Refractory Diffuse large B-cell lymphoma. MedDRA version: 17.0 Level: PT Classification code 10012822 Term: Diffuse large B-cell lymphoma refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Revlimid 5 mg
Product Name: Lenalidomide
Product Code: NA
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Concentration unit: mg milligram(s)
C
Sponsors
Grupo Español para el Tratamiento y Estudio de los Linfomas (GOTEL)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients over 18 years old. 2. Patients with diffuse large cell lymphoma (DLBCL) diagnosed by biopsy, including immunohistochemical positivity for CD20 study. 3. Patients with relapsed or refractory DLBCL (DLBCL r / r) after receiving at least a first line of treatment that included chemotherapy and anti-CD20 monoclonal antibodies. Biopsy recommended but not mandatory. 4. Patients who are not candidates for autologous hematopoietic cell transplantation according to the investigator´s criteria. 5. ECOG Performance Status ? 2. 6. Life expectancy over 3 months. 7. All patientsmust accept common contraception methods in clinical trials with lenalidomide. 8. Women of childbearing potential must have a negative pregnancy test result at screening. 9. Signed informed consent. 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 77 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients who may be susceptible of autologous bone marrow transplant during the evolution of the disease according to investigator´s criteria. 2. Patients with inadequate renal, hepatic or haematological function, and / or showing any of the following laboratory parameters (It is not allowed the use of colony stimulating factors and other similar measures for the inclusion of patients): - ANC 5 normal level - Total bilirubin > 2 mg/dl o conjugated bilirubin > 0.8mg/dl, except if hemolytic anemia. - Creatinine clearance 2 months before starting experimental treatment despite adequate anti-infective treatment. 6. Pregnant or lactating women. 7. Rejection of contraceptive methods according to the protocol. 8. Patients who had received any experimental therapy within 28 days prior to inclusion in the clinical trial. 9. Involvement of central nervous system confirmed by cerebrospinal fluid cytology or imaging test. 10. Previous history of malignant disease unless the patient has been free of disease ? 3 years. The following neoplasia are excluded: - Basal cell carcinoma of skin - Squamous cell carcinoma of skin - Carcinoma in situ of the cervix - Carcinoma in situ of breast - Incidentally diagnosed prostate carcinoma (T1a or T1b) 11. Seropositivity for HIV, Hepatitis B or Hepatitis C 12. Uncontrolled intercurrent illness, such as: - Active infection requiring parenteral antibiotics - Uncontrolled diabetes mellitus - Chronic heart failure (class III or IV NYHA) - Unstable angina or angioplasty, stent or heart attack in the last 6 months - Thromboembolic disease grade 3-4 in the past 6 months - Prior neuropathy grade ? 2 13. Patients who have received any of the following treatments in the specified period prior day 1: - Any chemotherapy in the previous 2 weeks - Nitrosoureas in the previous 6 weeks - Monoclonal antibodies in previous 8 weeks - External radiotherapy in the previous 3 weeks - Radioimmunoconjugates in the previous 12 weeks
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Until disease progression, unacceptable toxicity or complete response confirmed by PET after 2 years of treatment.;Secondary end point(s): - Overall survival: from recruitment or the start of treatment to the date of patient´s death or last date known as the patient was alive. - Progression-free survival: from recruitment or the start of treatment to recurrence of disease. - Safety: collection and assessment of all adverse events occurring since the signing of informed consent until the last patient visit (SPM last visit at 36 months since the last dose of Lenalidomide). - Biomarker analysis in tumor tissue, associated with the immune response. - Genomic Study of oncogenic mutations. - Serum flow cytometric immunophenotypic studies. - Relationship between data taken from translational research and clinical data, paying special attention to the subgroup of long-responders (sustained response over 2 years after receiving the treatment). | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the response rate with the combination of lenalidomide and chemotherapy type R-GDP (Rituximab, Gemcitabine, Dexamethasone and Cisplatin) in patients with relapsed or refractory diffuse large B-cell lymphoma not candidates for high-dose chemotherapy nor transplantation of cells hematopoietic progenitors.;Secondary Objective: -Overall survival -Progression free survival -Safety -Biomarker analysis in tumor tissue, associated with the immune response. -Genomic analysis of oncogenic mutations -Serum immunophenotypic study using flow cytometry -Correlate data taken from translational research to clinical data, paying special attention to the subgroup of long-responders;Primary end point(s): Overall Response Rate obtained after the period or phase induction obtained with the combination of lenalidomide and immunochemotherapy (R2-GDP) in patients with DLBCL R / R. The Overall Response Rate is defined as the addition of the rate of complete response plus partial response rate obtained, according to Cheson criteria 2007.;Timepoint(s) of evaluation of this end point: At the end of the induction phase. 180 days. | — |
Countries
Spain
Contacts
Public ContactClara M. Rosso Fernández
Clinical Research Unit & Clinical Trials
Outcome results
None listed