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
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma (NHL)
Both
Non-Hodgkin's Lymphoma (NHL)
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 Center | Kalamazoo, Michigan 49007-3731 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
| Mercy Hospital | Miami, Florida 33133 |
| Hematology Oncology Associates of Illinois | Skokie, Illinois 60077 |
| North Shore Hematology Oncology | Libertyville, Illinois 60048 |
| Mercy Physicians of Oklahoma | Tulsa, Oklahoma 74136 |
| Veterans Affairs Puget Sound Health Care System | Seattle, Washington 98108 |
| Mercy Research Institute | Miami, Florida 33133 |
| Floyd Memorial Cancer Center of Indiana | New Albany, Indiana 47150 |
| Dr. Luis Villa Private Office | Miami, Florida 33133 |
| Dr. Jorge Antunez de Mayolo office | Miami, Florida 33133 |
| Veterans Affairs New Jersey Healthcare System-Hematology/Oncology Section (111) | East Orange, New Jersey 07018 |
