Study Evaluating Inotuzumab Ozogamicin (CMC-544) In Indolent Non-Hodgkins Lymphoma
This study is ongoing, but not recruiting participants.
Sponsor:
Pfizer
Collaborator:
UCB, Inc.
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00868608
First received: March 24, 2009
Last updated: May 2, 2013
Last verified: May 2013
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Purpose
The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin (CMC-544) in subjects with indolent Non-Hodgkins lymphoma (NHL) that is refractory or has relapsed after multiple therapies including rituximab or radioimmunotherapy. The investigational drug will be given to subjects with indolent NHL by intravenous infusion at a dose of 1.8 mg/m2, every 4 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: Inotuzumab Ozogamicin (CMC-544) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Study Of Inotuzumab Ozogamicin (CMC-544) In Subjects With Indolent Non-Hodgkin's Lymphoma (NHL) That Is Refractory To Or Has Relapsed After Rituximab And Chemotherapy Or Radioimmunotherapy |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Response rate of subjects with indolent NHL treated with inotuzumab ozogamicin as measured by CT/MRI scans at regular intervals. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Safety and tolerability of inotuzumab ozogamicin in the treatment of subjects with indolent NHL. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Further assess the response rate of subjects with indolent NHL treated with inotuzumab ozogamicin by evaluating the complete response (CR) rate, duration of response (DR), progression free survival (PFS) and overall survival (OS). [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Determine the ORR, CR, DR, PFS and OS in subjects with follicular NHL treated with inotuzumab ozogamicin. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Evaluate the population pharmacokinetic (PK) profile of inotuzumab ozogamicin. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Evaluate the concentration-effect relationship of cardiac QT measures. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 83 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | July 2013 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: inotuzumab ozogamicin
inotuzumab ozogamicin
|
Drug: Inotuzumab Ozogamicin (CMC-544)
Administered intravenously at 1.8 mg/m2 every 4 weeks for a planned 4 - 8 cycles
Other Name: inotuzumab ozogamicin
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone, or small lymphocytic lymphoma) that has progressed after 2 or more prior systemic therapies.
- Previous anticancer treatment given must have contained rituximab and chemotherapy, or anti CD20 Radio Immuno Therapy. Subjects must have exhibited no response or have progressed within 6 months from the completion of the most recent rituximab or rituximab containing therapy or within 12 months of the completion of Radio Immuno Therapy.
- Measurable disease with adequate bone marrow function, renal and hepatic function
Exclusion Criteria:
- History of, or suggestive of, veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS) or history of chronic liver disease (eg, cirrhosis) or suspected alcohol abuse.
- Prior allogeneic hematopoietic stem cell transplant (HSCT).
- Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3b follicular lymphoma.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00868608
Show 28 Study Locations
Show 28 Study LocationsSponsors and Collaborators
Pfizer
UCB, Inc.
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00868608 History of Changes |
| Other Study ID Numbers: | 3129K7-2001, B1931007 |
| Study First Received: | March 24, 2009 |
| Last Updated: | May 2, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Refractory Indolent NHL lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013