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A Randomized Phase 4 Study Comparing 2 Doses Of Intravenous Temsirolimus In Relapsed, Refractory Subjects With Mantle Cell Lymphoma (MCL)


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma (NHL)

Thank you

Trial Information

A Randomized Phase 4 Study Comparing 2 Doses Of Intravenous Temsirolimus In Relapsed, Refractory Subjects With Mantle Cell Lymphoma (MCL)


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Estimate independently assessed Progression Free Survival (PFS)

Outcome Time Frame:

every 6 weeks for first 2 assessments, then every 8 weeks in first year, every 12 weeks second year

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3066K1-4438

NCT ID:

NCT01180049

Start Date:

March 2011

Completion Date:

April 2015

Related Keywords:

  • Non-Hodgkin's Lymphoma (NHL)
  • Mantle Cell Lymphoma
  • non-Hodgkin lymphoma (NHL)
  • temsiolimus
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Mantle-Cell

Name

Location

West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
Mercy HospitalMiami, Florida  33133
Hematology Oncology Associates of IllinoisSkokie, Illinois  60077
North Shore Hematology OncologyLibertyville, Illinois  60048
Mercy Physicians of OklahomaTulsa, Oklahoma  74136
Veterans Affairs Puget Sound Health Care SystemSeattle, Washington  98108
Mercy Research InstituteMiami, Florida  33133
Floyd Memorial Cancer Center of IndianaNew Albany, Indiana  47150
Dr. Luis Villa Private OfficeMiami, Florida  33133
Dr. Jorge Antunez de Mayolo officeMiami, Florida  33133
Veterans Affairs New Jersey Healthcare System-Hematology/Oncology Section (111)East Orange, New Jersey  07018