Patients with Relapsed and Primary Refractory Lymphoma MedDRA version: 9.1 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell
Conditions
Interventions
Trade Name: GEMZAR*INFUS 1FL 1G POLV
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Gemcitabine
CAS Number: 122111-03-9
Concentration unit: mg milligram(s)
Conc
Sponsors
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE "G. PASCALE"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 4.1.1 Patients must have histologically confirmed diagnosis of lymphoma of the following subtypes according to REAL/WHO , Non-Hodgkin's lymphomas ? Diffuse Large B Cell Lymphoma (DLBCL) and variants ? Anaplastic Large Cell Lymphoma (ALCL) B/null ? Mantle Cell Lymphoma (MCL) ? Follicular Cell Lymphoma (FCL) Grade 3 ? Histologic Transformation of previous indolent lymphomas Hodgkin's disease ? Classic Hodgkin's Lymphoma including lymphocyte rich category 4.1.2 Patient must be relapsing to or primary progressive while on 1st-line induction anthracycline-containing chemotherapy with and without immunotherapy (Rituximab) and/or radiotherapy 4.1.3 Patients must have measurable disease, defined according criteria detailed in Section 12. 4.1.4 Age >18 years 4.1.5 Life expectancy of greater than 3 months. 4.1.6 ECOG performance status 1,500/mL - Platelets >100,000/mL - Total bilirubin within normal institutional limits - AST (SGOT)/ALT (SGPT) 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal, as calculated by using the Cockcroft-Gault formula: (140 ? Age) x Weight (kg) x [1-(0.15 x Sex)] 0.814 x Serum Creatinine (mg/dL) Sex: Male=0; Female=1 4.1.8 Ability to understand and the willingness to sign a written informed consent document including consent for ASCT in patients aged =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 4.2.1 Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. 4.2.2 Patients may not be receiving any other investigational agents. 4.2.3 Patients with known lymphoma brain localization should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse events. 4.2.4 History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study. 4.2.5 Uncontrolled intercurrent illness including, but not limited to, ongoing active infection (including hepatitis B), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrollable metabolic disease, or psychiatric illness/social situations that would limit compliance with study requirements. 4.2.6 Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects of agents employed. 4.2.7 Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients are excluded. 4.2.8 More than one month between staging procedures and the start of the treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The goal of this phase II study is to evaluate the clinical activity and toxicity of a short-course (bi-weekly), dose-intensive, cytoreductive/mobilizing salvage regime which combines Oxaliplatin and Gemcitabine, with Ifosfamide and Rituximab (R-GIFOX), in patients with relapsed and refractory CD20+ NHL of aggressive histology and cHD.;Secondary Objective: o Overall Final Response Rate (fORR: PR/CR/CRu ) at re-evaluation after completing the whole treatment program (i.e. R-GIFOX x3 → HDT/ASCT or R-GIFOX x 6), Failure Free Survival (FFS) and Relapse Free Survival (RFS). o Collection of at least 2.0 x 106 peripheral CD34+ cells/kg following the 3rd R- GIFOX course in patients aged <= 65 years. o Correlation of clinical response with the actual delivered dose intensity (ADI) of Oxaliplatin and Gemcitabine. o Correlation of clinical response to R-GIFOX with specific biologic features of lymphoma cells (i.e. presence of specific chromosomal translocations ? t(14;18), t(11;14), t(11;18), t(1; 14) and absolute levels of BCL-2 RNA and/or protein).;Primary end point(s): o Overall Early Response Rate (eORR: PR/CR/CRu ) of at least 50% (i.e. at re evaluation after the 3rd R-GIFOX course). This endpoint is considered for sample size calculation. o Hematologic and extrahematologic toxicity (according to CTCAE v3.0). | — |
Countries
Italy
Outcome results
None listed