Master protocol for mantle cell lymphoma A multicenter stratified phase II trial testing Everolimus (RAD001) for the treatment of patients with newly diagnosed and relapsed or therapy resistant mantle cell lymphoma - ND
- Conditions
- mantle cell lymphoma patientsMedDRA version: 9.1Level: LLTClassification code 10061275Term: Mantle cell lymphomaMedDRA version: 9.1Level: LLTClassification code 10026801Term: Mantle cell lymphoma refractoryMedDRA version: 9.1Level: LLTClassification code 10026800Term: Mantle cell lymphoma recurrent
- Registration Number
- EUCTR2007-001108-19-IT
- Lead Sponsor
- SAKK - GRUPPO SVIZZERO DI RICERCA CLINICA SUL CANCRO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 58
.histologically/cytolocigically confirmed newly diagnosed and relapsed or chemotherapy/immunotherapy resistant mantle cell lymphoma (not more than 3 lines of prior systemic treatment) · Patients must have at least one measurable lesion ≥15 mm in its greatest transverse diameter with CT scan (MRI is allowed only if CT scan cannot be performed). · Age ≥ 18 years · WHO Performance status ≤ 2 · Adequate renal function · Adequate liver function · Adequate hematological values
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
.Patients with concomitant or any hematological malignancies in the past · Presence or history of CNS disease · Patients suitable for intensive treatment e.g. HyperCVAD · Cardiovascular disease · Previous organ transplantation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of the efficacy and tolerability of Everolimus in patients with newly diagnosed, stratum 1, and in patients with relapsed or with therapy resistant MCL, stratum 2.;Secondary Objective: ;Primary end point(s): Objective response
- Secondary Outcome Measures
Name Time Method