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

This study has been completed.
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01055496
First received: January 21, 2010
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Lymphoma, B-Cell
Drug: inotuzumab ozogamicin+rituximab +cyclophosphamide+vincristine+prednisone
Drug: inotuzumab ozogamicin+rituximab+gemcitabine+cisplatinum+dexamethasone
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Phase 1 Study Of R-CVP Or R-GDP In Combination With Inotuzumab Ozogamicin In Subjects With CD22-Positive Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To determine the tolerability, the initial safety profile, as evaluated by an analysis of laboratory results and adverse event (AE) reporting. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Determination of MTD or recommended dose of the immunochemotherapeutic regimens R-CVP or R-GDP given in combination with inotuzumab ozogamicin in subjects with CD22-positive NHL. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To obtain preliminary information on the antitumor activity of R-CVP or R-GDP in combination with inotuzumab ozogamicin as measured by ORR, progression-free survival, and overall survival data in MTD confirmation/expanded efficacy cohorts [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To evaluate PK of 0.8 mg/m2 of inotuzumab ozogamicin when combined with R CVP or with R-GDP [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To develop a molecular predictor of response to inotuzumab ozogamicin plus R-CVP or R-GDP. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 104
Study Start Date: March 2010
Study Completion Date: March 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

Other Name: CMC-544
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.
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.

Other Name: CMC-544

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055496

  Show 26 Study Locations
Sponsors and Collaborators
Pfizer
UCB Pharma
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01055496     History of Changes
Other Study ID Numbers: 3129K2-1105, B1931003
Study First Received: January 21, 2010
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Non-Hodgkin's lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
BB 1101
Cisplatin
Cyclophosphamide
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Gemcitabine
Prednisone
Rituximab
Vincristine
Alkylating Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 20, 2014