Study Evaluating Temsirolimus (CCI-779) In Mantle Cell Lymphoma (MCL)
NCT ID: NCT00117598
Last Updated: 2015-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
169 participants
INTERVENTIONAL
2005-05-31
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Temsirolimus (CCI-779)
Temsirolimus 175 mg IV once a week for 3 weeks; followed by 75 mg IV once a week
B
Temsirolimus (CCI-779)
Temsirolimus 175 mg IV once a week for 3 weeks; followed by 25 mg IV once a week
C
Investigator's choice
Any of the following single agent treatments:
1. Fludarabine 25 mg/m2 IV over 30 minutes daily for 5 consecutive days, every 28 days or oral administration, as appropriate.
2. 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
3. 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
4. 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
5. Cladribine 5 mg/m2 IV daily for 5 consecutive days, every 28 days for 2-6 cycles depending on response,
6. 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
7. Prednisone 40 (20-60) mg/m2 PO daily or every other day
8. Dexamethasone 20(20-40) mg PO/IV daily for 5 consecutive days, every 14 - 28 day
Interventions
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Temsirolimus (CCI-779)
Temsirolimus 175 mg IV once a week for 3 weeks; followed by 75 mg IV once a week
Temsirolimus (CCI-779)
Temsirolimus 175 mg IV once a week for 3 weeks; followed by 25 mg IV once a week
Investigator's choice
Any of the following single agent treatments:
1. Fludarabine 25 mg/m2 IV over 30 minutes daily for 5 consecutive days, every 28 days or oral administration, as appropriate.
2. 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
3. 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
4. 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
5. Cladribine 5 mg/m2 IV daily for 5 consecutive days, every 28 days for 2-6 cycles depending on response,
6. 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
7. Prednisone 40 (20-60) mg/m2 PO daily or every other day
8. Dexamethasone 20(20-40) mg PO/IV daily for 5 consecutive days, every 14 - 28 day
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.)
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Little Rock, Arkansas, United States
Pfizer Investigational Site
Fountain Valley, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
New Milford, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Boca Raton, Florida, United States
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Honolulu, Hawaii, United States
Pfizer Investigational Site
Chicago, Illinois, United States
Pfizer Investigational Site
Morristown, New Jersey, United States
Pfizer Investigational Site
Buffalo, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Rochester, New York, United States
Pfizer Investigational Site
Portland, Oregon, United States
Pfizer Investigational Site
Upland, Pennsylvania, United States
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Austin, Texas, United States
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Grapevine, Texas, United States
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Houston, Texas, United States
Pfizer Investigational Site
Temple, Texas, United States
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Seattle, Washington, United States
Pfizer Investigational Site
Buenos Aires, Buenos Aires, Argentina
Pfizer Investigational Site
Córdoba, Córdoba Province, Argentina
Pfizer Investigational Site
Buenos Aires, , Argentina
Pfizer Investigational Site
East Melbourne, Victoria, Australia
Pfizer Investigational Site
Vienna, , Austria
Pfizer Investigational Site
Ghent, Belgium, Belgium
Pfizer Investigational Site
Bruges, , Belgium
Pfizer Investigational Site
Ghent, , Belgium
Pfizer Investigational Site
Leuven, , Belgium
Pfizer Investigational Site
Vila Buarque, São Paulo, Brazil
Pfizer Investigational Site
Porto Alegre - RS, , Brazil
Pfizer Investigational Site
Edmonton, Alberta, Canada
Pfizer Investigational Site
Vancouver, British Columbia, Canada
Pfizer Investigational Site
London, Ontario, Canada
Pfizer Investigational Site
Ottawa, Ontario, Canada
Pfizer Investigational Site
Toronto, Ontario, Canada
Pfizer Investigational Site
Greenfield Park, Quebec, Canada
Pfizer Investigational Site
Montreal, Quebec, Canada
Pfizer Investigational Site
Montreal, Quebec, Canada
Pfizer Investigational Site
Providencia, Santiago Metropolitan, Chile
Pfizer Investigational Site
Beijing, , China
Pfizer Investigational Site
Beijing, , China
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Shanghai, , China
Pfizer Investigational Site
Shanghai, , China
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Shanghai, , China
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Lyon, , France
Pfizer Investigational Site
Paris, , France
Pfizer Investigational Site
Paris, , France
Pfizer Investigational Site
Pierre-Bénite, , France
Pfizer Investigational Site
Strasbourg, , France
Pfizer Investigational Site
Villejuif, , France
Pfizer Investigational Site
Ulm, Baden-Wurttemberg, Germany
Pfizer Investigational Site
Ulm, Baden-Wurttemberg, Germany
Pfizer Investigational Site
Heidelberg, , Germany
Pfizer Investigational Site
Mainz, , Germany
Pfizer Investigational Site
Bologna, Italy, Italy
Pfizer Investigational Site
Roma, Italy, Italy
Pfizer Investigational Site
Catania, , Italy
Pfizer Investigational Site
Milan, , Italy
Pfizer Investigational Site
Rotterdam, , Netherlands
Pfizer Investigational Site
Lublin, , Poland
Pfizer Investigational Site
Warsaw, , Poland
Pfizer Investigational Site
Barcelona, Barcelona, Spain
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, Spain
Pfizer Investigational Site
Madrid, Madrid, Spain
Pfizer Investigational Site
Pamplona, Navarre, Spain
Pfizer Investigational Site
Madrid, , Spain
Pfizer Investigational Site
Lund, , Sweden
Pfizer Investigational Site
Uppsala, , Sweden
Pfizer Investigational Site
Aarau, , Switzerland
Pfizer Investigational Site
Plymouth, Devon, United Kingdom
Pfizer Investigational Site
Southampton, Hants, United Kingdom
Pfizer Investigational Site
Tooting, London, United Kingdom
Pfizer Investigational Site
Sutton, Surrey, United Kingdom
Countries
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References
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Hess G, Coiffier B, Crump M, Gisselbrecht C, Offner F, Romaguera J, Kang L, Moran PJ. Effect of prognostic classification on temsirolimus efficacy and safety in patients with relapsed or refractory mantle cell lymphoma: a retrospective analysis. Exp Hematol Oncol. 2015 Apr 11;4:11. doi: 10.1186/s40164-015-0006-1. eCollection 2015.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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3066K1-305
Identifier Type: -
Identifier Source: org_study_id
NCT00326547
Identifier Type: -
Identifier Source: nct_alias
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