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

March 10, 2015 updated by: Pfizer

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

169

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1405BWU
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1406FWZ
        • Pfizer Investigational Site
      • Cordoba, Argentina, 5000
        • Pfizer Investigational Site
  • Australia
    • Victoria
      • East Melbourne, Victoria, Australia, 3000
        • Pfizer Investigational Site
  • Austria
      • Wien, Austria, A-1090
        • Pfizer Investigational Site
  • Belgium
      • Brugge, Belgium, 8000
        • Pfizer Investigational Site
      • Gent, Belgium, 9000
        • Pfizer Investigational Site
      • Leuven, Belgium, 3000
        • Pfizer Investigational Site
  • Brazil
      • Porto Alegre - RS, Brazil, 90610-000
        • Pfizer Investigational Site
    • Sao Paulo
      • Vila Buarque, Sao Paulo, Brazil, 01221-010
        • Pfizer Investigational Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Pfizer Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Pfizer Investigational Site
    • Ontario
      • London, Ontario, Canada, N6A 4L5
        • Pfizer Investigational Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5G 2C4
        • Pfizer Investigational Site
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H4J 1C5
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H1T2M4
        • Pfizer Investigational Site
  • Chile
    • Santiago
      • Providencia, Santiago, Chile
        • Pfizer Investigational Site
  • China
      • Beijing, China, 100021
        • Pfizer Investigational Site
      • Beijing, China, 100036
        • Pfizer Investigational Site
      • Shanghai, China, 200433
        • Pfizer Investigational Site
      • Shanghai, China, 200032
        • Pfizer Investigational Site
      • Shanghai, China, 2000025
        • Pfizer Investigational Site
  • France
      • Lyon, France, 69008
        • Pfizer Investigational Site
      • Paris, France, 75475
        • Pfizer Investigational Site
      • Paris Cedex 15, France, 75747
        • Pfizer Investigational Site
      • Pierre Benite, France, 69495
        • Pfizer Investigational Site
      • Strasbourg, France, 67098
        • Pfizer Investigational Site
      • Villejuif Cedex, France, 94805
        • Pfizer Investigational Site
  • Germany
      • Heidelberg, Germany, 69120
        • Pfizer Investigational Site
      • Mainz, Germany, 55131
        • Pfizer Investigational Site
    • BW
      • Ulm, BW, Germany, 89081
        • Pfizer Investigational Site
      • Ulm, BW, Germany, 89070
        • Pfizer Investigational Site
  • Italy
      • Bologna, Italy, 40128
        • Pfizer Investigational Site
      • Catania, Italy, 95124
        • Pfizer Investigational Site
      • Milano, Italy, 20132
        • Pfizer Investigational Site
      • Roma, Italy, 00161
        • Pfizer Investigational Site
  • Netherlands
      • Rotterdam, Netherlands, 3015 GD
        • Pfizer Investigational Site
  • Poland
      • Lublin, Poland, 20-081
        • Pfizer Investigational Site
      • Warszawa, Poland, 02-781
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08035
        • Pfizer Investigational Site
      • Madrid, Spain, 28006
        • Pfizer Investigational Site
      • Madrid, Spain, 28041
        • Pfizer Investigational Site
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Pfizer Investigational Site
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Pfizer Investigational Site
  • Sweden
      • Lund, Sweden, 221 85
        • Pfizer Investigational Site
      • Uppsala, Sweden, 751 85
        • Pfizer Investigational Site
  • Switzerland
      • Aarau, Switzerland, 5001
        • Pfizer Investigational Site
  • United Kingdom
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
        • Pfizer Investigational Site
    • Hants
      • Southampton, Hants, United Kingdom, SO16 6YD
        • Pfizer Investigational Site
    • London
      • Tooting, London, United Kingdom, SW17 0QT
        • Pfizer Investigational Site
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Pfizer Investigational Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Pfizer Investigational Site
    • California
      • Fountain Valley, California, United States, 92708
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90024-2828
        • Pfizer Investigational Site
    • Connecticut
      • New Milford, Connecticut, United States, 06776
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Pfizer Investigational Site
    • Florida
      • Boca Raton, Florida, United States, 33428
        • Pfizer Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Pfizer Investigational Site
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Pfizer Investigational Site
    • New York
      • Buffalo, New York, United States, 14263
        • Pfizer Investigational Site
      • New York, New York, United States, 10029-6574
        • Pfizer Investigational Site
      • Rochester, New York, United States, 14642-8668
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97227
        • Pfizer Investigational Site
    • Pennsylvania
      • Upland, Pennsylvania, United States, 19013
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, United States, 78705
        • Pfizer Investigational Site
      • Grapevine, Texas, United States, 76051
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77030-4009
        • Pfizer Investigational Site
      • Temple, Texas, United States, 76508
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, United States, 98101
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: Temsirolimus (CCI-779)
Temsirolimus 175 mg IV once a week for 3 weeks; followed by 75 mg IV once a week
Drug: Temsirolimus (CCI-779)
Temsirolimus 175 mg IV once a week for 3 weeks; followed by 25 mg IV once a week
Experimental: B
Drug: Temsirolimus (CCI-779)
Temsirolimus 175 mg IV once a week for 3 weeks; followed by 75 mg IV once a week
Drug: Temsirolimus (CCI-779)
Temsirolimus 175 mg IV once a week for 3 weeks; followed by 25 mg IV once a week
Active Comparator: C
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: 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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Objective Response
Time Frame: 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)
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Baseline up to 5 years
Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.
Baseline up to 5 years
Time to Response
Time Frame: 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)
Time between the date of randomization and the first date of objective response for participants with a confirmed 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)
Duration of Response
Time Frame: 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)
Time from the first documentation of objective tumor response to first date that recurrence or progressive disease (PD) was objectively documented; censored at last valid tumor assessment.
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)
Time to Failure (TTF)
Time Frame: 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)
TTF is defined as the time from randomization to the date of the first documentation of Progressive Disease (PD), the date of treatment discontinuation except completion of treatment, or date of death (any cause).
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)
Time to Tumor Progression (TTP)
Time Frame: 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)
TTP: time from randomization to first documentation of objective tumor progression (including recurrence); censored at last valid tumor assessment.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

June 30, 2005

First Submitted That Met QC Criteria

June 30, 2005

First Posted (Estimate)

July 7, 2005

Study Record Updates

Last Update Posted (Estimate)

March 30, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3066K1-305

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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