters as follows:

Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L without growth factor support for 7 days (14 days if received pegfilgrastim).
Hemoglobin (Hgb) ≥ 9 g/dL.
Platelets (Plt) ≥100 x 109/L.
Potassium within normal limits or correctable with supplements.
AST/SGOT and ALT/SGPT ≤ 3 x upper limit of normal (ULN) or ≤ 5.0 x ULN if liver tumor is present.
Serum creatinine ≤ ULN (with value applied to Cockcroft-Gault equation) or 24 hour clearance ≥ 50mL/min.
Negative serum pregnancy test in females of childbearing potential

Exclusion Criteria:

History of other carcinomas within the last 5 years except cured non-melanoma skin cancer, curatively treated in-situ cervical cancer, or localized prostate cancer with a current Prostate-specific antigen (PSA) of <1.0 mg/dL on 2 evaluations at least 3 months apart; the most recent evaluation must be no more than 4 weeks prior to Day 1 of the study drug, or other malignancies that were completely resected or treated Stage 1/2 lesions currently in complete remission.
Symptomatic central nervous system metastases (excluding Glioblastoma multiforrme (GBM) and Primary Central Nervous System Lymphoma (PCNSL). Subjects with brain metastases that have been previously treated and are stable for 6 weeks are allowed.
Known symptomatic acute or chronic pancreatitis.
Any peripheral neuropathy ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade 2.
Persistent diarrhea or malabsorption ≥ NCI CTCAE grade 2, despite medical management.

Impaired cardiac function or clinically significant cardiac diseases, including any of the following:

left ventricular ejection fraction (LVEF) < 45% as determined by multigated acquisition (MUGA) scan or echocardiography (ECHO).
Complete left bundle branch, or bifasicular block.
Congenital long QT syndrome.
Persistent or uncontrolled ventricular arrhythmias or atrial fibrillation.
QTcF > 460 msec on screening Electrocardiography (ECG) (mean of triplicate recordings).
Unstable angina pectoris or myocardial infarction ≤ 3 months prior to starting CC-122.

Troponin-T value > 0.4 ng/ml or BNP >300 pg/mL.

° Subjects with baseline troponin-T >Upper Limit of Normal (ULN) or B-type Natriuretic Peptide (BNP) >100 pg/mL are eligible but must have cardiologist evaluation prior to enrollment in the trial for baseline assessment and optimization of cardioprotective therapy.

Other clinically significant heart disease such as congestive heart failure requiring treatment or uncontrolled hypertension (blood pressure ≥ 160/95 mmHg).
Other concurrent severe and/or uncontrolled concomitant medical conditions (eg, active or uncontrolled infection or renal disease) that could cause unacceptable safety risks or compromise compliance with the protocol.
Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks, whichever is shorter, prior to starting study drug or who have not recovered from side effects of such therapy.
Major surgery ≤ 2 weeks prior to starting study drug or still recovering from post operative side effects.
Women who are pregnant or breast feeding. Adults of reproductive potential not employing two forms of birth control as per Pregnancy Prevention Risk Management Plan.
Known Human immunodeficiency virus (HIV) infection.
Known chronic hepatitis B or C virus (HBV/HCV) infection, unless comorbidity in subjects with Hepatocellular carcinoma (HCC).
Status post solid organ transplant.
Less than 100 days for subjects receiving autologous hematologic stem cell transplant (HSCT); or 6 months for subjects receiving allogenic HSCT or either transplant type, if otherwise not fully recovered from HSCT related toxicity.
For MM-2 cohort only: Hypersensitivity (eg, Rash Grade 3 or 4) to thalidomide, lenalidomide, or dexamethasone (MM-2b).
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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

271

Study ID:

NCT01421524

Recruitment Status:

Active, not recruiting

Sponsor:

Celgene

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There are 37 Locations for this study

See Locations Near You

City of Hope Cancer Center
Duarte California, 91010, United States
UCLA Neuro-Oncology Program
Los Angeles California, 90095, United States
University of California, San Francisco
San Francisco California, 9411, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Henry Ford Medical Center - New Center One
Detroit Michigan, 48202, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89169, United States
Rutgers Cancer Institute of New Jersey University
New Brunswick New Jersey, 08901, United States
Mount Sinai Hospital
New York New York, 10029, United States
Local Institution - 020
New York New York, 10065, United States
Weill Medical College of Cornell University
New York New York, 10065, United States
MUSC Rheumatology and Immunology Dept.
Charleston South Carolina, 29425, United States
Greenville Hospital System
Greenville South Carolina, 29605, United States
Sarah Cannon Research Institute Drug Development Unit
Nashville Tennessee, 37203, United States
Texas Oncology, PA - Dallas 75246
Dallas Texas, 75246, United States
South Texas Accelerated Research Therapeutics
San Antonio Texas, 78229, United States
Swedish Medical Center Cancer Institute Research
Seattle Washington, 98104, United States
Yakima Valley Memorial Hospital/ North Star Lodge
Yakima Washington, 98902, United States
Cliniques Universitaires Saint-Luc
Bruxelles , 1200, Belgium
UZ Leuven
Leuven , 3000, Belgium
CU CHU Clemenceau
Caen Cedex , 14033, France
Paoli CalmettesHematology
Marseille le Cedex , 13273, France
Centre Hospitalier Lyon Sud
Pierre Bénite , 69495, France
Institut universitaire du cancer de Toulouse (IUCT) - Oncopole
Toulouse CEDEX 9 , 31059, France
Institut Gustave Roussy
Villejuif Cedex , 94805, France
A.O.U. di Bologna Policlinico S.Orsola-Malpighi
Bologna , 40138, Italy
U.O.C. Ospedale Bellaria
Bologna , 40139, Italy
Istituto Nazionale Tumori
Milan , , Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
Napoli, Campania , 80131, Italy
Istituto Nazionale Tumori Regina Elena, Struttura Complessa Ematologia ed Unita di Cellule Staminali
Roma , 00144, Italy
Istituto Clinico Humanitas
Rozzano (MI) , 20089, Italy
Hospital Universitari Germans Trias i Pujol
Badalona (Barcelona) , 8916, Spain
Hospital del Mar
Barcelona , 08003, Spain
Local Institution - 101
Barcelona , 08035, Spain
Vall d´Hebron University Hospital
Barcelona , 08035, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid , 28040, Spain
Hospital 12 de Octubre
Madrid , 28041, Spain
Clinica Universidad de Navarra
Pamplona , 31008, Spain
Hospital Universitario de Salamanca
Salamanca , 37007, Spain
Hospital Virgen del Rocio
Sevilla , 41013, Spain
Hospital Universitario Clinico de Valencia
Valencia , 46010, Spain

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

271

Study ID:

NCT01421524

Recruitment Status:

Active, not recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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