Trial · NCT00824265
Ofatumumab Added to Fludarabine-Cyclophosphamide vs Fludarabine-Cyclophosphamide Combination in Relapsed Subjects With Chronic Lymphocytic Leukemia
NCT00824265, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2016-07-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ofatumumab Added to Fludarabine-Cyclophosphamide vs Fludarabine-Cyclophosphamide Combination in Relapsed Subjects With Chronic Lymphocytic Leukemia. Trials, record NCT00824265. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00824265
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ofatumumab Added to Fludarabine-Cyclophosphamide vs Fludarabine-Cyclophosphamide Combination in Relapsed Subjects With Chronic Lymphocytic Leukemia
- NCT number
- NCT00824265
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 365 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Leukaemia, Lymphocytic, Chronic
- Interventions
- OFC Infusion, FC infusion
- First posted
- 2009-01-16
- Last updated
- 2020-06-18
- Results first posted
- 2016-07-25
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS), as Assessed by the Independent Review Committee (IRC) | From randomization up to 5 years after last dose of study drug | PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression (progressive disease,PD) and the date of death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlargerd lymph nodes (\>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia (CLL). |
| Secondary | Overall Survival (OS) | From randomization up to 5 years after last dose of study drug | Overall survival is defined as the time from randomization to death due to any cause. Each participant was followed at the time when the last IRC-assessed PFS events occurred. Participants who had not died were censored at the date of last contact. |
| Secondary | Time to Response, as Assessed by the IRC | From randomization up to 5 years after last dose of study drug | Time to response is defined as the time from randomization to the first response. Complete Response/remission(CR) all the criteria at least 2 months after last treatment: no lymphadenopathy(Ly) \> 1.5 cm/ hepatomegaly/spleenomegaly/constitutional symptoms; neutrophils \>1500 per microliter(µL), platelets(PL) \>100,000/µL, hemoglobin(Hb) \>11 grams/deciliter(g/dL), lymphocytes(LC) \<4000/µL, bone marrow(BM) sample must be normocellular for age, \<30% LC, no lymphoid nodule. Incomplete bone marrow recovery(CRi): CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. Partial Remission/response(PR): \>=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL \>100,000/µL or 50% improvement over Baseline(BL), Hb \>11 g/dL or 50% improvement over BL. Nodular PR(nPR): persistent nodules BM. |
| Secondary | Duration of Response (DOR), as Assessed by the IRC | From time of initial response to disease progression or death, whichever came first (up to 5 years after the last dose of study drug) | DOR is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of PD or death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlargerd lymph nodes (\>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. |
| Secondary | Time to Progression, as Assessed by the IRC | From randomization up to 5 years after the last dose of study drug | Time to progression is defined as the time from the date of randomization to PD. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlargerd lymph nodes (\>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. |
| Secondary | Time to Next Therapy | From the start of study drug until the start of the next anti-CLL therapy (up to 5 years after the last dose of study drug) | Time to next therapy is defined as the time from randomization until the start of the next-line of treatment. Data are presented for participants who took anti-cancer therapies and participants in the ITT population. |
| Secondary | Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status | Cycle 2 Day1, Cycle 3 Day1, Cycle 4 Day1, Cycle 5 Day1, Cycle 6 Day1, follow up (FU) at 1Month (M) after study drug therapy, 3M, then every 3 month up to 5 year (up to 60 months) | The ECOG performance status scales and criteria are used by doctors and researchers to assess how a participant's disease is progressing, how the disease affects the daily living, and determines appropriate treatment and prognosis. ECOG performance status are measured at Cycle 2 Day1, Cycle 3 Day1, Cycle 4 Day1, Cycle 5 Day1 and Cycle 6 Day1. During follow period, 1 M after study drug therapy, then every 3 month up to 5 year (up to 60 months). Improvement is defined as a decrease from baseline by at least one step on the ECOG performance status scale (yes/no). |
