Study Evaluating Chemotherapy in Combination With Inotuzumab Ozogamicin In Subjects With Non-Hodgkin's Lymphoma
NCT ID: NCT01055496
Last Updated: 2019-08-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
103 participants
INTERVENTIONAL
2010-03-31
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
TREATMENT
NONE
Study Groups
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Arm 1 (R-CVP)
Subjects in arm 1 will be enrolled in dose escalation cohorts that will initially evaluate an escalating dose of cyclophosphamide in combination with set doses of inotuzumab ozogamicin, vincristine, prednisone, and rituximab.
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.
Arm 2 (R-GDP)
Subjects in arm 2 will be enrolled in dose escalation cohorts that will initially evaluate escalating doses of gemcitabine and/or cisplatinum in combination with set doses of inotuzumab ozogamicin, dexamethasone, and rituximab.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Expanded maximum tolerated dose (MTD) confirmation and preliminary efficacy cohorts: subjects with diagnosis of CD22-positive NHL who have had at least 1 prior anticancer treatment, including prior treatment with rituximab and chemotherapy or newly diagnosed subjects who are not candidates for anthracycline-based therapy.
* At least 1 measurable disease lesion that is \> 1 cm in the longest transverse diameter, with a product of the diameters \> 2.25 cm2 by CT or magnetic resonance imaging (MRI).
Exclusion Criteria
* Prior allogeneic hematopoietic stem cell transplantation (HSCT).
* Prior autologous transplantation, radioimmunotherapy, or other anti CD22 immunotherapy \<= 6 months before the first dose of investigational product.
* More than 3 previous combination chemotherapy (2 or more cytotoxics) anticancer regimens.
18 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Davis Cancer Pavillion and Shands Medical Plaza
Gainesville, Florida, United States
Shands Cancer Hospital At The University Of Florida
Gainesville, Florida, United States
Shands Hospital at the University of Florida
Gainesville, Florida, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Northwest Medical Specialties, PLLC
Federal Way, Washington, United States
Northwest Medical Specialties, PLLC
Gig Harbor, Washington, United States
Northwest Medical Specialties, PLLC
Lakewood, Washington, United States
Rainier Physicians, PC
Puyallup, Washington, United States
Northwest Medical Specialties PLLC
Tacoma, Washington, United States
UZ Gent
Ghent, , Belgium
UZ Gasthuisberg
Leuven, , Belgium
Cross Cancer Institute
Edmonton, Alberta, Canada
Queen Elizabeth Health Sciences Centre
Halifax, Nova Scotia, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Hopital Saint-Louis -Universite Paris VII
Paris, , France
Hospital Saint-Louis - Service d'Hemato-Oncologie
Paris, , France
Centre Hospitalier Lyon Sud - Service d'Hematologie
Pierre-Bénite, , France
Prince of Wales Hospital
Hong Kong, , Hong Kong
Nagoya Daini Red Cross Hospital
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Cancer Institute Hospital, Japanese Foundation For Cancer Research
Koto-Ku, Tokyo, Japan
Singapore General Hospital
Singapore, , Singapore
Samsung Medical Center
Seoul, , South Korea
Nuffield Hospital
Eastleigh, Hants, United Kingdom
Spire Southampton Hospital
Southampton, Hants, United Kingdom
Cancer Sciences Division, Somers Cancer Research Building
Southampton, Hants, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
Countries
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References
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Sangha R, Davies A, Dang NH, Ogura M, MacDonald DA, Ananthakrishnan R, Paccagnella ML, Vandendries E, Boni J, Goh YT. Phase 1 study of inotuzumab ozogamicin combined with R-GDP for the treatment of patients with relapsed/refractory CD22+ B-cell non-Hodgkin lymphoma. J Drug Assess. 2017 Aug 16;6(1):10-17. doi: 10.1080/21556660.2017.1315336. eCollection 2017.
Ogura M, Tobinai K, Hatake K, Davies A, Crump M, Ananthakrishnan R, Ishibashi T, Paccagnella ML, Boni J, Vandendries E, MacDonald D. Phase I Study of Inotuzumab Ozogamicin Combined with R-CVP for Relapsed/Refractory CD22+ B-cell Non-Hodgkin Lymphoma. Clin Cancer Res. 2016 Oct 1;22(19):4807-4816. doi: 10.1158/1078-0432.CCR-15-2488. Epub 2016 May 6.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B1931003
Identifier Type: OTHER
Identifier Source: secondary_id
2009-015497-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3129K2-1105
Identifier Type: -
Identifier Source: org_study_id
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