- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00494780
Ofatumumab (Humax-CD20) With CHOP (Cyclophosphamide,Doxorubicin, Vincristine, Predisolone) in Follicular Lymphoma (FL) Patients (MUNIN)
June 26, 2014 updated by: GlaxoSmithKline
An Open-labeled, Randomized, Two-dose, Parallel Group Trial of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Combination With CHOP, in Patients With Previously Untreated Follicular Lymphoma (FL).
To investigate the efficacy in two dose regimens of ofatumumab in combination with CHOP (cyclophosphamide,doxorubicin, vincristine,prednisolone) in previously untreated patients with Follicular Lymphoma (FL)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Buffalo, New York, United States, 14263
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient with Follicular Lymphoma (FL)
- Confirmed diagnosis of Follicular lymphoma
- 18 years or above
- Verbal and written information about the study
Exclusion Criteria:
- No previous treatment for Follicular Lymphoma
- Clinical suspicion that the Follicular Lymphoma has transformed to aggressive lymphoma
- Several diseases such as malignancies etc.
- Screening laboratory values
- Current participation in any other interventional clinical study
- Breast feeding women or pregnant women
- Women of childbearing potential not willing to use adequate contraception
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active Comparator 1
Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks.
The first infusion will be 300mg followed by 5 infusions of 500mg
|
ofatumumab 300mg, 500mg or 1000mg should be diluted into 1000mL pyrogen free saline and administered as an IV infusion.Duration of infusion will be approximately 4 hours.Infusions should be given every 3 weeks until a total of 6 infusions has been given
Cyclophosphamide 750 mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start
Other Names:
Doxorubicin : 50mg/m2 iv for 1 day, 24-48h post-ofatumumumab infusion start
Other Names:
Vincristine : 1.4mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start
Other Names:
100mg p.o daily for 5 days, 24-48h post-ofatumumab infusion start
Other Names:
|
Active Comparator: Active Comparator 2
Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks.
The first infusion will be 300mg followed by 5 infusions of 1000mg
|
ofatumumab 300mg, 500mg or 1000mg should be diluted into 1000mL pyrogen free saline and administered as an IV infusion.Duration of infusion will be approximately 4 hours.Infusions should be given every 3 weeks until a total of 6 infusions has been given
Cyclophosphamide 750 mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start
Other Names:
Doxorubicin : 50mg/m2 iv for 1 day, 24-48h post-ofatumumumab infusion start
Other Names:
Vincristine : 1.4mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start
Other Names:
100mg p.o daily for 5 days, 24-48h post-ofatumumab infusion start
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With the Indicated Overall Best Response (OBR) at Visit 26 (3 Months After the Last Infusion of Ofatumumab)
Time Frame: Maximum of 23 months after the start of treatment
|
Based on standardized response criteria for NHL, responders included participants with CR (complete disappearance of all detectable clinical and radiographic evidence of disease), CRu (more than a 75% decrease in LN size compared to baseline), and PR (>=50% decrease in LN size and evidence of new lesions).
Non-responders included participants with stable disease (SD; <50% decrease in LN size from baseline) and progressive disease (PD; >=50% increase in LN size and evidence of new lesions).
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Maximum of 23 months after the start of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Complete Remission (CR) at Visit 26
Time Frame: Maximum of 23 months after the start of treatment
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Participants were evaluated for response by an Independent Endpoint Review Committee in accordance with the standardized response criteria for NHL.
Participants with CR were defined as those with the complete disappearance of all detectable clinical and radiographic evidence of disease.
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Maximum of 23 months after the start of treatment
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Median Percent Change From Visit 1 (Screening, Week -2) in Tumor Size at Visit 33 (24 Months After the Last Infusion of Ofatumumab)
Time Frame: Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months)
|
The tumor size for a participant was computed as the sum of product of diameters (SPD) for the indicator lesions.
Reduction in tumor size was calculated as percent change from Visit 1 until Visit 33, separately by radiologist 1 and radiologist 2. Percent change from Visit 1 (Screening, Week -2) = (value at Visit 33 minus value at Visit 1 divided by value at Visit 1) * 100.
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Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months)
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Time to New Anti-follicular Lymphoma (FL) Therapy
Time Frame: Followed up to 5 years
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Time to new FL therapy is defined as the time from randomization until the time of first administration of the new FL therapy other than ofatumumab.
Time to new FL therapy will be censored if participants are lost to follow-up.
The censoring date in such cases will be the date of the last attended visit at which the endpoint was assessed.