| Secondary | Number of Participants With no B-Symptoms or at Least One B-symptoms Over the Time | Screening, Cycle1 Day 1, Cycle 2 Day1, Cycle 3 Day1, Cycle 4 Day1, Cycle 5 Day1, Cycle 6 Day 1 and During at 1M after study drug therapy, 3M, then every 3 M up to 5 year (up to 60 months) | Participants with no B-symptoms (B-Sy) (no night sweat, no weight loss, no fever and no extreme fatigue) and at least one indicated B-sy(night sweats, weight loss, fever or extreme fatigue) were presented at Screening, Cycle 1 Day 1, Cycle 2 Day1, Cycle 3 Day1, Cycle 4 Day1, Cycle 5 Day1, Cycle 6 Day 1 and during follow up period at 1 M after study drug therapy, then every 3 M up to 5 year (up to 60 months). |
| Secondary | Percentage of Participants With the Best Overall Response (OR), as Assessed by the IRC | From randomization up to 5 years after last dose of study drug | OR is defined as the number of participants achieving an objective response (complete response \[CR\], CR with incomplete bone marrow recovery \[CRi\], partial response \[PR\], and nodular PR \[nPR\]). CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) \> 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils \>1500 per microliter (µL), platelets (PL) \>100,000/µL, hemoglobin (Hb) \>11 grams/deciliter (g/dL), lymphocytes (LC) \<4000/µL, bone marrow (BM) sample must be normocellular for age, \<30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: \>=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL \>100,000/µL or 50% improvement over Baseline (BL), Hb \>11 g/dL or 50% improvement over BL. nPR: persistent nodules BM. |
| Secondary | Percentage of Participants With the Best OR, as Assessed by the Investigator | From randomization up to 5 years after last dose of study drug | OR is defined as the number of participants achieving an objective response (complete response \[CR\], CR with incomplete bone marrow recovery \[CRi\], partial response \[PR\], and nodular PR \[nPR\]). CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) \> 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils \>1500 per microliter (µL), platelets (PL) \>100,000/µL, hemoglobin (Hb) \>11 grams/deciliter (g/dL), lymphocytes (LC) \<4000/µL, bone marrow (BM) sample must be normocellular for age, \<30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: \>=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL \>100,000/µL or 50% improvement over Baseline (BL), Hb \>11 g/dL or 50% improvement over BL. nPR: persistent nodules BM. Responder = CR + CRi + NPR + PR |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS), as Assessed by the Independent Review Committee (IRC) | From randomization up to 5 years after last dose of study drug | Intent-to-Treat (ITT) Population: all participants randomized and received study drug. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization up to 5 years after last dose of study drug | ITT Population. | Months | MEDIAN |
| SECONDARY | Time to Response, as Assessed by the IRC | From randomization up to 5 years after last dose of study drug | ITT Population. Participants with unknown or missing responses were considered as non-responders. Only responders were included in the analysis. | Months | MEDIAN |
| SECONDARY | Duration of Response (DOR), as Assessed by the IRC | From time of initial response to disease progression or death, whichever came first (up to 5 years after the last dose of study drug) | ITT Population. Par with unknown or missing responses were considered as non-responders, only responders were included in this analysis. | Months | MEDIAN |
| SECONDARY | Time to Progression, as Assessed by the IRC | From randomization up to 5 years after the last dose of study drug | ITT Population. | Months | MEDIAN |
| SECONDARY | Time to Next Therapy | From the start of study drug until the start of the next anti-CLL therapy (up to 5 years after the last dose of study drug) | ITT Population | Months | MEDIAN |
| SECONDARY | Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status | Cycle 2 Day1, Cycle 3 Day1, Cycle 4 Day1, Cycle 5 Day1, Cycle 6 Day1, follow up (FU) at 1Month (M) after study drug therapy, 3M, then every 3 month up to 5 year (up to 60 months) | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Participants | NUMBER |
| SECONDARY | Number of Participants With no B-Symptoms or at Least One B-symptoms Over the Time | Screening, Cycle1 Day 1, Cycle 2 Day1, Cycle 3 Day1, Cycle 4 Day1, Cycle 5 Day1, Cycle 6 Day 1 and During at 1M after study drug therapy, 3M, then every 3 M up to 5 year (up to 60 months) | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Participants | NUMBER |
| SECONDARY | Percentage of Participants With the Best Overall Response (OR), as Assessed by the IRC | From randomization up to 5 years after last dose of study drug | ITT Population | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With the Best OR, as Assessed by the Investigator | From randomization up to 5 years after last dose of study drug | ITT Population | Percentage of participants | NUMBER |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group972
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS), as Assessed by the Independent Review Committee (IRC) | Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects | 28.94 | 95% Confidence Interval 22.80 to 35.88 | Months | |
