Last updated: 11/03/2018 12:13:12
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
Ofatumumab (Humax-CD20) with CHOP (Cyclophosphamide,Doxorubicin, Vincristine, Predisolone) in Follicular Lymphoma (FL) patientsMUNIN
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: 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).
Trial description: 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)
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of participants with the indicated overall best response (OBR) at Visit 26 (3 months after the last infusion of Ofatumumab)
Timeframe: Maximum of 23 months after the start of treatment
Secondary outcomes:
Number of participants with complete remission (CR) at Visit 26
Timeframe: Maximum of 23 months after the start of treatment
Median percent change from Visit 1 (Screening, Week -2) in tumor size at Visit 33 (24 months after the last infusion of Ofatumumab)
Timeframe: Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months)
Time to new anti-follicular lymphoma (FL) therapy
Timeframe: Followed up to 5 years
Progression-Free Survival (PFS)
Timeframe: Followed up to 5 years
Duration of response
Timeframe: Followed up to 5 years
Percent change from Visit 1 (Screening) in peripheral CD19+ and CD20+ cell counts at Visit 33 (24 months after the last infusion of Ofatumumab)
Timeframe: Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months)
Number of participants who experienced any adverse event (AEs) from first treatment to Visit 33 (24 months after last infusion)
Timeframe: Up to 22 months after study start
Number of participants with positive human anti-human antibodies (HAHA) at Visits 1, 28, and 33
Timeframe: Visits 1 (Screening), 28 (9 months after last dose), and 33 (24 months after last dose)
Median percent change from Visit 1 (Screening) in serum complement (CH50) levels at Visit 22
Timeframe: Visit 1 (Screening, Week -2) and Visit 22 (Week 15)
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
Timeframe: Maximum of 6 years follow-up
Cmax and Ctrough at the sixth infusion (Week 15, Visit 22)
Timeframe: Week 15 (Visit 22)
AUC(0-inf) and AUC(0-504) after the sixth infusion (Week 15, Visit 22)
Timeframe: Week 15 (Visit 22)
Half life (t1/2) of ofatumumab at the sixth infusion (Week 15, Visit 22)
Timeframe: Week 15 (Visit 22)
CL after the sixth infusion (Week 15, Visit 22)
Timeframe: Week 15 (Visit 22)
Vss at the sixth infusion (Week 15, Visit 22)
Timeframe: Week 15 (Visit 22)
Interventions:
Drug: Ofatumumab
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Prednisolone, Prednisone or equivalent
Enrollment:
59
Observational study model:
Not applicable
Primary completion date:
2009-15-04
Time perspective:
Not applicable
Clinical publications:
Czuczman M, Hess G, Gadeberg O, Pedersen L, Goldstein N, Gupta I, Jewell R, Lin T, Lisby S, Strange C, Windfeld K and Viardot A. Chemoimmunotherapy with Ofatumumab in Combination with CHOP in Previously Untreated Follicular Lymphoma. [Br J Haematol]. 2012;157(4):438-445.
Czuczman M, Hess G, Gadeberg O, Pedersen L, Goldstein N, Gupta I, Jewell R, Lin T, Lisby S, Strange C, Windfeld K and Viardot A. Chemoimmunotherapy with Ofatumumab in Combination with CHOP in Previously Untreated Follicular Lymphoma. Br J Haematol. 2012;157(4):438-445
Medical condition
Lymphoma, Follicular
Product
ofatumumab
Collaborators
Not applicable
Study date(s)
June 2007 to January 2014
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Patient with Follicular Lymphoma (FL)
- Confirmed diagnosis of Follicular lymphoma
- No previous treatment for Follicular Lymphoma
- Clinical suspicion that the Follicular Lymphoma has transformed to aggressive lymphoma
Inclusion and exclusion criteria
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
Trial location(s)
Location
GSK Investigational Site
Buffalo, New York, United States, 14263
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
No longer a GSK study
Actual primary completion date
2009-15-04
Actual study completion date
2014-09-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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Access to clinical trial data by researchers
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