Clinical trial NCT01180049: Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma
Official title: A RANDOMIZED PHASE 4 STUDY COMPARING 2 INTRAVENOUS TEMSIROLIMUS (TEMSR) REGIMENS IN SUBJECTS WITH RELAPSED, REFRACTORY MANTLE CELL LYMPHOMA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-Hodgkin's Lymphoma
Keywords: Mantle Cell Lymphoma
Non-Hodgkin's Lymphoma
temsirolimus
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-08-11
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Independently Assessed Progression-free Survival (PFS)
timeFrame: From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From randomization date until death due to any cause (average follow up done for 56.1 months)
measure: Independent Assessment - Objective Response Rate (ORR = CR + PR)
timeFrame: From randomization date until end of treatment (average follow up done for 15 months)
measure: Investigator's Assessment ORR (ORR = CR + PR)
timeFrame: From randomization date until end of treatment (average follow up done for 15 months)
measure: Investigator Assessed PFS
timeFrame: From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)
measure: 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)
timeFrame: From screening up to a maximum of 57.1 months
measure: 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)
timeFrame: From screening up to a maximum of 57.1 months
measure: Quantify the Potential Effect of TEMSR on AUC and Cmax
timeFrame: From one week predose (Day -7, -4hr, -8hr, -48hr) upto 2 weeks post dose (4hr, 8hr, 48hr and Day 8)
Other outcomes:
Locations:
city: Miami
country: United States
facility: Mercy Research Institute
state: Florida
city: East Orange
country: United States
facility: Veterans Affairs New Jersey Healthcare System-Hematology/Oncology Section (111)
state: New Jersey
city: Oklahoma City
country: United States
facility: Mercy Clinic Oklahoma Communities dba Mercy Clinic Oncology/Hematology-McAuley
state: Oklahoma
city: Oklahoma City
country: United States
facility: Mercy Hospital Oklahoma City-Oncology Infusion
state: Oklahoma
city: Seattle
country: United States
facility: Amy Shen, RPh
state: Washington
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
city: Kogarah
country: Australia
facility: St George Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
state: Czech Republic
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Vandoeuvre les Nancy
country: France
facility: CHU de Nancy
city: Aachen
country: Germany
facility: Klinik fuer Onkologie und Haematologie, Medizinische Klinik IV
city: Mainz
country: Germany
facility: Klinikum Johannes-Gutenberg -Universitaet, III. Medizinische Klinik und Poliklinik
city: Catania
country: Italy
facility: Presidio Ferrarotto - A.O.U. - PoliclinicoVittorio Emanuele
city: Modena
country: Italy
facility: Dipartimento di Medicina Diagnostica, Clinica e di Sanità Pubblica
city: Torino
country: Italy
facility: Struttura Complessa di Ematologia, Dipartimento di Oncologia ed Ematologia-
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne S.C.
city: Bucuresti
country: Romania
facility: Institutul Clinic Fundeni Bucuresti, Sectia II Hematologie
city: Bucuresti
country: Romania
facility: Spitalul Clinic Coltea, Clinica de Hematologie
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta Bucuresti, Clinica de Hematologie
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of the Ministry of Healthcare of Tatarstan Republic
city: Saint-Petersburg
country: Russian Federation
facility: GBOU VPO "First Saint-Petersburg State Medical University n.a. I.P.Pavlov"
city: Saint-Petersburg
country: Russian Federation
facility: Institute of Pediatric Hematology and Transplantology R.M.Gorbacheva
city: Belgrade
country: Serbia
facility: Clinical Centre of Serbia,Clinic for Hematology
city: Sremska Kamenica
country: Serbia
facility: Oncology Institute of Vojvodina
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: