Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma

NCT01180049

Last updated date
Study Location
Mercy Research Institute
Miami, Florida, 33133, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Hodgkin's 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

- Have confirmed mantle cell lymphoma diagnosis.

- Have measurable disease.

- Have received at least 2 prior treatment, which may include stem cell transplant.

- Have adequate organ and bone marrow function.

- There are other criteria--please discuss with your doctor.

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


- Had any prior treatment with temsirolimus or mTOR inhibitor.


- Had allogeneic stem cell transplant within last 6 months and on immunosuppressive
therapy.


- Has active or untreated brain or central nervous system metastases.


- There are other criteria--please discuss with your doctor.

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Non-Hodgkin's LymphomaComparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma NCT01180049
  1. Miami, Florida
  2. East Orange, New Jersey
  3. Oklahoma City, Oklahoma
  4. Oklahoma City, Oklahoma
  5. Seattle, Washington
  6. Seattle, Washington
  7. Kogarah, New South Wales
  8. Adelaide, South Australia
  9. Hobart, Tasmania
  10. Box Hill, Victoria
  11. Melbourne, Victoria
  12. Praha 10, Czech Republic
  13. Praha 10,
  14. Praha 2,
  15. Vandoeuvre les Nancy,
  16. Aachen,
  17. Mainz,
  18. Catania,
  19. Modena,
  20. Torino,
  21. Seoul,
  22. Seoul,
  23. Krakow,
  24. Bucuresti,
  25. Bucuresti,
  26. Bucuresti,
  27. Kazan,
  28. Saint-Petersburg,
  29. Saint-Petersburg,
  30. Belgrade,
  31. Sremska Kamenica,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma
Official Title  ICMJE A RANDOMIZED PHASE 4 STUDY COMPARING 2 INTRAVENOUS TEMSIROLIMUS (TEMSR) REGIMENS IN SUBJECTS WITH RELAPSED, REFRACTORY MANTLE CELL LYMPHOMA
Brief Summary This study will compare the effectiveness and safety of two different doses of temsirolimus (Torisel).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Hodgkin's Lymphoma
Intervention  ICMJE
  • Drug: temsirolimus
    175mg IV once a week for first 3 weeks, followed by 75mg IV once a week until disease progression, provided that patient is tolerating treatment and getting clinical benefit
    Other Name: Torisel
  • Drug: temsirolimus
    75mg IV once a week until until disease progression, provided that patient is tolerating treatment and getting clinical benefit
    Other Name: Torisel
Study Arms  ICMJE
  • Active Comparator: temsirolimus (Torisel) 175mg weekly x 3, then 75mg weekly
    Intervention: Drug: temsirolimus
  • Active Comparator: temsirolimus (Torisel) 75mg weekly
    Intervention: Drug: temsirolimus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2018)
101
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2010)
100
Actual Study Completion Date  ICMJE June 2018
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have confirmed mantle cell lymphoma diagnosis.
  • Have measurable disease.
  • Have received at least 2 prior treatment, which may include stem cell transplant.
  • Have adequate organ and bone marrow function.
  • There are other criteria--please discuss with your doctor.

Exclusion Criteria:

  • Had any prior treatment with temsirolimus or mTOR inhibitor.
  • Had allogeneic stem cell transplant within last 6 months and on immunosuppressive therapy.
  • Has active or untreated brain or central nervous system metastases.
  • There are other criteria--please discuss with your doctor.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Czechia,   France,   Germany,   Italy,   Korea, Republic of,   Poland,   Romania,   Russian Federation,   Serbia,   United States
Removed Location Countries Belgium,   Bulgaria,   Czech Republic,   Hong Kong,   Hungary,   Netherlands
 
Administrative Information
NCT Number  ICMJE NCT01180049
Other Study ID Numbers  ICMJE 3066K1-4438
B1771007 ( Other Identifier: Alias Study Number )
2009-015498-11 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP