Phase 2
Completed N=61
Ofatumumab With Fludarabine and Cyclophosphamide in B-CLL Patients
Source: ClinicalTrials.gov NCT00410163 ↗Enrolled (actual)
61
Serious AEs
42.6%
Results posted
Oct 2011
Primary outcomePrimary: Number of Participants (Par.) With Complete Remission (CR), Measured From Start of Treatment Until 3 Months After Last Infusion — 10; 15 participants
Summary
To investigate the safety and efficacy of two dose regimes of ofatumumab in combination with chemotherapy in previously untreated patients with B-CLL
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants (Par.) With Complete Remission (CR), Measured From Start of Treatment Until 3 Months After Last Infusion |
10; 15 | — |
| PRIMARY Number of Participants (Par.) Who Were Classified as Responders and Non-responders |
24; 22; 10; 15; 1; 1 | — |
| SECONDARY Duration of Response |
NA; NA | — |
| SECONDARY Progression-Free Survival |
NA; 23.5 | — |
| SECONDARY Time to Next Anti-chronic Lymphocytic Leukemia (CLL) Therapy or Death |
33.4; 33.3 | — |
| SECONDARY Median Percent Change in Tumor Size From Baseline (Visit 2, Wk 0) at Visits 9, 21, 25, 29, 33, 34, 35, and 37 |
-75.00; -70.90; -100.00; -100.00; -100.00; -100.00 | — |
| SECONDARY Median Percent Change in CD5+CD19+ and CD5+CD20+ Cells in Peripheral Blood From Onset of Course 3 Throughout Follow-up (FU) Compared to Screening |
-100.00; -100.00; -100.00; -100.00; -100.00; -100.00 | — |
| SECONDARY Number of Participants Who Experienced Any Adverse Event From First Treatment (Visit 2) to Visit 43 (Month 60) |
31; 30 | — |
| SECONDARY Number of Participants With Positive Human Anti-human Anti Bodies (HAHA) at Visits 1, 21, 35, and 39 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Who Reported Myelosuppression (Anemia, Leukopenia, Neutropenia, and Thrombocytopenia) |
6; 8; 23; 22; 29; 26 | — |
| SECONDARY Percent Change From Screening (Visit 1) in Complement (CH50) Levels at Visit 9 (Week 4) |
0; 0 | — |
| SECONDARY Number of Participants Classified as Responders Having CR Who Tested Negative for Minimal Residual Disease (MRD) |
2; 6 | — |
| SECONDARY Ctrough and Cmax at the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20) |
67.5; 57.2; 201; 427; 19.9; 62.2 | — |
| SECONDARY AUC(0-inf) and AUC(0-672) After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20) |
2453; 1915; 2452; 1915; 145236; 397577 | — |
| SECONDARY t1/2 After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20) |
19.4; 18.8; 551; 746 | — |
| SECONDARY CL After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20) |
122; 157; 6.7; 6.7 | — |
| SECONDARY Vss After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20) |
3.88; 4.57; 5.15; 5.77 | — |
| SECONDARY Number of Participants With Progression or Death |
3; 7 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with active B-CLL and with an indication for treatment
- Age ≥ 18 years
- Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out
Exclusion Criteria
- Any previous treatment for B-CLL or any other treatments that can be considered active against B-CLL
- Glucocorticoid unless given in doses ≤ 10 mg /day for other indications than B-CLL (e.g. asthma)
- Known transformation of B-CLL
- Known CNS involvement of B-CLL
- Past or current malignancy, except for:
- Cervical carcinoma Stage 1B or less
- Non-invasive basal cell and squamous cell skin carcinoma
- Malignant melanoma with a complete response of a duration of > 10 years
- Other cancer diagnoses with a complete response of a duration of > 5 years
- Chronic or current infectious disease requiring systemic treatment
- Clinically significant cardiac disease
- Significant concurrent, uncontrolled medical condition
- History of significant cerebrovascular disease
- Known HIV positive
- Positive serology for hepatitis B, unless due to vaccination
- Leukapheresis, except as a safety measure before chemotherapy
- ECOG Performance Status of 3 or 4
- Patients who at the time of inclusion are not expected to be able to complete the ofatumumab-FC regimen
- Patients who have received treatment with any non-marketed drug substance or experimental therapy within 4 weeks prior to Visit 1
- Current participation in any other interventional clinical study
- Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
- Breast feeding women or women with a positive pregnancy test at Visit 1
- Women of childbearing potential not willing to use adequate contraception for up to one year after last dose of ofatumumab. Adequate contraception is defined as hormonal birth control or intrauterine device. For patients in the USA the use of a double barrier method is also considered adequate.
Data sourced from ClinicalTrials.gov (NCT00410163). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.