Study Evaluating Temsirolimus (CCI-779) In Mantle Cell Lymphoma (MCL)

NCT00117598 | Completed Phase 3 Results DMC

• 1 other identifier: 3066K1-305
• Study Type: interventional
• Target: 169
• Locations: 17 countries
• Sites: 72

Brief Summary

This is an open-label, randomized trial in relapsed refractory subjects with mantle cell lymphoma (MCL).

Conditions

Lymphoma

Keywords

Lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  The period from randomization until disease progression, death or date of last contact.

  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 Outcomes (1)

• Percentage of Participants With Objective Response

  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)

Other Outcomes (5)

• Overall Survival (OS)

  Baseline up to 5 years

• Time to Response

  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)

• Duration of Response

  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)

Study Arms (3)

A

EXPERIMENTAL

Drug: Temsirolimus (CCI-779)

B

EXPERIMENTAL

Drug: Temsirolimus (CCI-779)

C

ACTIVE COMPARATOR

Drug: Investigator's choice

Interventions

Temsirolimus (CCI-779) DRUG

Temsirolimus 175 mg IV once a week for 3 weeks; followed by 75 mg IV once a week

A

Investigator's choice DRUG

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

C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (73)

Pfizer Investigational Site

Little Rock, Arkansas, 72205, United States

Location

Pfizer Investigational Site

Fountain Valley, California, 92708, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90024-2828, United States

Location

Pfizer Investigational Site

New Milford, Connecticut, 06776, United States

Location

Pfizer Investigational Site

Washington D.C., District of Columbia, 20007, United States

Location

Pfizer Investigational Site

Boca Raton, Florida, 33428, United States

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Pfizer Investigational Site

Honolulu, Hawaii, 96813, United States

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Pfizer Investigational Site

Chicago, Illinois, 60612, United States

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Pfizer Investigational Site

Morristown, New Jersey, 07960, United States

Location

Pfizer Investigational Site

Buffalo, New York, 14263, United States

Location

Pfizer Investigational Site

New York, New York, 10029-6574, United States

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Pfizer Investigational Site

Rochester, New York, 14642-8668, United States

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Pfizer Investigational Site

Portland, Oregon, 97227, United States

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Pfizer Investigational Site

Upland, Pennsylvania, 19013, United States

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Pfizer Investigational Site

Austin, Texas, 78705, United States

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Pfizer Investigational Site

Grapevine, Texas, 76051, United States

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Pfizer Investigational Site

Houston, Texas, 77030-4009, United States

Location

Pfizer Investigational Site

Temple, Texas, 76508, United States

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Seattle, Washington, 98101, United States

Location

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Buenos Aires, Buenos Aires, C1406FWZ, Argentina

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Córdoba, Córdoba Province, 5000, Argentina

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Buenos Aires, C1405BWU, Argentina

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East Melbourne, Victoria, 3000, Australia

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Vienna, A-1090, Austria

Location

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Ghent, Belgium, 9000, Belgium

Location

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Bruges, 8000, Belgium

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Vila Buarque, São Paulo, 01221-010, Brazil

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Porto Alegre - RS, 90610-000, Brazil

Location

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Edmonton, Alberta, T6G 1Z2, Canada

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Vancouver, British Columbia, V6Z 1Y6, Canada

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London, Ontario, N6A 4L5, Canada

Location

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M5G 2C4, Canada

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Greenfield Park, Quebec, J4V 2H1, Canada

Location

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Montreal, Quebec, H1T2M4, Canada

Location

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Montreal, Quebec, H4J 1C5, Canada

Location

Pfizer Investigational Site

Providencia, Santiago Metropolitan, Chile

Location

Pfizer Investigational Site

Beijing, 100021, China

Location

Pfizer Investigational Site

Beijing, 100036, China

Location

Pfizer Investigational Site

Shanghai, 2000025, China

Location

Pfizer Investigational Site

Shanghai, 200032, China

Location

Pfizer Investigational Site

Shanghai, 200433, China

Location

Pfizer Investigational Site

Lyon, 69008, France

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Pfizer Investigational Site

Paris, 75475, France

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Pfizer Investigational Site

Paris, 75747, France

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Pfizer Investigational Site

Pierre-Bénite, 69495, France

Location

Pfizer Investigational Site

Strasbourg, 67098, France

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Pfizer Investigational Site

Villejuif, 94805, France

Location

Pfizer Investigational Site

Ulm, Baden-Wurttemberg, 89070, Germany

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Pfizer Investigational Site

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Pfizer Investigational Site

Heidelberg, 69120, Germany

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Pfizer Investigational Site

Mainz, 55131, Germany

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Pfizer Investigational Site

Bologna, Italy, 40128, Italy

Location

Pfizer Investigational Site

Roma, Italy, 00161, Italy

Location

Pfizer Investigational Site

Catania, 95124, Italy

Location

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Milan, 20132, Italy

Location

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Rotterdam, 3015 GD, Netherlands

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Lublin, 20-081, Poland

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Warsaw, 02-781, Poland

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Pfizer Investigational Site

Barcelona, Barcelona, 08035, Spain

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Pfizer Investigational Site

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28041, Spain

Location

Pfizer Investigational Site

Pamplona, Navarre, 31008, Spain

Location

Pfizer Investigational Site

Madrid, 28006, Spain

Location

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Lund, 221 85, Sweden

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Uppsala, 751 85, Sweden

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Aarau, 5001, Switzerland

Location

Pfizer Investigational Site

Plymouth, Devon, PL6 8DH, United Kingdom

Location

Pfizer Investigational Site

Southampton, Hants, SO16 6YD, United Kingdom

Location

Pfizer Investigational Site

Tooting, London, SW17 0QT, United Kingdom

Location

Pfizer Investigational Site

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 25938001 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Lymphoma

Interventions

temsirolimus

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Limitations and Caveats

After the primary analysis was completed, efficacy data was no longer collected nor analyzed; Participants were followed for safety up to 6 months after the last dose of temsirolimus.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: July 7, 2005
• Study Start: May 1, 2005
• Primary Completion: August 1, 2007
• Study Completion: January 1, 2011
• Last Updated: March 30, 2015
• Results First Posted: March 6, 2012

Record last verified: 2015-03

Locations

DE (4); BR (2); NL (1); BE (4); CA (8); SE (2); CH (1); GB (4); CL (1); AU (1); IT (4); US (19); AR (3); CN (5); PL (2); FR (6); ES (5)