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This study has been withdrawn prior to enrollment.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:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 14, 2010

Last Updated Date

March 15, 2011

Start Date ^ICMJE

May 2010

Estimated Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01170052 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Bendamustine and Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Non-Hodgkin's Lymphoma (NHL)

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Mantle Cell Lymphoma

Intervention ^ICMJE

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.

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2014

Estimated Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01170052

Other Study ID Numbers ^ICMJE

EudraCT-No.: 2009-014844-13

Has Data Monitoring Committee

Responsible Party

Principal Investigator: Christian Scholz, PD Dept. of Hematology, Charité Berlin, Germany, Charite University, Berlin, Germany

Study Sponsor ^ICMJE

Charite University, Berlin, Germany

Collaborators ^ICMJE

Wyeth is now a wholly owned subsidiary of Pfizer
Mundipharma K.K.

Investigators ^ICMJE

Principal Investigator:

Christian Scholz, PD Dr.

Charite University, Berlin, Germany

Information Provided By

Charite University, Berlin, Germany

Verification Date

June 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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