Lymphome T refractaire ou en rechute MedDRA version: 9.1 Level: LLT Classification code 10025632 Term: Malignant lymphoma
Conditions
Interventions
Trade Name: RIBOMUSTIN
Product Name: BENDAMUSTINE
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: BENDAMUSTINE
Other descriptive name: ribomustin,treanda, levact
Sponsors
GOELAMS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged more than 18 years • Must have measurable disease on cross sectional imaging by CT that is at least 2 cm in the longest diameter and measurable in two perpendicular dimensions • Refractory or relapsed peripheral T-cell NHL (PTCL). o Peripheral T-cell lymphoma unspecified. o Angioimmunoblastic lymphadenopathy disease. o Anaplastic T-cell lymphoma (ALK positive or negative). o NK/T cell lymphoma. o Subcutaneous panniculitis T-cell lymphoma. o Hepatosplenic T-cell lymphoma. o Enteropathy associated T-cell lymphoma. • Cutaneous T cell lymphoma (CTCL) in relapse or refractory to topical therapy. o Mycosis fungoides more or equal to IIB (appendices 9) • Life expectancy > 3 months. • ECOG score ? 2. • No major organ dysfunction unrelated to lymphoma. Creatinine clearance > 10 ml/min. • Platelet count > 100x109/L; ANC > 1x109/L. • Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed. • Patient should be able and willing to comply with study visits and procedures per protocol. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnant or breast feeding women. • ECOG score > 2. • Estimate survival time < 3 months. •Active infection or severe organ dysfunction or psychiatric condition that unable patients to receive chemotherapy. • Creatinine clearance < 10 ml/min or severe hepatic dysfunction not related to lymphoma. • Platelet count <100x109/L; ANC < 1x109/L and not secondary to lymphoma. • Patients who receive other concurrent investigational agent. • Previous chemotherapy/immunotherapy within 3 weeks before study entry or failure to recover from associated adverse events. • Investigational treatment within 28 days before inclusion ° Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). ° Patients who are seropositive because of hepatitis B virus vaccine are eligible. Prior history of malignancies, other than T cell lymphoma, unless the patient has been free of the disease for = 3 years. Exceptions include the following: - Basal cell carcinoma of the skin - Squamous cell carcinoma of the skin - Carcinoma in situ of the cervix - Carcinoma in situ of the breast - Incidental histological finding of prostate cancer (TNM stage of T1a or T1b) ° Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study • CNS lymphoma • T-cell Leukemia lymphoma associated with HTLV1. • Sezary syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): ;Main Objective: Determine the overall response rate (ORR) (CR+CRu+PR) in relapsed T cell lymphoma.;Secondary Objective: Evaluation of the tolerance and Safety of bensamustine in this subset of patients. Determination of the progression free survival (PFS), time to treatment failure (TTF), time to progression (TTP), overall survival (OS) and the duration of response. | — |
Countries
France
Outcome results
None listed