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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Temsirolimus (CCI-779)
Temsirolimus (CCI-779)
Investigator's choice
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

A

B

C

Arm Description

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)
The period from randomization until disease progression, death or date of last contact.

Secondary Outcome Measures

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.

Full Information

First Posted
June 30, 2005
Last Updated
March 10, 2015
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00117598
Brief Title
Study Evaluating Temsirolimus (CCI-779) In Mantle Cell Lymphoma (MCL)
Acronym
OPTIMAL
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Arm Title
C
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Temsirolimus (CCI-779)
Intervention Description
Temsirolimus 175 mg IV once a week for 3 weeks; followed by 75 mg IV once a week
Intervention Type
Drug
Intervention Name(s)
Temsirolimus (CCI-779)
Intervention Description
Temsirolimus 175 mg IV once a week for 3 weeks; followed by 25 mg IV once a week
Intervention Type
Drug
Intervention Name(s)
Investigator's choice
Intervention Description
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
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
The period from randomization until disease progression, death or date of last contact.
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)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Objective Response
Description
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.
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)
Other Pre-specified Outcome Measures:
Title
Overall Survival (OS)
Description
Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.
Time Frame
Baseline up to 5 years
Title
Time to Response
Description
Time between the date of randomization and the first date of objective response for participants with a confirmed 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)
Title
Duration of Response
Description
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.
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)
Title
Time to Failure (TTF)
Description
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).
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)
Title
Time to Tumor Progression (TTP)
Description
TTP: time from randomization to first documentation of objective tumor progression (including recurrence); censored at last valid tumor assessment.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Pfizer Investigational Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024-2828
Country
United States
Facility Name
Pfizer Investigational Site
City
New Milford
State/Province
Connecticut
ZIP/Postal Code
06776
Country
United States
Facility Name
Pfizer Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Pfizer Investigational Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Facility Name
Pfizer Investigational Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Pfizer Investigational Site
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Pfizer Investigational Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10029-6574
Country
United States
Facility Name
Pfizer Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14642-8668
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Pfizer Investigational Site
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Pfizer Investigational Site
City
Grapevine
State/Province
Texas
ZIP/Postal Code
76051
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Pfizer Investigational Site
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1405BWU
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1406FWZ
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Pfizer Investigational Site
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Pfizer Investigational Site
City
Wien
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Pfizer Investigational Site
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Vila Buarque
State/Province
Sao Paulo
ZIP/Postal Code
01221-010
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Porto Alegre - RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Pfizer Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T2M4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Providencia
State/Province
Santiago
Country
Chile
Facility Name
Pfizer Investigational Site
City
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Pfizer Investigational Site
City
Beijing
ZIP/Postal Code
100036
Country
China
Facility Name
Pfizer Investigational Site
City
Shanghai
ZIP/Postal Code
2000025
Country
China
Facility Name
Pfizer Investigational Site
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Pfizer Investigational Site
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Pfizer Investigational Site
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Pfizer Investigational Site
City
Paris Cedex 15
ZIP/Postal Code
75747
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Pfizer Investigational Site
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Pfizer Investigational Site
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Pfizer Investigational Site
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Pfizer Investigational Site
City
Ulm
State/Province
BW
ZIP/Postal Code
89070
Country
Germany
Facility Name
Pfizer Investigational Site
City
Ulm
State/Province
BW
ZIP/Postal Code
89081
Country
Germany
Facility Name
Pfizer Investigational Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Pfizer Investigational Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Pfizer Investigational Site
City
Bologna
ZIP/Postal Code
40128
Country
Italy
Facility Name
Pfizer Investigational Site
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Pfizer Investigational Site
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Pfizer Investigational Site
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Pfizer Investigational Site
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Pfizer Investigational Site
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Southampton
State/Province
Hants
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Tooting
State/Province
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25938001
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3066K1-305&StudyName=Study%20Evaluating%20Temsirolimus%20%28CCI-779%29%20In%20Mantle%20Cell%20Lymphoma%20%28MCL%29
Description
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Study Evaluating Temsirolimus (CCI-779) In Mantle Cell Lymphoma (MCL)

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