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

Last updated on May 22, 2018

FOR MORE INFORMATION
Study Location
Mercy Research Institute
Miami, Florida, 33133 United States
Contact
1-800-718-1021
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.

NCT01180049
Pfizer
Active, not recruiting
Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma

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Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma
A Randomized Phase 4 Study Comparing 2 Intravenous Temsirolimus (Temsr) Regimens In Subjects With Relapsed, Refractory Mantle Cell Lymphoma
This study will compare the effectiveness and safety of two different doses of temsirolimus (Torisel).
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma
  • 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
  • Active Comparator: temsirolimus (Torisel) 175mg weekly x 3, then 75mg weekly
    Intervention: Drug: temsirolimus
  • Active Comparator: temsirolimus (Torisel) 75mg weekly
    Intervention: Drug: temsirolimus
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90
June 15, 2018
November 12, 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Czechia,   France,   Germany,   Italy,   Korea, Republic of,   Poland,   Romania,   Russian Federation,   Serbia,   United States
Belgium,   Bulgaria,   Czech Republic,   Hong Kong,   Hungary,   Netherlands
 
NCT01180049
3066K1-4438
B1771007 ( Other Identifier: Alias Study Number )
2009-015498-11 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

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

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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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