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Study Evaluating Temsirolimus (CCI-779) in Mantle Cell Lymphoma (MCL)
This study is ongoing, but not recruiting participants.
First Received: June 30, 2005   Last Updated: December 19, 2007   History of Changes
Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00117598
  Purpose

This is an open-label, randomized trial in relapsed refractory subjects with mantle cell lymphoma (MCL).


Condition Intervention Phase
Lymphoma
Drug: Temsirolimus (CCI-779)
Phase III

MedlinePlus related topics: Lymphoma
Drug Information available for: CCI 779
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: An Open-Label, Randomized, Phase 3 Trial of Intravenous Temsirolimus (CCI-779) at Two Dose Levels Compared to Investigator's Choice Therapy in Relapsed, Refractory Subjects With Mantle Cell Lymphoma (MCL)

Further study details as provided by Wyeth:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability, Objective Response Rate, Overall Survival [ Time Frame: Duration of trial ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 177
Study Start Date: April 2005
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental Drug: Temsirolimus (CCI-779)
1 (175/25 mg TEMSR), 2 (175/25 mg TEMSR), 3 (Investigator's Choice)
B: Experimental Drug: Temsirolimus (CCI-779)
1 (175/25 mg TEMSR), 2 (175/25 mg TEMSR), 3 (Investigator's Choice)
C Drug: Temsirolimus (CCI-779)
1 (175/25 mg TEMSR), 2 (175/25 mg TEMSR), 3 (Investigator's Choice)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mantle cell lymphoma (MCL) confirmed with histology, immunophenotype, and cyclin D1 analysis
  • Received 2 to 7 prior therapies which may include hematopoietic stem cell transplant (i.e. induction + consolidation + maintenance)
  • Prior treatment with an alkylating agent and an anthracycline, rituximab, individually or in combination, and status that is at least one of the following:

    • Primary disease refractory to at least 2 regimens;
    • Refractory to at least 1 regimen after first relapse;
    • Refractory or untreated after second or greater relapse;
    • Refractory to first line and relapsed after second line. Chemotherapy combinations may include, but are not limited to: CHOP, R-CHOP, FCM, R-FCM, ICE, DHAP, and hyper-CVAD.

Exclusion Criteria:

  • Subjects who are less than or equal to six month from allogeneic hematopoietic stem cell transplant and who are on immunosuppressive therapy or have evidence of graft versus host disease
  • Prior investigational therapy within 3 weeks of first dose. Investigational therapy is defined as treatment that is not approved for any indication.
  • Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth. (Treated CNS metastases must be stable for > 2 weeks prior to Day 1.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117598

  Show 62 Study Locations
Sponsors and Collaborators
Wyeth
Investigators
Study Director: Medical Monitor Wyeth
  More Information

No publications provided

Responsible Party: Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers: 3066K1-305
Study First Received: June 30, 2005
Last Updated: December 19, 2007
ClinicalTrials.gov Identifier: NCT00117598     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth:
Lymphoma

Study placed in the following topic categories:
Lymphatic Diseases
Immunoproliferative Disorders
Lymphoma, Mantle-Cell
Mantle Cell Lymphoma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:
Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Lymphoma, Mantle-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009