Bendamustine and Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Non-Hodgkin's Lymphoma (NHL)
This study has been withdrawn prior to enrollment.
(insufficient enrollment)
Sponsor:
Charite University, Berlin, Germany
Collaborators:
Wyeth is now a wholly owned subsidiary of Pfizer
Mundipharma K.K.
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01170052
First received: July 14, 2010
Last updated: March 15, 2011
Last verified: June 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Mantle Cell Lymphoma |
Drug: Temsirolimus Drug: Bendamustine |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Bendamustine hydrochloride
Bendamustine
Sirolimus
Everolimus
Temsirolimus
U.S. FDA Resources
Further study details as provided by Charite University, Berlin, Germany:
Primary Outcome Measures:
- Phase I: Dose-finding [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Is the combination of temsirolimus alongside with bendamustine at the suggested dose feasible or are dose reductions necessary. Number of dose reductions or delays of therapy due to hematologic toxicities (CTCAE) or other adverse events according to protocoll.
- Phase II: Response Rate (Overall response rate, complete and partial response) [ Time Frame: 6 months ] [ Designated as safety issue: No ]What is the response rate of a therapy with temsirolimus and bendamustine.
Secondary Outcome Measures:
- Progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]This is defined as the period of time between the admission into the clinical trial and the progression of the lymphoma or death of any kind.
- Safety and Tolerability of Temsirolimus and Bendamustine Combination Therapy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Detection of overall toxicity, serious adverse events (SAE), suspected unexpected serious adverse reactions (SUSAR) during treatment with temsirolimus and bendamustine.
| Estimated Enrollment: | 20 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Temsirolimus
Temsirolimus 75mg i.v. day 1, 8, 15, 21 for a 28 day cycle with a maximum of 6 Cycles.
Other Name: Torisel®
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 18 years or older
- Mantle Cell Lymphoma according to REAL/WHO classification
- First or second relapse or alternatively progression during therapy. Previous use of Bendamustine is permitted, if the patient has reached at least partial remission and progression occured more than 6 months after therapy. Previous high dose chemotherapy with auto-SCT is permitted, if the patient has reached at least partial remission and progression occured more than 12 months after therapy.
- Patients must not be eligible for high dose chemotherapy with auto-SCT or allo-SCT.
- Adequate bone marrow function (hemoglobin > 9g/dl, platelet count >100/nL, absolute neutrophil count >1,5 /nL)
- WHO/ECOG Performance Status 0-2
- Measurable disease (two perpendicular diameters by either physical or radiological examination)
- Life expectancy ≥ 3 weeks
- Written informed consent
Exclusion Criteria:
- Prior treatment with any m-TOR Inhibitor
- Unstable or severe uncontrolled medical condition (e.g. severe congestive heart failure, myocardial infarction within the past 6 months, severe, uncontrolled arterial hypertension, renal insufficiency requiring hemodialysis, severe pulmonary disease, severe diabetes)
- Abnormal liver function: transaminases or total bilirubin > 2 x upper limit of normal (ULN)
- Abnormal renal function: serum creatinine > 2 x upper limit of normal
- Previous malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix.
- Concurrent treatment with strong inhibitors of CYP3A4 and/or inducers of CYP3A4
- Pregnant or breastfeeding women (negative pregnancy test not older than 7 days is required for women of fertile age). Men and women of child-bearing potential must agree to use adequate contraception (i.e. failure rate < 1% p.a. )
- Major surgery within 4 weeks before study entry; minor procedures (e.g. Implantation i.v. port catheter, Lymphnode biopsy) within 1 week before study entry
- Previous therapy with any investigational agents within 28 days before study entry
- Concomitant immunotherapy (e.g. Rituximab) or Chemotherapy other than Bendamustine. Use of systemic steroids should be documented and the Principal Investigator be informed.
- Central nervous system (CNS) lymphomatous involvement
- HIV positivity
- Current or chronic hepatitis B or hepatitis C infection
- Severe psychiatric illness or Individuals that are placed in an institution due to a magisterial or judiciary command.
- Inability to comply with study requirements
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170052
Locations
| Germany | |
| Dept. of Hematology and Oncology, Charité, Campus Virchow Klinikum Charité | |
| Berlin, Germany, 13353 | |
| Dept. of Hematology and Oncology, Charité, Campus Benjamin Franklin | |
| Berlin, Germany, 12203 | |
| Dept. of Hematology and Oncology, Charité, Campus Charité Mitte | |
| Berlin, Germany, 10117 | |
Sponsors and Collaborators
Charite University, Berlin, Germany
Wyeth is now a wholly owned subsidiary of Pfizer
Mundipharma K.K.
Investigators
| Principal Investigator: | Christian Scholz, PD Dr. | Charite University, Berlin, Germany |
More Information
No publications provided
| Responsible Party: | Principal Investigator: Christian Scholz, PD Dept. of Hematology, Charité Berlin, Germany, Charite University, Berlin, Germany |
| ClinicalTrials.gov Identifier: | NCT01170052 History of Changes |
| Other Study ID Numbers: | EudraCT-No.: 2009-014844-13 |
| Study First Received: | July 14, 2010 |
| Last Updated: | March 15, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Charite University, Berlin, Germany:
|
Relapsed Mantle Cell Lymphoma Refractory Mantle Cell Lymphoma Non-Hodgkins Lymphoma |
Temsirolimus Bendamustine Phase 1/2 |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bendamustine Nitrogen Mustard Compounds Sirolimus Everolimus |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antibiotics, Antineoplastic Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on October 17, 2012
