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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00494780
First received: June 29, 2007
Last updated: June 26, 2014
Last verified: May 2014
Results First Received: July 28, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphoma, Follicular
Interventions: Drug: Ofatumumab
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Prednisolone, Prednisone or equivalent

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
500 mg Ofatumumab + CHOP Ofatumumab was given on Day 1 and CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) on Day 3 of each 21-day cycle, with 300 milligrams (mg) in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1000 mg Ofatumumab + CHOP Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.

Participant Flow:   Overall Study
    500 mg Ofatumumab + CHOP     1000 mg Ofatumumab + CHOP  
STARTED     29     30  
COMPLETED     18     17  
NOT COMPLETED     11     13  
Adverse Event                 1                 0  
Withdrew before Dosed                 0                 1  
Progression of Study Disease                 7                 8  
New Treatment                 2                 2  
Non-compliance                 1                 0  
Residual Tumour Mass                 0                 1  
Insurance Issues                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
500 mg Ofatumumab + CHOP Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1000 mg Ofatumumab + CHOP Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
Total Total of all reporting groups

Baseline Measures
    500 mg Ofatumumab + CHOP     1000 mg Ofatumumab + CHOP     Total  
Number of Participants  
[units: participants]
  29     29     58  
Age [1]
[units: Years]
Mean ± Standard Deviation
  54.1  ± 11.4     53.7  ± 9.14     53.9  ± 10.2  
Gender [1]
[units: Participants]
     
Female     14     21     35  
Male     15     8     23  
Race/Ethnicity, Customized [1]
[units: participants]
     
White     29     27     56  
Hispanic or Latino     0     2     2  
[1]

Baseline characteristics were collected in the Full Analysis Set (FAS), comprised of all participants who were exposed to trial drug irrespective of their compliance to the planned course of treatment.

One participant was enrolled and randomized to receive 1000 mg Ofatumumab + CHOP, but withdrew prior to initiation of therapy.




  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Number of Participants With Complete Remission (CR) at Visit 26   [ Time Frame: Maximum of 23 months after the start of treatment ]

3.  Secondary:   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) ]

4.  Secondary:   Time to New Anti-follicular Lymphoma (FL) Therapy   [ Time Frame: Followed up to 5 years ]

5.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Followed up to 5 years ]

6.  Secondary:   Duration of Response   [ Time Frame: Followed up to 5 years ]

7.  Secondary:   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) ]

8.  Secondary:   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 ]

9.  Secondary:   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) ]

10.  Secondary:   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) ]

11.  Secondary:   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 ]

12.  Secondary:   Cmax and Ctrough at the Sixth Infusion (Week 15, Visit 22)   [ Time Frame: Week 15 (Visit 22) ]

13.  Secondary:   AUC(0-inf) and AUC(0-504) After the Sixth Infusion (Week 15, Visit 22)   [ Time Frame: Week 15 (Visit 22) ]

14.  Secondary:   Half Life (t1/2) of Ofatumumab at the Sixth Infusion (Week 15, Visit 22)   [ Time Frame: Week 15 (Visit 22) ]

15.  Secondary:   CL After the Sixth Infusion (Week 15, Visit 22)   [ Time Frame: Week 15 (Visit 22) ]

16.  Secondary:   Vss at the Sixth Infusion (Week 15, Visit 22)   [ Time Frame: Week 15 (Visit 22) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00494780     History of Changes
Other Study ID Numbers: 111775, Hx-CD20-409, The MUNIN trial
Study First Received: June 29, 2007
Results First Received: July 28, 2011
Last Updated: June 26, 2014
Health Authority: United States: Food and Drug Administration