NCT01055496 - Study Evaluating Chemotherapy in Combination With Inotuzumab Ozogamicin In Subjects With Non-Hodgkin's Lymphoma | Biotech Hunter

Enrollment

103

Participants

Timeline

Start Date

March 31, 2010

Primary Completion Date

July 31, 2013

Study Completion Date

March 31, 2014

Conditions

Lymphoma, B-Cell

Interventions

DRUG

inotuzumab ozogamicin+rituximab +cyclophosphamide+vincristine+prednisone

"Day 1:~Rituximab at 375 mg/m2 Cyclophosphamide at 375 mg/m2 (cohort 1), 550mg/m2 (cohort 2), 750 mg/m2 (cohort 3, 4) Vincristine at 1.4 mg/m2 (max 2 mg)~Day 2 Inotuzumab ozogamicin at 0.8 mg/m2 (cohort 1, 2, 3), 1.3 mg/m2 (cohort 4)~Days 1-5:~Prednisone at 40 mg/m2~Each cycle is 3 weeks, with a maximum of 6 cycles total."

DRUG

inotuzumab ozogamicin+rituximab+gemcitabine+cisplatinum+dexamethasone

"Day 1:~Rituximab at 375 mg/m2 Gemcitabine at 500 mg/m2 (cohort 1, 2b, 3b), 1000mg/m2 (cohort 2a, 3a, 4, 5) Cisplatin at 37.5 mg/m2 (cohort 1, 2a), 50mg/m2 (cohort 2b, 3a), 75mg/m2 (cohort 3b, 4, 5)~Day 2:~Inotuzumab ozogamicin at 0.8 mg/m2 (cohort 1, 2a, 2b, 3a, 3b, 4), 1.3mg/m2 (cohort 5)~Days 1-4:~Dexamethasone at 40 mg~Each cycle is 3 weeks, with a maximum of 6 cycles total."

Trial Locations (28)

3000

UZ Gasthuisberg, Leuven

9000

UZ Gent, Ghent

32608

Davis Cancer Pavillion and Shands Medical Plaza, Gainesville

Shands Cancer Hospital At The University Of Florida, Gainesville

32610

Shands Hospital at the University of Florida, Gainesville

69495

Centre Hospitalier Lyon Sud - Service d'Hematologie, Pierre-Bénite

75010

Hopital Saint-Louis -Universite Paris VII, Paris

75475

Hospital Saint-Louis - Service d'Hemato-Oncologie, Paris

98003

Northwest Medical Specialties, PLLC, Federal Way

98332

Northwest Medical Specialties, PLLC, Gig Harbor

98373

Rainier Physicians, PC, Puyallup

98405

Northwest Medical Specialties PLLC, Tacoma

98499

Northwest Medical Specialties, PLLC, Lakewood

169608

Singapore General Hospital, Singapore

19111-2497

Fox Chase Cancer Center, Philadelphia

77030-4009

The University of Texas MD Anderson Cancer Center, Houston

T6G 1Z2

Cross Cancer Institute, Edmonton

B3H 2Y9

Queen Elizabeth Health Sciences Centre, Halifax

M5G 2M9

Princess Margaret Cancer Centre, Toronto

Unknown

Prince of Wales Hospital, Hong Kong

466-8650

Nagoya Daini Red Cross Hospital, Nagoya

104-0045

National Cancer Center Hospital, Chuo-ku

135-8550

Cancer Institute Hospital, Japanese Foundation For Cancer Research, Koto-Ku

135-710

Samsung Medical Center, Seoul

SO53 2DW

Nuffield Hospital, Eastleigh

SO16 6UY

Spire Southampton Hospital, Southampton

SO16 6YD

Cancer Sciences Division, Somers Cancer Research Building, Southampton

SE1 9RT

Guy's and St Thomas' NHS Foundation Trust, London