Phase 3
Completed N=365
Ofatumumab Added to Fludarabine-Cyclophosphamide vs Fludarabine-Cyclophosphamide Combination in Relapsed Subjects With Chronic Lymphocytic Leukemia
Source: ClinicalTrials.gov NCT00824265 ↗Enrolled (actual)
365
Serious AEs
54.0%
Results posted
Jul 2016
Primary outcomePrimary: Progression-free Survival (PFS), as Assessed by the Independent Review Committee (IRC) — 28.94; 18.83 Months — p=0.0032
◆ Published Evidence
Established
58citations · ~6 / year
Ofatumumab plus fludarabine and cyclophosphamide in relapsed chronic lymphocytic leukemia: results from the COMPLEMENT 2 trial.
Summary
The purpose of this study was to evaluate the safety and efficacy of ofatumumab added to fludarabine-cyclophosphamide in patients with relapsed Chronic Lymphocytic Leukemia (CLL).
Linked Publications (3)
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Ofatumumab plus fludarabine and cyclophosphamide in relapsed chronic lymphocytic leukemia: results from the COMPLEMENT 2 trial.
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Health-related quality of life and patient-reported outcomes of ofatumumab plus fludarabine and cyclophosphamide versus fludarabine and cyclophosphamide in the COMPLEMENT 2 trial of patients with relapsed CLL.
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Assessment of the effect of ofatumumab on cardiac repolarization.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS), as Assessed by the Independent Review Committee (IRC) |
28.94; 18.83 | 0.0032 sig |
| SECONDARY Overall Survival (OS) |
62.65; 46.23 | 0.1427 |
| SECONDARY Time to Response, as Assessed by the IRC |
0.99; 0.99 | 0.4490 |
| SECONDARY Duration of Response (DOR), as Assessed by the IRC |
29.63; 24.90 | 0.0878 |
| SECONDARY Time to Progression, as Assessed by the IRC |
42.12; 26.78 | 0.0036 sig |
| SECONDARY Time to Next Therapy |
29.68; 21.03; 52.96; 40.08 | 0.1143 |
| SECONDARY Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status |
15; 13; 16; 13; 19; 13 | — |
| SECONDARY Number of Participants With no B-Symptoms or at Least One B-symptoms Over the Time |
63; 59; 120; 121; 64; 68 | — |
| SECONDARY Percentage of Participants With the Best Overall Response (OR), as Assessed by the IRC |
27; 7; 2; 1; 0; 0 | 0.0003 sig |
| SECONDARY Percentage of Participants With the Best OR, as Assessed by the Investigator |
45; 24; 12; 4; 2; 8 | 0.0166 sig |
| SECONDARY Number of Participants Who Were Negative for Minimal Residual Disease (MRD) Assessed by IRC |
0; 0; 0; 21; 7; 25 | — |
| SECONDARY Number of Participants Who Were Negative for MRD Assessed by Investigator |
0; 1; 39; 15; 48; 11 | — |
| SECONDARY Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) |
170; 153; 108; 86 | — |
| SECONDARY Number of Participants With a Human Anti-human Antibody (HAHA) Positive Result at Indicated Time Points |
8; 1; 0; 2; 0; 2 | — |
| SECONDARY Number of Participants With Autoimmune Hemolytic Anaemia (AIHA) |
3; 2 | — |
| SECONDARY Number of Participants With Drug Related Infections Reported as AEs and SAEs of Maximum Severity of Grade 3 or Higher |
19; 11; 25; 21 | — |
| SECONDARY Number of Participants With at Least One Grade 3/Grade 4 Myelosuppression Adverse Events |
126; 118 | — |
| SECONDARY Number of Participants Who Received no Transfusion or at Least One Transfusion During the Study |
125; 99; 56; 79 | — |
| SECONDARY Mean Level of Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM |
1.0; 0.9; 8.7; 8.2; 0.6; 0.8 | — |
| SECONDARY Change From Baseline in Cluster of Differentiation (CD) Cell Counts, CD5+ and CD19+ |
43180.6; 53208.7; 2656.9; 9244.0; 2057.4; 10318.8 | — |
| SECONDARY Change From Baseline in Cell Counts, CD5- CD19+ |
4817.8; 6959.1; 5996.7; 2041.3; 239.0; 351.7 | — |
| SECONDARY Prognostic and Biological Markers Correlating With Clinical Response |
79; 78; 22; 26; 29; 19 | — |
| SECONDARY Changes in Patient Reported Outcome (PRO) Measures and Scores for European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16) |
-8.5; -9.0; -9.7; -9.8; -8.2; -10.9 | — |
| SECONDARY Change From Baseline in Patient Reported Outcome (PRO) as Assessed by EuroQoL Five-Dimension (EQ-5D) Score at Indicated Visit |
0.0; 0.0; 0.1; 0.0; 0.0; 0.1 | — |
| SECONDARY Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score |
0.5; -1.9; -0.2; -3.9; -0.7; -7.4 | — |
| SECONDARY Mean of Health Change Questionnaire (HCQ) |
2.6; 2.8; 3.0; 3.2; 3.0; 2.8 | — |
| SECONDARY Mean Area Under the Time-concentration Curve (AUC) Curve Over the Dosing Interval (AUC[0-tau]) of Ofatumumab |
3554.910; 34109.67; 67069.79; 84620.05; 89091.35; 96829.23 | — |
| SECONDARY Maximum Concentration (Cmax) and Observed Drug Concentration Prior to the Next Dose (Ctrough) of Ofatumumab |
61.355; 241.192; 312.745; 3.551; 9.496; 24.281 | — |
| SECONDARY Time of Occurrence of Cmax (Tmax) of Ofatumumab |
6.106; 5.004; 4.878 | — |
Eligibility Criteria
Key Inclusion Criteria
- confirmed and active CLL requiring treatment
- at least one previous treatment for CLL and having achieved a complete or partial remission/response but after a period of 6 or more months, shows evidence of disease progression
- fully active at a minimum or fully capable of selfcare and up and about more than 50% of waking hours
- age 18yrs or older
- signed written informed consent
Key Exclusion Criteria
- diagnosis of refractory CLL (failure to achieve a complete or partial remission/response or disease progression within 6 months of last anti-CLL treatment
- abnormal/inadequate blood values, liver and kidney function
- certain heart problems, serious significant diseases, AIHA, other current cancers or within the last 5 years
- active or chronic infections
- use of drugs to suppress allergic or inflammatory responses (glucocorticoids)
- CLL transformation
- CLL central nervous system involvement
- current participation in other clinical study
- inability to comply with the protocol activities
- lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception
Data sourced from ClinicalTrials.gov (NCT00824265) and the linked publication. 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.