Bendamustine in patients with refractory or relapsed T-cell lymphoma. A phase II multicenter studyBENTLY” - BENTLY
- Conditions
- ymphome T refractaire ou en rechuteMedDRA version: 9.1Level: LLTClassification code 10025632Term: Malignant lymphoma
- Registration Number
- EUCTR2009-010017-72-FR
- Lead Sponsor
- GOELAMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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).
oPeripheral T-cell lymphoma unspecified.
oAngioimmunoblastic lymphadenopathy disease.
oAnaplastic T-cell lymphoma (ALK positive or negative).
oNK/T cell lymphoma.
oSubcutaneous panniculitis T-cell lymphoma.
oHepatosplenic T-cell lymphoma.
oEnteropathy associated T-cell lymphoma.
•Cutaneous T cell lymphoma (CTCL) in relapse or refractory to topical therapy.
oMycosis 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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>Determination of the progression free survival (PFS), time to treatment failure (TTF), time to progression (TTP), overall survival (OS) and the duration of response.<br>
- Secondary Outcome Measures
Name Time Method