PATIENTS WITH RELAPSED OR REFRACTORY MANTLE-CELL LYMPHOMA NON-ELIGIBLE FOR AUTO OR ALLO STEM CELL TRANSPLANTATION MedDRA version: 17.0 Level: PT Classification code 10026803 Term: Mantle cell lymphoma stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: MabThera subcutaneo
Product Name: Rituximab
Product Code: Rituximab
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Curre
Sponsors
Grupo Español de Linfoma y Trasplante Autólogo de Médula ósea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Basal diagnosis of mantle-cell lymphoma in relapse or refractory. Achievement of a CR or PR after salvage therapy with R-GemOxD (6 to 8 cycles) as previously described. Age > 18 years. One or maximum two prior chemotherapy or immunochemotherapy lines. Patients should not be considered candidates for high-dose chemotherapy and autologous stem-cell transplantation. No clinical evidence of CNS involvement Signed informed consent Serum creatinine less than 2 and/or bilirrubin less than 2.5 UNL. 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: Prior organ transplantation. HIV positive. Patients with Active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection (must be ruled out during Screening) [Note: Patients with hepatitis B or C positive serology testing (i.e. positive hepatitis B virus antibodies serology or positive hepatitis C virus antibodies serology) but with undetectable viral load (i.e. negative PCR for HBV R NA or HCV RNA) may be included] Any serious active disease or co-morbid medical condition (according to the investigator?s decision) Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 cervix carcinoma. Less than 50% of tumor response. Platelet counts less than 50 x 109/L. Neutrophil counts less than 1.0 x 109/L. Inability to provide informed consent and comply with protocol requirements. Life expectancy of less than 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Time to relapse/progression (TTP) after achieving a complete or partial response with the (R-GemOxD)-induction therapy;Secondary Objective: Quality of response obtained after subcutaneous Rituximab maintenance. Progression-Free Survival (PFS) Overall Survival (OS) Time to Next Therapy (TTNT) Value of MRD in the disease outcome Toxicity;Primary end point(s): Time to relapse/progression (TTP) after achieving a complete or partial response with the (R-GemOxD)-induction therapy;Timepoint(s) of evaluation of this end point: Time to relapse/progression (TTP) after achieving a complete or partial response with the (R-GemOxD)-induction therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Quality of response obtained after subcutaneous Rituximab maintenance. Progression-Free Survival (PFS) Overall Survival (OS) Time to Next Therapy (TTNT) Value of MRD in the disease outcome Toxicity During all the trial;Timepoint(s) of evaluation of this end point: Quality of response obtained after subcutaneous Rituximab maintenance. Progression-Free Survival (PFS) Overall Survival (OS) Time to Next Therapy (TTNT) Value of MRD in the disease outcome Toxicity During all the trial | — |
Countries
Spain
Contacts
Public ContactÁngel Pérez
Dynamic Science
Outcome results
None listed