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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00117598




Registration number
NCT00117598
Ethics application status
Date submitted
30/06/2005
Date registered
7/07/2005
Date last updated
30/03/2015

Titles & IDs
Public title
Study Evaluating Temsirolimus (CCI-779) In Mantle Cell Lymphoma (MCL)
Scientific title
An Open-Label, Randomized, Phase 3 Trial Of Intravenous Temsirolimus (CCI-779) At Two Dose Levels Compared To Investigator's Choice Therapy In Relapsed, Refractory Subjects With Mantle Cell Lymphoma (MCL)
Secondary ID [1] 0 0
3066K1-305
Universal Trial Number (UTN)
Trial acronym
OPTIMAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 (CCI-779)
Treatment: Drugs - Temsirolimus (CCI-779)
Treatment: Drugs - Investigator's choice

Experimental: A -

Experimental: B -

Active Comparator: C -


Treatment: Drugs: Temsirolimus (CCI-779)
Temsirolimus 175 mg IV once a week for 3 weeks; followed by 75 mg IV once a week

Treatment: Drugs: Temsirolimus (CCI-779)
Temsirolimus 175 mg IV once a week for 3 weeks; followed by 25 mg IV once a week

Treatment: Drugs: Investigator's choice
Any of the following single agent treatments:
Fludarabine 25 mg/m2 IV over 30 minutes daily for 5 consecutive days, every 28 days or oral administration, as appropriate.
Chlorambucil 0.1 (0.1-0.2) mg/kg PO daily for 3 to 6 weeks as required OR 0.4 (0.3 0.8) mg/kg PO every 21 to 28 days
Gemcitabine 1 gm/m2 IV over 30 minutes on days 1, 8 and 15 every 28 days or day 1 and day 8 every 21 days
Cyclophosphamide 300 (200-450) mg/m2 PO daily for 5 consecutive days every 21 to 28 days, OR 600 (400-1200) mg/m2 IV every 21 to 28 days
Cladribine 5 mg/m2 IV daily for 5 consecutive days, every 28 days for 2-6 cycles depending on response,
Etoposide 50 (50-150) mg/m2 IV daily for 3-5 days every 21 to 28 days OR 100 (50 300) mg/m2 PO daily for 3-5 days every 21 to 28 days
Prednisone 40 (20-60) mg/m2 PO daily or every other day
Dexamethasone 20(20-40) mg PO/IV daily for 5 consecutive days, every 14 - 28 day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
Secondary outcome [1] 0 0
Percentage of Participants With Objective Response
Timepoint [1] 0 0
Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)

Eligibility
Key inclusion criteria
- Mantle cell lymphoma (MCL) confirmed with histology, immunophenotype, and cyclin D1
analysis

- Received 2 to 7 prior therapies which may include hematopoietic stem cell transplant
(i.e. induction + consolidation + maintenance)

- Prior treatment with an alkylating agent and an anthracycline, rituximab, individually
or in combination, and status that is at least one of the following:

- Primary disease refractory to at least 2 regimens;

- Refractory to at least 1 regimen after first relapse;

- Refractory or untreated after second or greater relapse;

- Refractory to first line and relapsed after second line. Chemotherapy combinations may
include, but are not limited to: CHOP (Cyclophosphamide, doxorubicin, vincristine,
prednisone), R-CHOP (Rituximab, Cyclophosphamide, doxorubicin, vincristine,
prednisone), FCM (Fludarabine, cyclophosphamide, mitoxantrone), R-FCM
(Rituximab,Fludarabine, cyclophosphamide, mitoxantrone), ICE(Ifosfamide, carboplatin,
etoposide), DHAP (Dexamethasone, cisplatin, cytarabine) and hyper-CVAD
(Cyclophosphamide, doxorubicin, vincristine, dexamethasone).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects who are less than or equal to six month from allogeneic hematopoietic stem
cell transplant and who are on immunosuppressive therapy or have evidence of graft
versus host disease

- Prior investigational therapy within 3 weeks of first dose. Investigational therapy is
defined as treatment that is not approved for any indication.

- Active central nervous system (CNS) metastases, as indicated by clinical symptoms,
cerebral edema, requirement for corticosteroids and/or progressive growth. (Treated
CNS metastases must be stable for > 2 weeks prior to Day 1.)

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 3
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
1/05/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2011
Sample size
Target
Accrual to date
Final
169
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - East Melbourne
Recruitment postcode(s) [1] 0 0
3000 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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United States of America
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California
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United States of America
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Connecticut
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District of Columbia
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United States of America
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Florida
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United States of America
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Hawaii
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Illinois
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New Jersey
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New York
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Oregon
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Pennsylvania
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United States of America
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Texas
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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Austria
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Wien
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Belgium
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Brugge
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Belgium
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Gent
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Belgium
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Leuven
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Brazil
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Sao Paulo
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Brazil
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Porto Alegre - RS
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Santiago
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China
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Beijing
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China
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Shanghai
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France
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Lyon
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France
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Paris Cedex 15
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France
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Paris
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France
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Pierre Benite
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France
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Strasbourg
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France
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Villejuif Cedex
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Germany
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BW
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Germany
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Heidelberg
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Germany
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Mainz
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Italy
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Bologna
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Italy
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Catania
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Italy
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Milano
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Italy
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Roma
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Netherlands
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Rotterdam
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Poland
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Lublin
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Poland
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Warszawa
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Spain
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Barcelona
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Spain
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Navarra
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Spain
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Madrid
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Sweden
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Lund
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Sweden
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Uppsala
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Switzerland
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Aarau
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United Kingdom
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Devon
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United Kingdom
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Hants
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United Kingdom
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London
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United Kingdom
State/province [54] 0 0
Surrey

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

Ethics approval
Ethics application status

Summary
Brief summary
This is an open-label, randomized trial in relapsed refractory subjects with mantle cell
lymphoma (MCL).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00117598
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00117598