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

PHASE3CompletedINTERVENTIONAL
Enrollment

169

Participants

Timeline

Start Date

May 31, 2005

Primary Completion Date

August 31, 2007

Study Completion Date

January 31, 2011

Conditions
Lymphoma
Interventions
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"

Trial Locations (73)

3000

Pfizer Investigational Site, East Melbourne

Pfizer Investigational Site, Leuven

5000

Pfizer Investigational Site, Córdoba

5001

Pfizer Investigational Site, Aarau

8000

Pfizer Investigational Site, Bruges

9000

Pfizer Investigational Site, Ghent

Pfizer Investigational Site, Ghent

14263

Pfizer Investigational Site, Buffalo

19013

Pfizer Investigational Site, Upland

20007

Pfizer Investigational Site, Washington D.C.

20132

Pfizer Investigational Site, Milan

28006

Pfizer Investigational Site, Madrid

28041

Pfizer Investigational Site, Madrid

31008

Pfizer Investigational Site, Pamplona

33428

Pfizer Investigational Site, Boca Raton

40128

Pfizer Investigational Site, Bologna

55131

Pfizer Investigational Site, Mainz

60612

Pfizer Investigational Site, Chicago

67098

Pfizer Investigational Site, Strasbourg

69008

Pfizer Investigational Site, Lyon

69120

Pfizer Investigational Site, Heidelberg

69495

Pfizer Investigational Site, Pierre-Bénite

72205

Pfizer Investigational Site, Little Rock

75475

Pfizer Investigational Site, Paris

75747

Pfizer Investigational Site, Paris

76051

Pfizer Investigational Site, Grapevine

76508

Pfizer Investigational Site, Temple

78705

Pfizer Investigational Site, Austin

89070

Pfizer Investigational Site, Ulm

89081

Pfizer Investigational Site, Ulm

92708

Pfizer Investigational Site, Fountain Valley

94805

Pfizer Investigational Site, Villejuif

95124

Pfizer Investigational Site, Catania

96813

Pfizer Investigational Site, Honolulu

97227

Pfizer Investigational Site, Portland

98101

Pfizer Investigational Site, Seattle

100021

Pfizer Investigational Site, Beijing

100036

Pfizer Investigational Site, Beijing

200032

Pfizer Investigational Site, Shanghai

200433

Pfizer Investigational Site, Shanghai

2000025

Pfizer Investigational Site, Shanghai

90024-2828

Pfizer Investigational Site, Los Angeles

06776

Pfizer Investigational Site, New Milford

07960

Pfizer Investigational Site, Morristown

10029-6574

Pfizer Investigational Site, New York

14642-8668

Pfizer Investigational Site, Rochester

77030-4009

Pfizer Investigational Site, Houston

C1406FWZ

Pfizer Investigational Site, Buenos Aires

C1405BWU

Pfizer Investigational Site, Buenos Aires

A-1090

Pfizer Investigational Site, Vienna

01221-010

Pfizer Investigational Site, Vila Buarque

90610-000

Pfizer Investigational Site, Porto Alegre - RS

T6G 1Z2

Pfizer Investigational Site, Edmonton

V6Z 1Y6

Pfizer Investigational Site, Vancouver

N6A 4L5

Pfizer Investigational Site, London

K1H 8L6

Pfizer Investigational Site, Ottawa

M5G 2C4

Pfizer Investigational Site, Toronto

J4V 2H1

Pfizer Investigational Site, Greenfield Park

H1T2M4

Pfizer Investigational Site, Montreal

H4J 1C5

Pfizer Investigational Site, Montreal

Unknown

Pfizer Investigational Site, Providencia

00161

Pfizer Investigational Site, Roma

3015 GD

Pfizer Investigational Site, Rotterdam

20-081

Pfizer Investigational Site, Lublin

02-781

Pfizer Investigational Site, Warsaw

08035

Pfizer Investigational Site, Barcelona

08907

Pfizer Investigational Site, L'Hospitalet de Llobregat

221 85

Pfizer Investigational Site, Lund

751 85

Pfizer Investigational Site, Uppsala

PL6 8DH

Pfizer Investigational Site, Plymouth

SO16 6YD

Pfizer Investigational Site, Southampton

SW17 0QT

Pfizer Investigational Site, Tooting

SM2 5PT

Pfizer Investigational Site, Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY