Study to determine the recommended dose, the safety and the efficacy of lenalidomide administered in association with obinutuzumab (GA101) for the treatment of relapsed/refractory B-cell Lymphoma.
- Conditions
- Phase IB: CD20 positive Follicular Lymphoma, WHO grade 1, 2 or 3a relapsed/refractory after =1 prior R-containing regimen Phase II: CD20 positive follicular and agressive B-cell lymphoma (Diffuse Large B-Cell Lymphoma and Mantle Cell Lymphoma) relapsed/refractory after =1 prior R-containing regimenMedDRA version: 15.0Level: PTClassification code 10016906Term: Follicle centre lymphoma, follicular grade I, II, III refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.0Level: PTClassification code 10012822Term: Diffuse large B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.0Level: PTClassification code 10026801Term: Mantle cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2011-005150-62-FR
- Lead Sponsor
- GELARC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Phase IB only: Histologically documented CD20-positive follicular lymphoma (WHO grade 1, 2, or 3a) patients
Phase II only: patients with either histologically documented CD20-positive Diffuse large-cell lymphoma or Mantle cell lymphoma (cohort 1) or follicular lymphoma, WHO grade 1, 2 or 3a (cohort 2)
Phase IB and II:
- Relapsed/refractory NHL after =1 prior R-containing regimen with no curative option
- Aged 18 years or more
- ECOG performance status 0, 1 or 2
- At least one bi-dimensionally measurable nodal or tumor lesion defined by CT scan as: greatest transverse diameter > 1.5 cm and a short axis =
10mm
- Signed inform consent
- Life expectancy of = 3 months
- All subjects must be able to understand and fulfill the lenalidomide Pregnancy Prevention Plan requirements
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 148
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
- Previous treatment with obinutuzumab or lenalidomide
- Known CD20 negative status at relapse/progression. Biopsy at relapse/progression is recommended but not mandatory
- Central nervous system or meningeal involvement by lymphoma
- Contraindication to any drug contained in the study treatment regimen
- Known HIV or HTLV-1 infection, positive serology to HB surface antigen [HBsAg] or total HB core antibody [anti-HB-c]) and Hepatitis C (Hepatitis C virus [HCV] antibody)
- Any serious active disease or co-morbid medical condition (such as New York Heart Association Class III or IV cardiac disease, severe arrhythmia, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm or other according to investigator’s decision)
- Any of the following laboratory abnormalities.
o Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L).
o Platelet count < 100,000/mm3 (100 x 109/L) unless due to lymphoma for phase II part.
o Serum SGOT/AST or SGPT/ALT 3.0 x upper limit of normal (ULN) unless disease involvement.
o Serum total bilirubin > 2.0 mg/dL (34 µmol/L), except if disease related or in case of Gilbert syndrome.
- Calculated creatinine clearance (Cockcroft-Gault formula or MDRD) of < 50 mL /min. For phase II part of the study, patients with calculated
creatinine clearance between 30 and 50ml/min can be included and lenalidomide dose will be adjusted as follows (10mg once daily).
- Prior history of malignancies other than lymphoma unless the subject has been free of the disease for = 5 years
- Any serious medical condition, laboratory abnormality (other than mentioned above), or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or lactating females.
- Prior = Grade 3 allergic reaction/hypersensitivity to thalidomide.
- Prior = Grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
- Subjects with = Grade 2 neuropathy.
- Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug therapy
- Patients taking corticosteroids during 4 weeks before inclusion, unless administered at a dose equivalent to = 10 mg/day prednisone (over these 4 weeks).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method