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

Lymphoma Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00117598
• Other study ID #: 3066K1-305
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2005
• Last updated: March 10, 2015
• Start date: May 2005
• Est. completion date: January 2011

Study information

• Verified date: March 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Other known NCT identifiers

• NCT00326547

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: January 2011
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell

Intervention

Drug:
• 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: 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

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	Cordoba
Australia	Pfizer Investigational Site	East Melbourne	Victoria
Austria	Pfizer Investigational Site	Wien
Belgium	Pfizer Investigational Site	Brugge
Belgium	Pfizer Investigational Site	Gent
Belgium	Pfizer Investigational Site	Leuven
Brazil	Pfizer Investigational Site	Porto Alegre - RS
Brazil	Pfizer Investigational Site	Vila Buarque	Sao Paulo
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	Greenfield Park	Quebec
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Ottawa	Ontario
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Vancouver	British Columbia
Chile	Pfizer Investigational Site	Providencia	Santiago
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Shanghai
China	Pfizer Investigational Site	Shanghai
China	Pfizer Investigational Site	Shanghai
France	Pfizer Investigational Site	Lyon
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Paris Cedex 15
France	Pfizer Investigational Site	Pierre Benite
France	Pfizer Investigational Site	Strasbourg
France	Pfizer Investigational Site	Villejuif Cedex
Germany	Pfizer Investigational Site	Heidelberg
Germany	Pfizer Investigational Site	Mainz
Germany	Pfizer Investigational Site	Ulm	BW
Germany	Pfizer Investigational Site	Ulm	BW
Italy	Pfizer Investigational Site	Bologna
Italy	Pfizer Investigational Site	Catania
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Roma
Netherlands	Pfizer Investigational Site	Rotterdam
Poland	Pfizer Investigational Site	Lublin
Poland	Pfizer Investigational Site	Warszawa
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	L'Hospitalet de Llobregat	Barcelona
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Pamplona	Navarra
Sweden	Pfizer Investigational Site	Lund
Sweden	Pfizer Investigational Site	Uppsala
Switzerland	Pfizer Investigational Site	Aarau
United Kingdom	Pfizer Investigational Site	Plymouth	Devon
United Kingdom	Pfizer Investigational Site	Southampton	Hants
United Kingdom	Pfizer Investigational Site	Sutton	Surrey
United Kingdom	Pfizer Investigational Site	Tooting	London
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Boca Raton	Florida
United States	Pfizer Investigational Site	Buffalo	New York
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Fountain Valley	California
United States	Pfizer Investigational Site	Grapevine	Texas
United States	Pfizer Investigational Site	Honolulu	Hawaii
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Morristown	New Jersey
United States	Pfizer Investigational Site	New Milford	Connecticut
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Rochester	New York
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Temple	Texas
United States	Pfizer Investigational Site	Upland	Pennsylvania
United States	Pfizer Investigational Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  China,  France,  Germany,  Italy,  Netherlands,  Poland,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall Survival (OS)	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
Other	Time to Response	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)
Other	Duration of Response	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)
Other	Time to Failure (TTF)	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)
Other	Time to Tumor Progression (TTP)	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)
Primary	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	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.	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)

External Links

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