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

Pfizer

Status and phase: Completed; Phase 4

Conditions: Non-Hodgkin's Lymphoma

Treatments: Drug: temsirolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT01180049

2009-015498-11 (EudraCT Number)

3066K1-4438

B1771007 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

temsirolimus (Torisel) 175mg weekly x 3, then 75mg weekly

Active Comparator group

Treatment:

Drug: temsirolimus

Drug: temsirolimus

temsirolimus (Torisel) 75mg weekly

Active Comparator group

Treatment:

Drug: temsirolimus

Drug: temsirolimus