| Progression-free Survival (PFS), as Assessed by the Independent Review Committee (IRC) | Fludarabine + Cyclophosphamide_ ITT Subjects | 18.83 | 95% Confidence Interval 14.42 to 25.82 | Months | |
| Overall Survival (OS) | Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects | 62.65 | 95% Confidence Interval 44.58 to NA | Months | |
| Overall Survival (OS) | Fludarabine + Cyclophosphamide_ ITT Subjects | 46.23 | 95% Confidence Interval 37.72 to 56.57 | Months | |
| Time to Response, as Assessed by the IRC | Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects | 0.99 | 95% Confidence Interval 0.95 to 1.08 | Months | |
| Time to Response, as Assessed by the IRC | Fludarabine + Cyclophosphamide_ ITT Subjects | 0.99 | 95% Confidence Interval 0.95 to 1.18 | Months | |
| Duration of Response (DOR), as Assessed by the IRC | Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects | 29.63 | 95% Confidence Interval 25.03 to 41.46 | Months | |
| Duration of Response (DOR), as Assessed by the IRC | Fludarabine + Cyclophosphamide_ ITT Subjects | 24.90 | 95% Confidence Interval 18.99 to 28.12 | Months | |
| Time to Progression, as Assessed by the IRC | Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects | 42.12 | 95% Confidence Interval 28.94 to 47.67 | Months | |
| Time to Progression, as Assessed by the IRC | Fludarabine + Cyclophosphamide_ ITT Subjects | 26.78 | 95% Confidence Interval 22.51 to 31.87 | Months |
1 to 10 of 972Source ClinicalTrials.gov
See all 972 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Phase | STARTED | Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects | 183 | |
| Treatment Phase | STARTED | Fludarabine + Cyclophosphamide_ ITT Subjects | 182 | |
| Treatment Phase | COMPLETED | Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects | 119 | |
| Treatment Phase | COMPLETED | Fludarabine + Cyclophosphamide_ ITT Subjects | 102 | |
| Treatment Phase | NOT COMPLETED | Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects | 64 | |
| Treatment Phase | NOT COMPLETED | Fludarabine + Cyclophosphamide_ ITT Subjects | 80 | |
| Follow-up Phase | STARTED | Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects | 172 | |
| Follow-up Phase | STARTED | Fludarabine + Cyclophosphamide_ ITT Subjects | 160 | |
| Follow-up Phase | COMPLETED | Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects | 154 | |
| Follow-up Phase | COMPLETED | Fludarabine + Cyclophosphamide_ ITT Subjects | 129 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events486
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects | 24 | 181 | |
| other | Anaemia | Blood and lymphatic system disorders | Fludarabine + Cyclophosphamide_ ITT Subjects | 38 | 178 | |
| other | Leukopenia | Blood and lymphatic system disorders | Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects | 27 | 181 | |
| other | Leukopenia | Blood and lymphatic system disorders | Fludarabine + Cyclophosphamide_ ITT Subjects | 10 | 178 | |
| other | Neutropenia | Blood and lymphatic system disorders | Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects | 93 | 181 | |
| other | Neutropenia | Blood and lymphatic system disorders | Fludarabine + Cyclophosphamide_ ITT Subjects | 62 | 178 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects | 38 | 181 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Fludarabine + Cyclophosphamide_ ITT Subjects | 55 | 178 | |
| other | Constipation | Gastrointestinal disorders | Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects | 8 | 181 | |
| other | Constipation | Gastrointestinal disorders | Fludarabine + Cyclophosphamide_ ITT Subjects | 11 | 178 |
1 to 10 of 486Source ClinicalTrials.gov
See all 486 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects | 40 | 181 |
| Total, all-cause mortality | Fludarabine + Cyclophosphamide_ ITT Subjects | 42 | 178 |
| Total, other adverse events | Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects | 149 | 181 |
| Total, other adverse events | Fludarabine + Cyclophosphamide_ ITT Subjects | 123 | 178 |
| Total, serious adverse events | Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects | 108 | 181 |
| Total, serious adverse events | Fludarabine + Cyclophosphamide_ ITT Subjects | 86 | 178 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects vs Fludarabine + Cyclophosphamide_ ITT Subjects: Number of Participants With at Least One Grade 3/Grade 4 Myelosuppression Adverse Events | Trial comparisons |
| Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects vs Fludarabine + Cyclophosphamide_ ITT Subjects: Number of Participants With Autoimmune Hemolytic Anaemia (AIHA) | Trial comparisons |
| Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects vs Fludarabine + Cyclophosphamide_ ITT Subjects: deaths from any cause | Trial comparisons |
| Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects vs Fludarabine + Cyclophosphamide_ ITT Subjects: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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