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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
Pfizer
Study ID
NCT01055496
Phase
PHASE1
Status
Completed

Conditions

  • Lymphoma, B-Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • inotuzumab ozogamicin+rituximab +cyclophosphamide+vincristine+prednisone — DRUG
    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 — DRUG
    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.

Study Details

This is a phase 1 trial designed to evaluate safety and tolerability of chemotherapy in combination with inotuzumab ozogamicin, an investigational product, in adults with CD22-positive non-Hodgkin's lymphoma. The trial will involve two arms. In one arm, subjects will receive chemotherapy regimen R-CVP (rituximab, cyclophosphamide, vincristine and prednisone). In the other arm, subjects will receive R-GDP (rituximab, gemcitabine, cisplatinum and dexamethasone). Subjects in both arms will also receive inotuzumab ozogamicin.

Key Dates

First listed
Jan 25, 2010
Start date
Mar 31, 2010
Status verified
Jun 2019
Primary completion
Jul 31, 2013
Completion
Mar 31, 2014

Study Design

Enrollment
103 participants (actual)
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Participants Reporting Dose Limiting Toxicity (DLT) Adverse Events (AEs) for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 1 [ Time Frame: From the first dose of study medication (Study Day 1) to the completion of the first 21-day cycle. ]

Locations (10)

FacilityCityStateZIPSite coordinators
Davis Cancer Pavillion and Shands Medical PlazaGainesvilleFlorida32608-
Shands Cancer Hospital At The University Of FloridaGainesvilleFlorida32608-
Shands Hospital at the University of FloridaGainesvilleFlorida32610-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-2497-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-4009-
Northwest Medical Specialties, PLLCFederal WayWashington98003-
Northwest Medical Specialties, PLLCGig HarborWashington98332-
Northwest Medical Specialties, PLLCLakewoodWashington98499-
Rainier Physicians, PCPuyallupWashington98373-
Northwest Medical Specialties PLLCTacomaWashington98405-

Find similar trials in Gainesville, FL

By research site
Davis Cancer Pavillion and Shands Medical Plaza· Gainesville, FLShands Cancer Hospital At The University Of Florida· Gainesville, FLShands Hospital at the University of Florida· Gainesville, FLFox Chase Cancer Center· Philadelphia, PAThe University of Texas MD Anderson Cancer Center· Houston, TXNorthwest Medical Specialties, PLLC· Federal Way, WA

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