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

Last updated on March 22, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Little Rock, Arkansas, 72205 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Lymphoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.)

NCT00117598
Pfizer
Completed
Study Evaluating Temsirolimus (CCI-779) In Mantle Cell Lymphoma (MCL)

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Study Evaluating Temsirolimus (CCI-779) In Mantle Cell Lymphoma (MCL)
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lymphoma
  • 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
  • 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
  • Experimental: A
    Intervention: Drug: Temsirolimus (CCI-779)
  • Experimental: B
    Intervention: Drug: Temsirolimus (CCI-779)
  • Active Comparator: C
    Intervention: Drug: Investigator's choice
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
169
January 2011
August 2007   (Final data collection date for primary outcome measure)

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.)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   China,   France,   Germany,   Italy,   Netherlands,   Poland,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
 
 
NCT00117598
3066K1-305
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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