Treatment ot mantle cell lymphoma patients in first or second relapse or refractory disease. Patients should not be eligible for high dose chemotherapy with autologous or allogenous stem cell transplantation.
Conditions
Interventions
Trade Name: Torisel
Product Name: Temsirolimus
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TEMSIROLIMUS
CAS Number: 162635-04-3
Current Sponsor code: CCI-779
Other
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. Histologically proven mantle cell lymphoma 3. First or second relapse or progression during treatment. A prior treatment with bendamustine ist feasible, if the patient achieved at least a partial response and progression free survival lasted at least six months. A prior high dose chemotherapy with autologous stem cell transplantation is feasible, if the patient achieved at least a partial response and progression free survival lasted at least twelve months. 4. Patients are not eligible for high dose chemotherapy and autologous or allogenous stem cell transplantation. 5. Sufficient bone marrow reserve (hemoglobuline > 9 g/dL, thrombocytes > 100/nL, neutrophile granulocytes > 1.5/nL) 6. WHO/ECOG performance status 0 – 2 7. Measurable disease (two perpendicular diameters in radiologic evaluation) 8. Life expectancy of at least three months 9. Written consent 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: 1. Prior treatment with an mTOR inhibitor 2. Severe concomitant disease (e.g. severe cardiac insufficiency, myocardial infarction within the last six months prior to inclusion into the clinical trial, uncontrolled arterial hypertension, renal failure requiring dialysis, severe lung disease, severe liver disease, severe diabetes mellitus) 3. Disturbed liver function: transaminases or total bilirubine > 2 x upper limit of normal 4. Disturbed kidney function: serum-creatinine > 2 x upper limit of normal 5. Coexistant or prior malignant tumor within the last three years with the exception of an adequately treated basal cell carcinoma or a cervical carcinoma in situ. 6. Concomitant treatment with strong inducers or inhibitors of CYP3A4 7. Women, pregnant or breast feeding, may not be included into the trial. The same applies for fertile patients, women and men alike, that are not willing to perform an efficient contraception. An effective contraception has a failure rate below 1% per year (e.g. sexual abstinence or vasectomy). Fertile women have to have a negative pregnancy test that is not older than seven days. 8. Bigger surgical procedures within the last four weeks prior to inclusion. Smaller surgical procedures (e.g. implantation of an i.v. portal catheter) within one week prior to inclusion. 9. Prior treatment in a clinical trial within the last four weeks prior to inclusion into the clinical trial. 10. Concomitant immunotherapy (e.g. Rituximab) or chemotherapy except bendamustine. The usage of systemic steroids should be documented and reported to the leading clinical trial center. 11. CNS-manifestation 12. HIV-positivity 13. Active or inactive hepatitis B or hepatitis C infection 14. Severe psychiatric disease 15. Individuals that are placed into an institution due to magisterial or judicical order 16. Incapacity to follow the protocol requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Dose finding (phase I of the clinical trial): is the combination of temsirolimus with bendamustine at the suggested doses feasible or are dose reductions necessary. - Resonse rate (overall response rate (ORR), complete remissions (CR), partial remissions (PR) (phase II part of the clinical trial): what is the response rate of a treatment with temsirolimus alongside with bendamustine.;Secondary Objective: - Duration of progression free survival (PFS) - Safety and tolerability: Assessment of serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR) during treatment with temsirolimus and bendamustine.;Primary end point(s): - Dose finding (phase I of the clinical trial): is the combination of temsirolimus alongside with bendamustine at the suggested dose feasible or are dose reductions necessary. Temsirolimus is administered at the concentration that proved to be efficient in a recent phase three trial. Temsirolimus has been licensed for treatment of relapsed mantle cell lymphoma at this dose. - Response rate (overall response rate (ORR), complete remissions (CR), partial remissions (PR) (phase II of the clinical trial: what is the response rate of a therapy with temsirolimus and bendmustine. | — |
Countries
Germany
Outcome results
None listed