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Ofatumumab (Humax-CD20) With CHOP (Cyclophosphamide,Doxorubicin, Vincristine, Predisolone) in Follicular Lymphoma (FL) Patients (MUNIN)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00494780
First Posted: July 2, 2007
Last Update Posted: July 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
June 29, 2007
July 2, 2007
July 28, 2011
August 26, 2011
July 11, 2014
June 2007
April 2009   (Final data collection date for primary outcome measure)
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).
Not Provided
Complete list of historical versions of study NCT00494780 on ClinicalTrials.gov Archive Site
  • Number of Participants With Complete Remission (CR) at Visit 26 [ Time Frame: Maximum of 23 months after the start of treatment ]
    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.
  • 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.
  • Time to New Anti-follicular Lymphoma (FL) Therapy [ Time Frame: Followed up to 5 years ]
    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.
  • Progression-Free Survival (PFS) [ Time Frame: Followed up to 5 years ]
    PFS is defined as the time from randomization until progression or death.
  • 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.
  • 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) ]
    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.
  • 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 ]
    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.
  • 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) ]
    HAHA are indicators of immunogenicity to ofatumumab. Blood samples were drawn from participants at Visits 1, 28, and 33 for analysis of HAHA.
  • 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.
  • 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 ]
    This is a genetic prognostic marker of FL response. The former sponsor decided to not analyze these samples; therefore, no results are presented.
  • Cmax and Ctrough at the Sixth Infusion (Week 15, Visit 22) [ Time Frame: Week 15 (Visit 22) ]
    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]).
  • AUC(0-inf) and AUC(0-504) After the Sixth Infusion (Week 15, Visit 22) [ Time Frame: Week 15 (Visit 22) ]
    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.
  • Half Life (t1/2) of Ofatumumab at the Sixth Infusion (Week 15, Visit 22) [ Time Frame: Week 15 (Visit 22) ]
    Half life is defined as the period of time required for the amount of drug in the body to be reduced by half.
  • CL After the Sixth Infusion (Week 15, Visit 22) [ Time Frame: Week 15 (Visit 22) ]
    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.
  • Vss at the Sixth Infusion (Week 15, Visit 22) [ Time Frame: Week 15 (Visit 22) ]
    Vss is defined as the volume of distribution at steady state of ofatumumab.
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Not Provided
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Ofatumumab (Humax-CD20) With CHOP (Cyclophosphamide,Doxorubicin, Vincristine, Predisolone) in Follicular Lymphoma (FL) Patients
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)
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lymphoma, Follicular
  • Drug: Ofatumumab
    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
  • Drug: Cyclophosphamide
    Cyclophosphamide 750 mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start
    Other Name: CHOP
  • Drug: Doxorubicin
    Doxorubicin : 50mg/m2 iv for 1 day, 24-48h post-ofatumumumab infusion start
    Other Name: CHOP
  • Drug: Vincristine
    Vincristine : 1.4mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start
    Other Name: CHOP
  • Drug: Prednisolone, Prednisone or equivalent
    100mg p.o daily for 5 days, 24-48h post-ofatumumab infusion start
    Other Name: CHOP
  • 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
    Interventions:
    • Drug: Ofatumumab
    • Drug: Cyclophosphamide
    • Drug: Doxorubicin
    • Drug: Vincristine
    • Drug: Prednisolone, Prednisone or equivalent
  • 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
    Interventions:
    • Drug: Ofatumumab
    • Drug: Cyclophosphamide
    • Drug: Doxorubicin
    • Drug: Vincristine
    • Drug: Prednisolone, Prednisone or equivalent
Czuczman MS, Hess G, Gadeberg OV, Pedersen LM, Goldstein N, Gupta I, Jewell RC, Lin TS, Lisby S, Strange C, Windfeld K, Viardot A; 409 Study Investigators. Chemoimmunotherapy with ofatumumab in combination with CHOP in previously untreated follicular lymphoma. Br J Haematol. 2012 May;157(4):438-45. doi: 10.1111/j.1365-2141.2012.09086.x. Epub 2012 Mar 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
September 2010
April 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
Czech Republic,   Denmark,   Germany,   Sweden,   United Kingdom
 
NCT00494780
111775
Hx-CD20-409 ( Other Identifier: Genmab )
The MUNIN trial
Yes
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP