Trials / Withdrawn
WithdrawnNCT01170052
Bendamustine and Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Non-Hodgkin's Lymphoma (NHL)
Phase I/II Study With Bendamustine and Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Non-hodgkin's Lymphoma (NHL) Not Eligible for High Dose Chemotherapy and Autologous/Allogeneic Stem Cell Transplantation
- Status
- Withdrawn
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Charite University, Berlin, Germany · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the safety, tolerability and activity of the combination of bendamustine and rituximab in patients with relapsed/refractory mantle cell lymphoma who are not eligible for high dose chemotherapy and autologous/allogeneic stem cell transplantation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Temsirolimus | Temsirolimus 75mg i.v. day 1, 8, 15, 21 for a 28 day cycle with a maximum of 6 Cycles. |
| DRUG | Bendamustine | Bendamustin 90mg/m2 i.v. day 2 and 3 for a 28 day cycle with a maximum of 6 Cycles. |
| DRUG | Temsirolimus | Consolidation Therapy for Patients reached CR or PR with Temsirolimus 75mg weekly until progression. |
Timeline
- Start date
- 2010-05-01
- Primary completion
- 2012-04-01
- Completion
- 2014-04-01
- First posted
- 2010-07-27
- Last updated
- 2011-03-16
Locations
3 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT01170052. Inclusion in this directory is not an endorsement.