Last updated: 11/03/2018 16:22:01
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 GSK Clinical Study Register is no longer maintained for this study.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.

An Open Label, Multicenter Study Investigating the Safety and Efficacy of Ofatumumab Therapy versus Physicians' Choice in Patients with Bulky Fludarabine-Refractory Chronic Lymphocytic Leukaemia (CLL)

GSK study ID
114242
See study documents
Clinicaltrials.gov ID
NCT01313689
EudraCT ID
2010-023066-52
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An Open Label, Multicenter Study Investigating the Safety and Efficacy of Ofatumumab Therapy versus Physicians' Choice in Patients with Bulky Fludarabine-Refractory Chronic Lymphocytic Leukaemia (CLL)
Trial description: The purpose of this study is to confirm the clinical benefit observed in the pivotal registration study, Hx-CD20-406. The Committee for Medicinal Products for Human Use (CHMP) required that a randomized study be conducted in CLL patients with bulky fludarabine-refractory disease as a specific obligation for grant of conditional approval for ARZERRA™ in the European Union (EU). This study will compare ofatumumab with the physicians' choice of therapy.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Progression-free Survival (PFS) as assessed by Independent Review Committee (IRC)

Timeframe: From the randomization date up to 60 months post the randomization date.

Secondary outcomes:

Overall Survival

Timeframe: From the randomization date up to 60 months post the randomization date.

Number of participants with any adverse event (AE) of special interest

Timeframe: From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy (Median follow-up approximately 28.9 months)

Progression-free Survival (PFS) as assessed by Investigator

Timeframe: From the randomization date up to 60 months post the randomization date.

Time to response as assessed by the IRC

Timeframe: From the randomization date up to 60 months post the randomization date.

Time to next anti-cancer therapy by Investigator

Timeframe: From the randomization date up to 60 months post the randomization date.

Overall response rate (ORR) as assessed by the IRC

Timeframe: From the randomization date up to 60 months post the randomization date.

Duration of response as assessed by the IRC

Timeframe: From the randomization date up to 60 months post the randomization date.

Number of participants who were positive or negative for Human Anti-Human Antibodies (HAHA) post-OFA therapy

Timeframe: From the randomization date up to 60 months post the randomization date.

Overall response rate (ORR) as assessed by the Investigator

Timeframe: From the randomization date up to 60 months post the randomization date.

Number of participants with any adverse event (AE), any serious adverse event (SAE), any fatal serious adverse event (FSAE), or deaths

Timeframe: From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy (Median follow-up approximately 28.9 months)

Mean Health Change Questionnaire (HCQ) score

Timeframe: From the randomization date up to 60 months post the randomization date.

Changes from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 item module (EORTC QLQ-CLL 16)

Timeframe: From the randomization date up to 60 months post the randomization date.

Mean Immunoglobulin (Ig) antibodies IgA, IgG, and IgM over time

Timeframe: Screening and every 3 months during treatment, every 6 months after last treatment until PD or until 30 Month Follow-up Visit

Time to progression as assessed by IRC

Timeframe: From the randomization date up to 60 months post the randomization date.

Interventions:
Drug: Ofatumumab
Drug: Physicians' Choice
Enrollment:
122
Observational study model:
Not applicable
Primary completion date:
2014-18-03
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Leukaemia, Lymphocytic, Chronic
Product
ofatumumab
Collaborators
Not applicable
Study date(s)
April 2011 to June 2018
Type
Interventional
Phase
2/3

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
  • Adults with documented diagnosis of active CLL requiring treatment
  • Bulky lymphadenopathy, defined as at least 1 lymph node >5 cm
  • Prior allogeneic stem cell transplant at any time, or autologous stem cell transplant within 6 months
  • Treatment with any unapproved drug substance or experimental therapy within 4 weeks, or currently participating in another interventional clinical study
Inclusion and exclusion criteria
Inclusion criteria:
  • Adults with documented diagnosis of active CLL requiring treatment
  • Bulky lymphadenopathy, defined as at least 1 lymph node >5 cm
  • Must be refractory to fludarabine treatment
  • Age 18 yrs or older
  • At least 2 prior therapies for CLL
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Signed written informed consent
Exclusion criteria:
  • Prior allogeneic stem cell transplant at any time, or autologous stem cell transplant within 6 months
  • Treatment with any unapproved drug substance or experimental therapy within 4 weeks, or currently participating in another interventional clinical study
  • CLL transformation, prolymphocytic leukemia, or central nervous system (CNS) involvement of CLL
  • Active autoimmune hemolytic anemia (AIHA) requiring treatment except if associated with progressive disease requiring anti-CLL treatment
  • Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment
  • Human immunodeficiency virus (HIV) positive
  • Significant concurrent, uncontrolled medical condition
  • Other past or current malignancy (with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix or breast) unless the tumor was successfully treated with curative intent at least 2 years prior to trial entry
  • Non-protocol corticosteroid usage except a maintenance dose corresponding to less than or equal to 10 mg prednisone
  • Abnormal lab values: Creatinine > 2.0 times upper normal limit (unless normal creatinine clearance), or total bilirubin > 2.0 times upper normal limit (unless due to liver involvement of CLL or due to Gilbert’s syndrome), or alanine transaminase (ALT) > 2.5 times upper normal limit (unless due to liver involvement of CLL)
  • Known or suspected hypersensitivity to ofatumumab
  • Lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception

Trial location(s)

No location data available.

Study documents

Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
No longer a GSK study
Actual primary completion date
2014-18-03
Actual study completion date
Not applicable

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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