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Followed up to 5 years
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Progression-Free Survival (PFS)
Time Frame: Followed up to 5 years
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PFS is defined as the time from randomization until progression or death.
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Followed up to 5 years
|
Duration of Response
Time Frame: Followed up to 5 years
|
The duration of response is defined as the time from the initial response (the first visit at which response was observed) to progression or death.
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Followed up to 5 years
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Percent Change From Visit 1 (Screening) in Peripheral CD19+ and CD20+ Cell Counts at Visit 33 (24 Months After the Last Infusion of Ofatumumab)
Time Frame: Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months)
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The peripheral blood for each participant was collected and analyzed for CD19+ and CD20+ cell counts.
CD19+ and CD20+ are B-cell types which are used as an index of a participant's response to treatment.
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Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months)
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Number of Participants Who Experienced Any Adverse Event (AEs) From First Treatment to Visit 33 (24 Months After Last Infusion)
Time Frame: Up to 22 months after study start
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An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment.
A list of AEs experienced in the study with a frequency threshold of 5% can be found in the AE section.
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Up to 22 months after study start
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Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 28, and 33
Time Frame: Visits 1 (Screening), 28 (9 months after last dose), and 33 (24 months after last dose)
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HAHA are indicators of immunogenicity to ofatumumab.
Blood samples were drawn from participants at Visits 1, 28, and 33 for analysis of HAHA.
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Visits 1 (Screening), 28 (9 months after last dose), and 33 (24 months after last dose)
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Median Percent Change From Visit 1 (Screening) in Serum Complement (CH50) Levels at Visit 22
Time Frame: Visit 1 (Screening, Week -2) and Visit 22 (Week 15)
|
The peripheral blood for each participant was collected and analyzed for serum complement CH50 levels.
Cluster of Differentiation index 50 (CD50) is a human gene which is used as an index of immune response.
CD50Percent change from Visit 1 (Screening, Week -2) = (value at Visit 22 minus value at Visit 1 divided by value at Visit 1) * 100.
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Visit 1 (Screening, Week -2) and Visit 22 (Week 15)
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Number of Participants Who Had a Conversion of BCL-2 t(14;18)-Positive to Negative by Polymerase Chain Reaction (PCR) in Peripheral Blood and Bone Marrow Aspirate and Its Durability Post-therapy
Time Frame: Maximum of 6 years follow-up
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This is a genetic prognostic marker of FL response.
The former sponsor decided to not analyze these samples; therefore, no results are presented.
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Maximum of 6 years follow-up
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Cmax and Ctrough at the Sixth Infusion (Week 15, Visit 22)
Time Frame: Week 15 (Visit 22)
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Cmax is defined as the maximum concentration of drug in plasma samples.
Ctrough is defined as the trough plasma concentration (measured concentration at the end of a dosing interval [taken directly before next administration]).
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Week 15 (Visit 22)
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AUC(0-inf) and AUC(0-504) After the Sixth Infusion (Week 15, Visit 22)
Time Frame: Week 15 (Visit 22)
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AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure.
AUC(0-504) is AUC from the start of infusion to 504 hours after the start of the infusion; AUC(0-inf) is AUC from the start of infusion extrapolated to infinity.
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Week 15 (Visit 22)
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Half Life (t1/2) of Ofatumumab at the Sixth Infusion (Week 15, Visit 22)
Time Frame: Week 15 (Visit 22)
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Half life is defined as the period of time required for the amount of drug in the body to be reduced by half.
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Week 15 (Visit 22)
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CL After the Sixth Infusion (Week 15, Visit 22)
Time Frame: Week 15 (Visit 22)
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CL is the clearance of drug from plasma, which is defined as the volume of plasma from which the drug is cleared per unit time.
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Week 15 (Visit 22)
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Vss at the Sixth Infusion (Week 15, Visit 22)
Time Frame: Week 15 (Visit 22)
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Vss is defined as the volume of distribution at steady state of ofatumumab.
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Week 15 (Visit 22)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
June 29, 2007
First Submitted That Met QC Criteria
June 29, 2007
First Posted (Estimate)
July 2, 2007
Study Record Updates
Last Update Posted (Estimate)
July 11, 2014
Last Update Submitted That Met QC Criteria
June 26, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, Follicular
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Prednisolone
- Cyclophosphamide
- Ofatumumab
- Prednisone
- Doxorubicin
- Vincristine
Other Study ID Numbers
- 111775
- Hx-CD20-409 (Other Identifier: Genmab)
- The MUNIN trial
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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