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Study Comparing Inotuzumab Ozogamicin in Combination With Rituximab Versus Defined Investigator's Choice in Follicular Non-Hodgkin's Lymphoma (NHL)
This study is ongoing, but not recruiting participants.
First Received: November 21, 2007   Last Updated: August 5, 2009   History of Changes
Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00562965
  Purpose

This protocol is designed to assess the efficacy and safety of inotuzumab ozogamicin given with rituximab compared to a defined investigator's choice therapy. Subjects will be randomized to one of these two arms of the study.


Condition Intervention Phase
Lymphoma, Follicular
Drug: inotuzumab ozogamicin
Drug: rituximab
Drug: cyclophosphamide, vincristine and prednisone/prednisolone (R-CVP)
Drug: fludarabine, Novantrone (mitoxantrone) and dexamethasone (R-FND)
Phase III

Study Type: Interventional
Study Design: Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: An Open-Label, Randomized, Phase 3 Study of Inotuzumab Ozogamicin (CMC-544) Administered in Combination With Rituximab Compared to a Defined Investigator's Choice Therapy in Subjects With Relapsed or Refractory, CD22-Positive, Follicular B-Cell Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Wyeth:

Primary Outcome Measures:
  • To assess efficacy as measured by progression free survival (PFS), with a goal of demonstrating the superiority of inotuzumab ozogamicin when administered in combination with rituximab, compared with an active comparator arm. [ Time Frame: life of trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety and tolerability of inotuzumab ozogamicin in combination with rituximab. To assess the population pharmacokinetics (PK) of inotuzumab ozogamicin in combination with rituximab, and to evaluate factors affecting drug metabolism. [ Time Frame: life of trial ] [ Designated as safety issue: No ]

Estimated Enrollment: 978
Study Start Date: November 2007
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental Drug: inotuzumab ozogamicin Drug: rituximab
B: Active Comparator Drug: rituximab Drug: cyclophosphamide, vincristine and prednisone/prednisolone (R-CVP) Drug: fludarabine, Novantrone (mitoxantrone) and dexamethasone (R-FND)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a diagnosis of CD20 and CD22-positive, follicular lymphoma, who have received 1 or 2 prior regimens, at least 1 of which should have contained administration of rituximab (either as a single agent or in combination).
  • Age 18 years or older,
  • ECOG performance status ≤ 2,
  • ANC ≥ 1.5 x 10^9/L (1500/mL) and platelets ≥ 75 x 10^9/L (75,000/mL), serum creatinine ≤ 1.5 x ULN and urine protein to creatinine ratio of ≤ 0.5, total bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 2.5 x ULN.
  • At least 1 measurable disease lesion that is ≥ 1.5 cm x 1.5 cm by CT or MRI, in an area of no prior radiation therapy, or documented progression in an area that was previously irradiated.

Exclusion Criteria:

  • Subjects with clinical evidence of transformation to a more aggressive subtype of lymphoma or stage 3B follicular lymphoma.
  • Subjects whose disease is rituximab refractory, meaning that they did not have a CR or PR, or that they experienced disease progression within 6 months from the initiation of the rituximab or rituximab containing treatment regimen administered immediately preceding study enrollment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00562965

  Show 111 Study Locations
Sponsors and Collaborators
Wyeth
Investigators
Study Director: Medical Monitor Wyeth
  More Information

No publications provided

Responsible Party: Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers: 3129K4-3301
Study First Received: November 21, 2007
Last Updated: August 5, 2009
ClinicalTrials.gov Identifier: NCT00562965     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Anti-Inflammatory Agents
Dexamethasone
Prednisone
Immunologic Factors
Methylprednisolone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Lymphoma, Follicular
Antiemetics
Prednisolone acetate
Cyclophosphamide
Hormones
Follicular Lymphoma
Antibodies, Monoclonal
Lymphoma, Small Cleaved-cell, Diffuse
Lymphoma, B-Cell
Analgesics
Alkylating Agents
Lymphoma
Dexamethasone acetate
Immunoglobulins
Methylprednisolone Hemisuccinate
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Rituximab
Methylprednisolone acetate
Vincristine
Fludarabine monophosphate
Glucocorticoids
Immunosuppressive Agents

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Dexamethasone
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Lymphoma, Follicular
Antiemetics
Cyclophosphamide
Hormones
Antibodies, Monoclonal
Sensory System Agents
Therapeutic Uses
Analgesics
Lymphoma
Alkylating Agents
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Rituximab
Gastrointestinal Agents
Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Autonomic Agents
Prednisolone

ClinicalTrials.gov processed this record on September 10, 2009