Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01180049
First received: August 9, 2010
Last updated: October 2, 2014
Last verified: October 2014
  Purpose

This study will compare the effectiveness and safety of two different doses of temsirolimus (Torisel).


Condition Intervention Phase
Non-Hodgkin's Lymphoma (NHL)
Drug: temsirolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase 4 Study Comparing 2 Intravenous Temsirolimus (Temsr) Regimens In Subjects With Relapsed, Refractory Mantle Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Estimate independently assessed Progression Free Survival (PFS) [ Time Frame: every 6 weeks for first 2 assessments, then every 8 weeks in first year, every 12 weeks second year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Estimate Overall survival [ Time Frame: every 3 months from last dose of study drug ] [ Designated as safety issue: No ]
  • Estimate objective response rate [ Time Frame: every 6 weeks for first 2 assessments, then every 8 weeks in first year, every 12 weeks second year ] [ Designated as safety issue: No ]
  • Estimate PFS per investigator [ Time Frame: every 6 weeks for first 2 assessments, then every 8 weeks in first year, every 12 weeks second year ] [ Designated as safety issue: No ]
  • Assess safety, including infection and bleeding [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
  • Quantify potential of temsirolimus to alter disposition of desipramine, a substrate of CYP2D6 metabolism [ Time Frame: first 2 weeks of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2011
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: temsirolimus (Torisel) 175mg weekly x 3, then 75mg weekly Drug: temsirolimus
175mg IV once a week for first 3 weeks, followed by 75mg IV once a week until disease progression, provided that patient is tolerating treatment and getting clinical benefit
Other Name: Torisel
Active Comparator: temsirolimus (Torisel) 75mg weekly Drug: temsirolimus
75mg IV once a week until until disease progression, provided that patient is tolerating treatment and getting clinical benefit
Other Name: Torisel

  Eligibility

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

Inclusion Criteria:

  • Have confirmed mantle cell lymphoma diagnosis.
  • Have measurable disease.
  • Have received at least 2 prior treatment, which may include stem cell transplant.
  • Have adequate organ and bone marrow function.
  • There are other criteria--please discuss with your doctor.

Exclusion Criteria:

  • Had any prior treatment with temsirolimus or mTOR inhibitor.
  • Had allogeneic stem cell transplant within last 6 months and on immunosuppressive therapy.
  • Has active or untreated brain or central nervous system metastases.
  • There are other criteria--please discuss with your doctor.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01180049

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 43 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01180049     History of Changes
Other Study ID Numbers: 3066K1-4438, B1771007, 2009-015498-11
Study First Received: August 9, 2010
Last Updated: October 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Mantle Cell Lymphoma
non-Hodgkin lymphoma (NHL)
temsirolimus

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014