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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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) - The period from randomization until disease progression, death or date of last contact.
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 - Assessment of complete or partial response (CR, PR) or uncomplete response (CRu) using Response Evaluation Criteria in Solid Tumors. CR: 1) No disease evident. 2) Lymph node, nodal mass regressed to normal size. 3) Previously enlarged organ ? size. 4) Bone marrow clear on repeat aspirate, biopsy. CRu: CR 1 and 3, at least 1 of following: Lymph node regressed >75%. Bone marrow ? number or aggregate size, no cytologic/architectural atypia. PR: =50% ? index lesion, no size ? in other nodes, liver, spleen. Splenic and hepatic nodule regressed =50%. No new disease.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
State/province [2] 0 0
California
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United States of America
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Connecticut
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United States of America
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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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United States of America
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Illinois
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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Oregon
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United States of America
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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
Country [16] 0 0
Austria
State/province [16] 0 0
Wien
Country [17] 0 0
Belgium
State/province [17] 0 0
Brugge
Country [18] 0 0
Belgium
State/province [18] 0 0
Gent
Country [19] 0 0
Belgium
State/province [19] 0 0
Leuven
Country [20] 0 0
Brazil
State/province [20] 0 0
Sao Paulo
Country [21] 0 0
Brazil
State/province [21] 0 0
Porto Alegre - RS
Country [22] 0 0
Canada
State/province [22] 0 0
Alberta
Country [23] 0 0
Canada
State/province [23] 0 0
British Columbia
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
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Canada
State/province [25] 0 0
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
State/province [28] 0 0
Shanghai
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France
State/province [29] 0 0
Lyon
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France
State/province [30] 0 0
Paris Cedex 15
Country [31] 0 0
France
State/province [31] 0 0
Paris
Country [32] 0 0
France
State/province [32] 0 0
Pierre Benite
Country [33] 0 0
France
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Strasbourg
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France
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Villejuif Cedex
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Germany
State/province [35] 0 0
BW
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Germany
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Heidelberg
Country [37] 0 0
Germany
State/province [37] 0 0
Mainz
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Italy
State/province [38] 0 0
Bologna
Country [39] 0 0
Italy
State/province [39] 0 0
Catania
Country [40] 0 0
Italy
State/province [40] 0 0
Milano
Country [41] 0 0
Italy
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Roma
Country [42] 0 0
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
State/province [53] 0 0
London
Country [54] 0 0
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/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
Other publications