Phase 4
Completed N=101
Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma
Source: ClinicalTrials.gov NCT01180049 ↗Enrolled (actual)
101
Serious AEs
69.0%
Results posted
May 2017
Primary outcomePrimary: Independently Assessed Progression-free Survival (PFS) — 4.3; 4.5 Months
Summary
This study will compare the effectiveness and safety of two different doses of temsirolimus (Torisel).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Independently Assessed Progression-free Survival (PFS) |
4.3; 4.5 | — |
| SECONDARY Overall Survival (OS) |
10.9; 11.2 | — |
| SECONDARY Independent Assessment - Objective Response Rate (ORR = CR + PR) |
27.7; 20.9 | — |
| SECONDARY Investigator's Assessment ORR (ORR = CR + PR) |
31.9; 18.6 | — |
| SECONDARY Investigator Assessed PFS |
4.7; 3.9 | — |
| SECONDARY Percentage of Participants With Treatment-Emergent Infection- Related Adverse Events (AEs) With Grade 2 or Higher as Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) |
17.0; 21.3; 7.5; 2.1; 5.7; 2.1 | — |
| SECONDARY Percentage of Participants With Treatment-Emergent Bleeding-Related AEs With Grade 2 or Higher as Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) |
13.2; 2.1; 1.9; 0 | — |
| SECONDARY Quantify the Potential Effect of TEMSR on AUC and Cmax |
1.00; 0.980; 0.828; 0.779 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01180049). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.