Clinical trial NCT00494780: Ofatumumab (Humax-CD20) With CHOP (Cyclophosphamide,Doxorubicin, Vincristine, Predisolone) in Follicular Lymphoma (FL) Patients
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, Follicular
Keywords: CHOP (cyclophosphamide,doxorubicin,vincristine,prednisolone)
ofatumumab
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-07-02
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)


Eligibility 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

Primary outcomes:
measure: 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:
measure: Number of Participants With Complete Remission (CR) at Visit 26
timeFrame: Maximum of 23 months after the start of treatment
measure: 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)
measure: Time to New Anti-follicular Lymphoma (FL) Therapy
timeFrame: Followed up to 5 years
measure: Progression-Free Survival (PFS)
timeFrame: Followed up to 5 years
measure: Duration of Response
timeFrame: Followed up to 5 years
measure: 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)
measure: 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
measure: 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)
measure: 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)
measure: 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
measure: Cmax and Ctrough at the Sixth Infusion (Week 15, Visit 22)
timeFrame: Week 15 (Visit 22)
measure: AUC(0-inf) and AUC(0-504) After the Sixth Infusion (Week 15, Visit 22)
timeFrame: Week 15 (Visit 22)
measure: Half Life (t1/2) of Ofatumumab at the Sixth Infusion (Week 15, Visit 22)
timeFrame: Week 15 (Visit 22)
measure: CL After the Sixth Infusion (Week 15, Visit 22)
timeFrame: Week 15 (Visit 22)
measure: Vss at the Sixth Infusion (Week 15, Visit 22)
timeFrame: Week 15 (Visit 22)
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: GSK Investigational Site
state: New York
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.