Phase I/II clinical trial with Bendamustine and Temsirolimus in patients with relapsed or refractory mantle cell lymphoma that are not eligible for high dose chemotherapy and stem cell transplantation. - Bendamustine and Temsirolimus in relapsed or refractory mantle cell lymphoma

Phase 1

• Conditions: 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.

• Registration Number: EUCTR2009-014844-13-DE
• Lead Sponsor: Charité Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-12-29
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified