Efficacy and Safety of Ofatumumab Retreatment and Maintenance Treatment in Patients With B-cell Chronic Lymphocytic Leukemia (CLL)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00802737
• Date of registration: 04/12/2008
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Efficacy and Safety of Ofatumumab Retreatment and Maintenance Treatment in Patients With B-cell Chronic Lymphocytic Leukemia (CLL)
• Scientific title: A Single-arm, International, Multi-center Trial Investigating the Efficacy and Safety of Ofatumumab Retreatment and Maintenance in CLL Patients Who Progressed Following Response or Stable Disease After Ofatumumab Treatment in Hx-CD20-406
• Date of first enrolment: January 2009
• Target sample size: 29
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00802737
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

Czech Republic, France, Germany, Italy, Poland, Sweden, United Kingdom, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- Has responded to ofatumumab treatment (CR, nPR, PR) or has had SD at least up to and
including visit number 14 (24 weeks after first infusion) in the Hx-CD20-406 trial.

- Has disease progression after visit number 14 (24 weeks after first infusion) in the
Hx CD20 406 trial.

- Received at least eight ofatumumab infusions.

- Has active CLL with an indication for treatment.

- Has Eastern Cooperative Oncology Group (ECOG) performance status grade 0, 1 or 2.

- Provides signed informed consent, following receipt of verbal and written information
about the trial, before any trial related activity is carried out.

- If previously treated in GEN416 (this trial), the patient must have achieved CR with
subsequent disease progression 24 weeks or later after the first infusion in the
GEN416 trial.

Exclusion Criteria:

- The disease has transformed to more aggressive B-cell malignancies (e.g. diffuse large
B-cell lymphoma, Richter's syndrome or prolymphocytic leukemia).

- Has a suspected treatment requiring malignancy other than CLL.

- Has received treatment other than ofatumumab within two weeks prior to visit 2.

- Has clinically significant cardiac disease including unstable angina, acute myocardial
infarction within six months from visit 1, congestive heart failure (NYHA III IV), and
arrhythmia requiring therapy, with the exception of clinically non-significant extra
systoles or minor conduction abnormalities.

- Has significant concurrent, uncontrolled medical condition including, but not limited
to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary,
neurological, cerebral or psychiatric disease.

- Has a history of significant cerebrovascular disease.

- Is known HIV positive.

- Has positive serology for hepatitis B, defined as a positive test for HBsAg and/or
positive tests for both anti-HBs and anti-HBc.

- Has known or suspected hypersensitivity to components of the IMP.

- Has received treatment with any non-marketed drug substance or experimental therapy
other than ofatumumab within four weeks prior to visit 2.

- Currently participates in any other interventional clinical trial other than
Hx-CD20-406.

- Known or suspected to not being able to comply with a trial protocol (e.g. due to
alcoholism, drug dependency or psychiatric disorder).

- Is breast feeding (women only).

- Has a positive pregnancy test at screening (women only).

- Is not willing to use adequate contraception during the trial and one year after last
dose of ofatumumab (women only). Adequate contraception is defined as hormonal birth
control or intrauterine device. For patients in the US the use of double barrier
method is considered adequate.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Leukaemia, Lymphocytic, Chronic

Intervention(s)

Drug: Ofatumumab

Primary Outcome(s)

Number of Participants (Par.) Classified as Responders (Rs) and Non-responders (NRs) for Objective Response in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines [Time Frame: Start of treatment (Week 0/Visit 2) until Week 52]

Secondary Outcome(s)

Number of Participants With Infections Requiring Hospitalization or Intravenous Antibiotics [Time Frame: From the first infusion (Visit 2/Week 0) until the last visit of the Extended Follow-up Phase (up to Study Month 26 [visit 34])]

Overall Survival (OS) [Time Frame: Time from start of study treatment (Week 0 of Visit 2) until date of death or time that participant was no longer followed (median of 18.0 months)]

Number of Participants With the Indicated Major Infections [Time Frame: From the first infusion (Visit 2/Week 0) until the last visit of the Extended Follow-up Phase (up to Study Month 26 [visit 34])]

Time to Next Chronic Lymphocytic Leukemia (CLL) Treatment [Time Frame: Time from start of study treatment (Week 0 of Visit 2) until the time of first administration of a CLL treatment other than ofatumumab (average of 14.8 study months)]

Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) at Month 24 [Time Frame: Baseline (Visit 2) and Month 24]

Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) at Month 12 [Time Frame: Baseline (Visit 2) and Month 12]

Number of Participants With Negative and Positive Human Anti-human Antibody (HAHA) Results at the Time of Screening and Post Ofatumumab [Time Frame: Screening and post ofatumumab (up to Study Month 32)]

Number of Participants Who Experienced Any Adverse Event [Time Frame: From the first infusion (Visit 2/Week 0) until the last visit of the Extended Follow-up Phase (up to Study Month 26 [visit 34])]

Progression-Free Survival (PFS) [Time Frame: Start of treatment (Week 0 of Visit 2) until progression or death (average of 14.1 study months)]

Cmax and Ctrough at Visit 2 (Week 0) and at Visit 14 (Month 4) [Time Frame: Visit 2 (Week 0) and Visit 14 (Month 4)]

Duration of Response [Time Frame: From the time of the initial response until progression or death (average of 14.1 study months)]

Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) at Month 4 [Time Frame: Baseline (Visit 2) and Month 4]

Secondary ID(s)

111827

GEN416

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Genmab

Results

• Results available: Yes
• Date Posted: 26/06/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00802737