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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01180049
First received: August 9, 2010
Last updated: June 29, 2017
Last verified: June 2017
  Purpose
This study will compare the effectiveness and safety of two different doses of temsirolimus (Torisel).

Condition Intervention Phase
Non-Hodgkin's Lymphoma (NHL) Drug: temsirolimus Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase 4 Study Comparing 2 Intravenous Temsirolimus (Temsr) Regimens In Subjects With Relapsed, Refractory Mantle Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Independently Assessed Progression-free Survival (PFS) [ Time Frame: From randomization date to the date of first documentation of progression or death (average follow up done for 15 months) ]

    PFS is defined as the time from randomization to first documentation of disease progression by the independent assessor or to death due to any cause, whichever occurred first.

    PFS = (earliest date of progression or death due to any cause- randomization date+1)/30.4.

    PFS assessment was done using EMA guidelines for sensitivity analysis censoring.

    Participants who were alive and progression-free at the time of analysis were censored on the date of last assessment; participants without adequate baseline assessment or without post-baseline assessments were censored on the randomization date; participants who died or progressed after 2 or more missed visits were censored on the date of last tumor assessment prior to the missing visit; and participants who started new anti-cancer therapy prior to death or progression were censored on the date of last tumor assessment prior to the start of anti-tumor treatment.



Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: From randomization date until death (average follow up done for 18.6 months) ]
    OS is defined as the time from the date of randomization to the date of death due to any cause.

  • Independent Assessment - Objective Response Rate (ORR = CR + PR) [ Time Frame: From randomization date until end of treatment (average follow up done for 15 months) ]

    ORR is defined as the percentage of participants with confirmed CR or PR according to the Cheson Criteria relative to all randomized Participants. Tumor responses were determined using information from objective measurements from computed tomography information including B-symptom evaluation, physical examination, ECOG performance status, assessment of liver and spleen, laboratory assessments such as bone marrow biopsies and/or aspirates, biochemical markers of disease activity and hematology results.

    Participants who did not have on-study radiographic tumor re-evaluation or who died, progressed or dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the (CT) scans, as well as clinical assessment of ORR.


  • Investigator's Assessment ORR (ORR = CR + PR) [ Time Frame: From randomization date until end of treatment (average follow up done for 15 months) ]

    ORR is defined as the percentage of participants with confirmed CR or PR according to the Cheson Criteria relative to all randomized Participants. Tumor responses were determined using information from objective measurements from computed tomography information including B-symptom evaluation, physical examination, ECOG performance status, assessment of liver and spleen, laboratory assessments such as bone marrow biopsies and/or aspirates, biochemical markers of disease activity and hematology results.

    Participants who did not have on-study radiographic tumor re-evaluation or who died, progressed or dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the (CT) scans, as well as clinical assessment of ORR.


  • Investigator Assessed PFS [ Time Frame: From randomization date to the date of first documentation of progression or death (average follow up done for 15 months) ]

    PFS is defined as the time from randomization to first documentation of disease progression by the independent assessor or to death due to any cause, whichever occurred first.

    PFS = (earliest date of progression or death due to any cause- randomization date+1)/30.4.

    PFS assessment was done using EMA guidelines for sensitivity analysis censoring.

    Participants who were alive and progression-free at the time of analysis were censored on the date of last assessment; participants without adequate baseline assessment or without post-baseline assessments were censored on the randomization date; participants who died or progressed after 2 or more missed visits were censored on the date of last tumor assessment prior to the missing visit; and participants who started new anti-cancer therapy prior to death or progression were censored on the date of last tumor assessment prior to the start of anti-tumor treatment.


  • Percentage of Participants With Treatment-emergent Infection- Related AEs [ Time Frame: From screening (Day -28 to Day -1) until end of treatment (within 30 days of last TEMSR infusion) ]
    To assess the safety through percentages of participants with treatment-emergent infection- related AEs TEAE: Treatment start date ≤ adverse event start date or adverse event worsened with respect to grade after treatment started

  • Percentage of Participants With Treatment-emergent Bleeding-related AEs [ Time Frame: From screening (Day -28 to Day -1) until end of treatment (within 30 days of last TEMSR infusion) ]

    To assess the safety through percentage of participants with treatment-emergent bleeding-related AEs (Grade 2 or Higher).

    TEAE: Treatment start date ≤ adverse event start date or adverse event worsened with respect to grade after treatment started


  • Quantify the Potential Effect of TEMSR on AUC and Cmax [ Time Frame: From one week predose (Day -7, -4hr, -8hr, -48hr) upto 2 weeks post dose (4hr, 8hr, 48hr and Day 8) ]

    Potential TEMSR effects were investigated by calculating the ratio of AUCs with and without concomitant TEMSR from the model-estimated effect of TEMSR on apparent clearance (CL/F) values and using individual ratios of observed Cmax values with and without concomitant temsirolimus, for both parent and metabolite. The AUC mean ratio was calculated as 1 / mean shift on apparent clearance from TEMSR, and the 90% CI of the AUC ratios was calculated as 1 / 90% CI of the shift on apparent clearance from TEMSR.

    AUC: Area under plasma concentration-time curve from time zero to infinity Cmax: Characterization of maximum observed plasma concentration



Enrollment: 90
Actual Study Start Date: March 10, 2011
Estimated Study Completion Date: June 15, 2018
Primary Completion Date: November 12, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: temsirolimus (Torisel) 175mg weekly x 3, then 75mg weekly 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
Active Comparator: temsirolimus (Torisel) 75mg weekly Drug: temsirolimus
75mg IV once a week until until disease progression, provided that patient is tolerating treatment and getting clinical benefit
Other Name: Torisel

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01180049

  Show 32 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01180049     History of Changes
Other Study ID Numbers: 3066K1-4438
B1771007 ( Other Identifier: Alias Study Number )
2009-015498-11 ( EudraCT Number )
Study First Received: August 9, 2010
Results First Received: November 4, 2016
Last Updated: June 29, 2017

Keywords provided by Pfizer:
Mantle Cell Lymphoma
non-Hodgkin lymphoma (NHL)
temsirolimus

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents

ClinicalTrials.gov processed this record on August 17, 2017