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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 has been terminated.
(See termination reason in detailed description.)
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00562965
First received: November 21, 2007
Last updated: December 22, 2012
Last verified: December 2012
  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
Drug: vincristine
Drug: prednisone/prednisolone
Drug: mitoxantrone
Drug: fludarabine
Drug: dexamethasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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 Pfizer:

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: 4 years ] [ 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: 4 years ] [ Designated as safety issue: Yes ]
  • To evaluate the efficacy of inotuzumab ozogamicin in combination with rituximab using the following endpoints and analyses: Overall Response Rate and Overall Survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • QT assessment [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Enrollment: 29
Study Start Date: November 2007
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Subjects will receive rituximab intravenously at a dose level of 375 mg/m² on day 1 of each cycle followed by inotuzumab ozogamicin administered intravenously at a dose level of 1.8 mg/m2 on day 2. The sequence will be repeated every 28 days.
Drug: inotuzumab ozogamicin
IV administration, 1.8mg/m² on day 2 of each cycle every 28 days, for up to 8 cycles.
Drug: rituximab
IV administration, 375 mg/m² on day 1 of each cycle every 28 days, for up to 8 cycles.
Active Comparator: B
Subjects will receive the investigator's choice from the following rituximab-containing regimens: R-CVP or R-FND. The investigator's choice of therapy will be administered every 21 days. Dosing for R-CVP will be intravenous rituximab at a dose of 375 mg/m2 on day 1, intravenous cyclophosphamide at a dose of 750 mg/m2 on day 1, intravenous vincristine at a dose of 1.4 mg/m2 (not to exceed 2 mg) on day 1, and oral prednisone/prednisolone at a dose of 40 mg/m2 on days 1 through 5. Dosing for R-FND will be as follows: rituximab 375 mg/m2 intravenous on day 1, mitoxantrone 10 mg/m2 intravenous on day 2, fludarabine 25 mg/m2 intravenous on days 2 through 4 and oral dexamethasone 20 mg/day on days 1-5.
Drug: rituximab
intravenous rituximab at a dose of 375 mg/m2 on day 1
Drug: cyclophosphamide
intravenous cyclophosphamide at a dose of 750 mg/m2 on day 1
Drug: vincristine
intravenous vincristine at a dose of 1.4 mg/m2 (not to exceed 2 mg) on day 1
Drug: prednisone/prednisolone
oral prednisone/prednisolone at a dose of 40 mg/m2 on days 1 through 5
Drug: mitoxantrone
mitoxantrone 10 mg/m2 intravenous on day 2
Drug: fludarabine
fludarabine 25 mg/m2 intravenous on days 2 through 4
Drug: dexamethasone
oral dexamethasone 20 mg/day on days 1-5

Detailed Description:

On January 14th 2009, enrollment in the study was discontinued because of poor enrollment and because it was unlikely that the study would meet the estimated enrollment of approximately 978 subjects. The decision was not prompted by the identification of any safety signals in this or other studies. Active treatment and follow-up of the already enrolled subjects was continued. On July, 22th 2010 , the study was amended to shorten the long-term follow-up to one year after active treatment.

  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 grade 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
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: NCT00562965

  Show 38 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: NCT00562965     History of Changes
Other Study ID Numbers: 3129K4-3301, B1931006
Study First Received: November 21, 2007
Last Updated: December 22, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
BB 1101
Cyclophosphamide
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Fludarabine
Fludarabine phosphate
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Mitoxantrone
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Prednisone
Rituximab
Vincristine
Alkylating Agents
Analgesics
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on November 20, 2014