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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)


Phase 3
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

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)


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.)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Description:

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

Outcome 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)

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3066K1-305

NCT ID:

NCT00117598

Start Date:

May 2005

Completion Date:

January 2011

Related Keywords:

  • Lymphoma
  • Lymphoma
  • Lymphoma
  • Lymphoma, Mantle-Cell

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteNorth Little Rock, Arkansas  72117
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteEugene, Oregon  97401
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteFarmington, Connecticut  06030-3805
Pfizer Investigational SiteLivingston, New Jersey  07039
Pfizer Investigational SiteWashington, District of Columbia  20007-2197
Pfizer Investigational SiteHonolulu, Hawaii  96813