A RANDOMIZED PHASE 4 STUDY COMPARING 2 INTRAVENOUS TEMSIROLIMUS (TEMSR) REGIMENS IN SUBJECTS WITH RELAPSED, REFRACTORY MANTLE CELL LYMPHOMA
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 101
- Locations
- 30
- Primary Endpoint
- Independently Assessed Progression-free Survival (PFS)
Study Overview
Brief Summary
This study will compare the effectiveness and safety of two different doses of temsirolimus (Torisel).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
temsirolimus (Torisel) 175mg weekly x 3, then 75mg weekly
Intervention: temsirolimus (Drug)
temsirolimus (Torisel) 75mg weekly
Intervention: temsirolimus (Drug)
Outcomes
Primary Outcomes
Independently Assessed Progression-free Survival (PFS)
Time Frame: From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)
PFS is defined as the time from randomization to first documentation of disease progression by the independent assessor or to death due to any cause, whichever occurred first. PFS = (earliest date of progression or death due to any cause- randomization date+1)/30.4. PFS assessment was done using EMA guidelines for sensitivity analysis censoring. Participants who were alive and progression-free at the time of analysis were censored on the date of last assessment; participants without adequate baseline assessment or without post-baseline assessments were censored on the randomization date; participants who died or progressed after 2 or more missed visits were censored on the date of last tumor assessment prior to the missing visit; and participants who started new anti-cancer therapy prior to death or progression were censored on the date of last tumor assessment prior to the start of anti-tumor treatment.
Secondary Outcomes
- Overall Survival (OS)(From randomization date until death due to any cause (average follow up done for 56.1 months))
- Independent Assessment - Objective Response Rate (ORR = CR + PR)(From randomization date until end of treatment (average follow up done for 15 months))
- Investigator's Assessment ORR (ORR = CR + PR)(From randomization date until end of treatment (average follow up done for 15 months))
- Investigator Assessed PFS(From randomization date to the date of first documentation of progression or death (average follow up done for 15 months))
- 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)(From screening up to a maximum of 57.1 months)
- 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)(From screening up to a maximum of 57.1 months)
- Quantify the Potential Effect of TEMSR on AUC and Cmax(From one week predose (Day -7, -4hr, -8hr, -48hr) upto 2 weeks post dose (4hr, 8hr, 48hr and Day 8))