Study Evaluating Chemotherapy in Combination With Inotuzumab Ozogamicin In Subjects With Non-Hodgkin's Lymphoma
Condition: Lymphoma, B-Cell
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Intervention: inotuzumab ozogamicin+rituximab +cyclophosphamide+vincristine+prednisone; inotuzumab ozogamicin+rituximab+gemcitabine+cisplatinum+dexamethasone
Intervention description: 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.; 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.
Intervention MeSH terms: Dexamethasone; Prednisone; Cyclophosphamide; Rituximab; Gemcitabine; Vincristine; Cisplatin; Inotuzumab Ozogamicin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Hodgkin's lymphoma

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Dose escalation cohorts: subjects with diagnosis of CD22-positive Non-Hodgkin's
             Lymphoma (NHL) who have had at least 1 prior anticancer treatment, including prior
             treatment with rituximab and chemotherapy.

          -  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:

          -  Candidate for potentially curative therapy such as stem cell transplantation.

          -  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.