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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01180049




Registration number
NCT01180049
Ethics application status
Date submitted
9/08/2010
Date registered
11/08/2010

Titles & IDs
Public title
Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma
Scientific title
A RANDOMIZED PHASE 4 STUDY COMPARING 2 INTRAVENOUS TEMSIROLIMUS (TEMSR) REGIMENS IN SUBJECTS WITH RELAPSED, REFRACTORY MANTLE CELL LYMPHOMA
Secondary ID [1] 0 0
B1771007
Secondary ID [2] 0 0
3066K1-4438
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Hodgkin's Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - temsirolimus
Treatment: Drugs - temsirolimus

Active comparator: temsirolimus (Torisel) 175mg weekly x 3, then 75mg weekly -

Active comparator: temsirolimus (Torisel) 75mg weekly -


Treatment: Drugs: temsirolimus
175mg IV once a week for first 3 weeks, followed by 75mg IV once a week until disease progression, provided that patient is tolerating treatment and getting clinical benefit

Treatment: Drugs: temsirolimus
75mg IV once a week until until disease progression, provided that patient is tolerating treatment and getting clinical benefit
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Independently Assessed Progression-free Survival (PFS)
Timepoint [1] 0 0
From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From randomization date until death due to any cause (average follow up done for 56.1 months)
Secondary outcome [2] 0 0
Independent Assessment - Objective Response Rate (ORR = CR + PR)
Timepoint [2] 0 0
From randomization date until end of treatment (average follow up done for 15 months)
Secondary outcome [3] 0 0
Investigator's Assessment ORR (ORR = CR + PR)
Timepoint [3] 0 0
From randomization date until end of treatment (average follow up done for 15 months)
Secondary outcome [4] 0 0
Investigator Assessed PFS
Timepoint [4] 0 0
From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)
Secondary outcome [5] 0 0
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)
Timepoint [5] 0 0
From screening up to a maximum of 57.1 months
Secondary outcome [6] 0 0
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)
Timepoint [6] 0 0
From screening up to a maximum of 57.1 months
Secondary outcome [7] 0 0
Quantify the Potential Effect of TEMSR on AUC and Cmax
Timepoint [7] 0 0
From one week predose (Day -7, -4hr, -8hr, -48hr) upto 2 weeks post dose (4hr, 8hr, 48hr and Day 8)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2018
Sample size
Target
Accrual to date
Final
101
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC
Recruitment hospital [1] 0 0
St George Hospital - Kogarah
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [4] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [5] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
7000 - Hobart
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
New Jersey
Country [3] 0 0
United States of America
State/province [3] 0 0
Oklahoma
Country [4] 0 0
United States of America
State/province [4] 0 0
Washington
Country [5] 0 0
Czechia
State/province [5] 0 0
Czech Republic
Country [6] 0 0
Czechia
State/province [6] 0 0
Praha 10
Country [7] 0 0
Czechia
State/province [7] 0 0
Praha 2
Country [8] 0 0
France
State/province [8] 0 0
Vandoeuvre les Nancy
Country [9] 0 0
Germany
State/province [9] 0 0
Aachen
Country [10] 0 0
Germany
State/province [10] 0 0
Mainz
Country [11] 0 0
Italy
State/province [11] 0 0
Catania
Country [12] 0 0
Italy
State/province [12] 0 0
Modena
Country [13] 0 0
Italy
State/province [13] 0 0
Torino
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Seoul
Country [15] 0 0
Poland
State/province [15] 0 0
Krakow
Country [16] 0 0
Romania
State/province [16] 0 0
Bucuresti
Country [17] 0 0
Russian Federation
State/province [17] 0 0
Kazan
Country [18] 0 0
Russian Federation
State/province [18] 0 0
Saint-Petersburg
Country [19] 0 0
Serbia
State/province [19] 0 0
Belgrade
Country [20] 0 0
Serbia
State/province [20] 0 0
Sremska Kamenica

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01180049