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

NCT01180049 | Completed Phase 4 Results DMC

• 3 other identifiers: 3066K1-4438B17710072009-015498-11
• Study Type: interventional
• Target: 101
• Locations: 11 countries
• Sites: 31

Brief Summary

This study will compare the effectiveness and safety of two different doses of temsirolimus (Torisel).

Conditions

Non-Hodgkin's Lymphoma

Keywords

Mantle Cell Lymphoma; Non-Hodgkin's Lymphoma; temsirolimus

Outcome Measures

Primary Outcomes (1)

• Independently Assessed Progression-free Survival (PFS)

  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.

  From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)

Secondary Outcomes (7)

• Overall Survival (OS)

  From randomization date until death due to any cause (average follow up done for 56.1 months)

• Independent Assessment - Objective Response Rate (ORR = CR + PR)

  From randomization date until end of treatment (average follow up done for 15 months)

• Investigator's Assessment ORR (ORR = CR + PR)

  From randomization date until end of treatment (average follow up done for 15 months)

• Investigator Assessed PFS

  From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)

• Percentage of Participants With Treatment-Emergent Infection- Related Adverse Events (AEs) With Grade 2 or Higher as Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)

  From screening up to a maximum of 57.1 months

Study Arms (2)

temsirolimus (Torisel) 175mg weekly x 3, then 75mg weekly

ACTIVE COMPARATOR

Drug: temsirolimus

temsirolimus (Torisel) 75mg weekly

ACTIVE COMPARATOR

Drug: temsirolimus

Interventions

temsirolimus DRUG

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

Also known as: Torisel

temsirolimus (Torisel) 175mg weekly x 3, then 75mg weekly

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (31)

Mercy Research Institute

Miami, Florida, 33133, United States

Location

Veterans Affairs New Jersey Healthcare System-Hematology/Oncology Section (111)

East Orange, New Jersey, 07018, United States

Location

Mercy Clinic Oklahoma Communities dba Mercy Clinic Oncology/Hematology-McAuley

Oklahoma City, Oklahoma, 73120, United States

Location

Mercy Hospital Oklahoma City-Oncology Infusion

Oklahoma City, Oklahoma, 73120, United States

Location

Amy Shen, RPh

Seattle, Washington, 98108, United States

Location

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

St George Hospital

Kogarah, New South Wales, 2217, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, Czech Republic, 10034, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, 100 34, Czechia

Location

Vseobecna fakultni nemocnice v Praze

Prague, 128 08, Czechia

Location

CHU de Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

Klinik fuer Onkologie und Haematologie, Medizinische Klinik IV

Aachen, 52074, Germany

Location

Klinikum Johannes-Gutenberg -Universitaet, III. Medizinische Klinik und Poliklinik

Mainz, 55131, Germany

Location

Presidio Ferrarotto - A.O.U. - PoliclinicoVittorio Emanuele

Catania, 95124, Italy

Location

Dipartimento di Medicina Diagnostica, Clinica e di Sanità Pubblica

Modena, 41124, Italy

Location

Struttura Complessa di Ematologia, Dipartimento di Oncologia ed Ematologia-

Torino, 10126, Italy

Location

Malopolskie Centrum Medyczne S.C.

Krakow, 30-510, Poland

Location

Institutul Clinic Fundeni Bucuresti, Sectia II Hematologie

Bucharest, 022328, Romania

Location

Spitalul Clinic Coltea, Clinica de Hematologie

Bucharest, 030171, Romania

Location

Spitalul Universitar de Urgenta Bucuresti, Clinica de Hematologie

Bucharest, 050098, Romania

Location

Republican Clinical Oncology Dispensary of the Ministry of Healthcare of Tatarstan Republic

Kazan', 420029, Russia

Location

GBOU VPO "First Saint-Petersburg State Medical University n.a. I.P.Pavlov"

Saint Petersburg, 197022, Russia

Location

Institute of Pediatric Hematology and Transplantology R.M.Gorbacheva

Saint Petersburg, 197022, Russia

Location

Clinical Centre of Serbia,Clinic for Hematology

Belgrade, 11000, Serbia

Location

Oncology Institute of Vojvodina

Kamenitz, 21204, Serbia

Location

Severance Hospital, Yonsei University

Seoul, 120-752, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell

Interventions

temsirolimus

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Limitations and Caveats

Overall Survival was not collected for the intended duration as planned initially, no long term follow up was conducted according to amendment in protocol. Hence overall survival results were limited

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2010
• First Posted: August 11, 2010
• Study Start: March 1, 2011
• Primary Completion: November 1, 2015
• Study Completion: June 1, 2018
• Last Updated: May 20, 2019
• Results First Posted: May 19, 2017

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share

Locations

CZ (3); KR (2); DE (2); FR (1); PL (1); AU (5); IT (3); SE (2); US (6); RU (3); RO (3)