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 overview
Progression-free Survival (PFS) as assessed by Independent Review Committee (IRC)
Timeframe: From the randomization date up to 60 months post the randomization date.
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.
Participation criteria
- 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
- 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
- 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)
This study does not involve prospective enrollment of participants.
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
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.