Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01180049
Registration number
NCT01180049
Ethics application status
Date submitted
9/08/2010
Date registered
11/08/2010
Date last updated
20/05/2019
Titles & IDs
Public title
Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma
Query!
Scientific title
A RANDOMIZED PHASE 4 STUDY COMPARING 2 INTRAVENOUS TEMSIROLIMUS (TEMSR) REGIMENS IN SUBJECTS WITH RELAPSED, REFRACTORY MANTLE CELL LYMPHOMA
Query!
Secondary ID [1]
0
0
B1771007
Query!
Secondary ID [2]
0
0
3066K1-4438
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Non-Hodgkin's Lymphoma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Query!
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Independently Assessed Progression-free Survival (PFS)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)
Query!
Secondary outcome [1]
0
0
Overall Survival (OS)
Query!
Assessment method [1]
0
0
OS is defined as the time from the date of randomization to the date of death due to any cause.
Query!
Timepoint [1]
0
0
From randomization date until death due to any cause (average follow up done for 56.1 months)
Query!
Secondary outcome [2]
0
0
Independent Assessment - Objective Response Rate (ORR = CR + PR)
Query!
Assessment method [2]
0
0
ORR is defined as the percentage of participants with confirmed CR or PR according to the Cheson Criteria relative to all randomized Participants. Tumor responses were determined using information from objective measurements from computed tomography information including B-symptom evaluation, physical examination, ECOG performance status, assessment of liver and spleen, laboratory assessments such as bone marrow biopsies and/or aspirates, biochemical markers of disease activity and hematology results.
Participants who did not have on-study radiographic tumor re-evaluation or who died, progressed or dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the (CT) scans, as well as clinical assessment of ORR.
Query!
Timepoint [2]
0
0
From randomization date until end of treatment (average follow up done for 15 months)
Query!
Secondary outcome [3]
0
0
Investigator's Assessment ORR (ORR = CR + PR)
Query!
Assessment method [3]
0
0
ORR is defined as the percentage of participants with confirmed CR or PR according to the Cheson Criteria relative to all randomized Participants. Tumor responses were determined using information from objective measurements from computed tomography information including B-symptom evaluation, physical examination, ECOG performance status, assessment of liver and spleen, laboratory assessments such as bone marrow biopsies and/or aspirates, biochemical markers of disease activity and hematology results.
Participants who did not have on-study radiographic tumor re-evaluation or who died, progressed or dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the (CT) scans, as well as clinical assessment of ORR.
Query!
Timepoint [3]
0
0
From randomization date until end of treatment (average follow up done for 15 months)
Query!
Secondary outcome [4]
0
0
Investigator Assessed PFS
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)
Query!
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)
Query!
Assessment method [5]
0
0
An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Treatment emergent adverse event=as an event that emerged during treatment period that was absent before treatment, or worsened during treatment period relative to pretreatment state. Treatment-emergent infection-related AEs included events: pneumonia, bronchitis, infection, herpes simplex, oral candidiasis and sepsis. Grading by NCI CTCAE Version 3.0.: Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening; urgent intervention indicated; Grade 5= death.
Query!
Timepoint [5]
0
0
From screening up to a maximum of 57.1 months
Query!
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)
Query!
Assessment method [6]
0
0
An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Treatment emergent adverse event=as an event that emerged during treatment period that was absent before treatment, or worsened during treatment period relative to pretreatment state. Treatment-emergent bleeding related AEs included events: epistaxis and ecchymosis. AE were assessed according to maximum severity grading based on NCI CTCAE Version 4.03.Grade 1=mild; Grade 2=moderate; within normal limits. Grade 3=severe or medically significant but not immediately life-threatening; Grade 4=life-threatening or disabling; urgent intervention indicated; Grade 5=death.
Query!
Timepoint [6]
0
0
From screening up to a maximum of 57.1 months
Query!
Secondary outcome [7]
0
0
Quantify the Potential Effect of TEMSR on AUC and Cmax
Query!
Assessment method [7]
0
0
Potential TEMSR effects were investigated by calculating the ratio of AUCs with and without concomitant TEMSR from the model-estimated effect of TEMSR on apparent clearance (CL/F) values and using individual ratios of observed Cmax values with and without concomitant temsirolimus, for both parent and metabolite. The AUC mean ratio was calculated as 1 / mean shift on apparent clearance from TEMSR, and the 90% CI of the AUC ratios was calculated as 1 / 90% CI of the shift on apparent clearance from TEMSR.
AUC: Area under plasma concentration-time curve from time zero to infinity Cmax: Characterization of maximum observed plasma concentration
Query!
Timepoint [7]
0
0
From one week predose (Day -7, -4hr, -8hr, -48hr) upto 2 weeks post dose (4hr, 8hr, 48hr and Day 8)
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 4
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/03/2011
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/06/2018
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
101
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC
Query!
Recruitment hospital [1]
0
0
St George Hospital - Kogarah
Query!
Recruitment hospital [2]
0
0
Royal Adelaide Hospital - Adelaide
Query!
Recruitment hospital [3]
0
0
Royal Hobart Hospital - Hobart
Query!
Recruitment hospital [4]
0
0
Box Hill Hospital - Box Hill
Query!
Recruitment hospital [5]
0
0
The Alfred Hospital - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [2]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [3]
0
0
7000 - Hobart
Query!
Recruitment postcode(s) [4]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [5]
0
0
3004 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Florida
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
New Jersey
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Oklahoma
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Washington
Query!
Country [5]
0
0
Czechia
Query!
State/province [5]
0
0
Czech Republic
Query!
Country [6]
0
0
Czechia
Query!
State/province [6]
0
0
Praha 10
Query!
Country [7]
0
0
Czechia
Query!
State/province [7]
0
0
Praha 2
Query!
Country [8]
0
0
France
Query!
State/province [8]
0
0
Vandoeuvre les Nancy
Query!
Country [9]
0
0
Germany
Query!
State/province [9]
0
0
Aachen
Query!
Country [10]
0
0
Germany
Query!
State/province [10]
0
0
Mainz
Query!
Country [11]
0
0
Italy
Query!
State/province [11]
0
0
Catania
Query!
Country [12]
0
0
Italy
Query!
State/province [12]
0
0
Modena
Query!
Country [13]
0
0
Italy
Query!
State/province [13]
0
0
Torino
Query!
Country [14]
0
0
Korea, Republic of
Query!
State/province [14]
0
0
Seoul
Query!
Country [15]
0
0
Poland
Query!
State/province [15]
0
0
Krakow
Query!
Country [16]
0
0
Romania
Query!
State/province [16]
0
0
Bucuresti
Query!
Country [17]
0
0
Russian Federation
Query!
State/province [17]
0
0
Kazan
Query!
Country [18]
0
0
Russian Federation
Query!
State/province [18]
0
0
Saint-Petersburg
Query!
Country [19]
0
0
Serbia
Query!
State/province [19]
0
0
Belgrade
Query!
Country [20]
0
0
Serbia
Query!
State/province [20]
0
0
Sremska Kamenica
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Pfizer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study will compare the effectiveness and safety of two different doses of temsirolimus
(Torisel).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01180049
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01180049
Download to PDF