Trial · NCT00748189
Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia
NCT00748189, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2014-03-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia. Trials, record NCT00748189. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00748189
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia
- NCT number
- NCT00748189
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 447 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Leukaemia, Lymphocytic, Chronic
- Interventions
- chlorambucil, tablets, ofatumumab (GSK1841157) infusion
- First posted
- 2008-09-08
- Last updated
- 2019-06-25
- Results first posted
- 2014-03-26
Source ClinicalTrials.gov
Registered outcomes25
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 to the date of first documented disease progression or death due to any cause, whichever occured first, reported between day of first patient randomized up to about 49 months | PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression (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 enlarged 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. Par. who were alive and had not progressed at the time of analysis or if a progression event or death occurred after extensive lost-to-follow-up time or if new anti-cancer therapy was started were censored at the date of the last visit with adequate assessment. |
| Secondary | Number of Participants With the Best Overall Response (OR), as Assessed by the IRC | From randomization until the 259th PFS event occurred, up to about 49 months | 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 | Number of Participants Who Were Negative for Minimal Residual Disease (MRD) | From randomization until the 259th PFS event occurred (Median follow-up approximately 28.9 months) | MRD was performed by flow cytometry on a bone marrow or peripheral blood sample taken at least 2 months after final treatment. MRD negative was defined as less than one CLL cell per 10000 leukocytes. |
| Secondary | Overall Survival | From randomization up to about 111 months | Overall survival is defined as the time from randomization to death due to any cause. Each participant was followed at the time when the total 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 uo to about 27 months | Time to response is defined as the time from randomization to the first response (CR, CRi, nPR, or PR). 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. Participants with unknown or missing responses were considered as non-responders. Only responders (CR, CRi, PR, nPR) were included in the analysis. |
| Secondary | Duration of Response (DOR), as Assessed by the IRC | From randomization up to about 43 months | 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 enlarged 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. Par. who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time (\>= 12 weeks) were censored at the date of the last visit with adequate assessment. Par. with unknown or missing responses were considered as non-responders. |
| Secondary | Time to Progression, as Assessed by the IRC | From randomization up to about 49 months | Time to progression is defined as the time from the date of randomization to disease progression (PD). PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged 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. Participants who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time were censored at the date of the last visit with adequate assessment. |
| Secondary | Time to Next Therapy | From randomization up to about 49 months | Time to next therapy is defined as the time from randomization until the start of the next-line of treatment. |
| Secondary | Number of Participants With Improvement in ECOG Performance Status of 0 or 1 | Baseline, Cycle 3 Day 1, 1 month Follow-up | 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. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead. Participants with an ECOG performance status of 0 or 1 are shown.. |
| Secondary | Number of Participants With Improvement in Constitutional Symptoms (CS) | Baseline, Cycle 3 Day 1, and 1 month Follow-up | Assessment for the presence of the following symptoms were performed at Screening, Day 1 of each treatment cycle and at every Follow-up visit: night sweats (without signs of infection); unexplained, unintentional weight loss \>= 10% within the previous 6 months; recurrent, unexplained fever of greater than 38 degrees celsius or 100.5 degrees fahrenheit for 2 weeks; and extreme fatigue. The best response refers to overall best response in terms of CR, CRi, PR or nPR. Data are presented for constitutional response= yes and no. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
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 to the date of first documented disease progression or death due to any cause, whichever occured first, reported between day of first patient randomized up to about 49 months | Intent-to-Treat (ITT) Population: all par. randomized to study treatment regardless of whether or not they received treatment. PFS was assessed by a blinded independent review committee according to the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines. | Months | MEDIAN |
| SECONDARY | Number of Participants With the Best Overall Response (OR), as Assessed by the IRC | From randomization until the 259th PFS event occurred, up to about 49 months | ITT population. Only those participants with data available at the indicated time points were analyzed. OR was according to the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines. The 95% exact binomial confidence interval is for CR+CRi+nPR+PR. | Participants | NUMBER |
| SECONDARY | Number of Participants Who Were Negative for Minimal Residual Disease (MRD) | From randomization until the 259th PFS event occurred (Median follow-up approximately 28.9 months) | ITT population. Only those participants with data available at the indicated time points were analyzed. | Participants | NUMBER |
| SECONDARY | Overall Survival | From randomization up to about 111 months | ITT population. Only those participants with data available at the indicated time points were analyzed. | Months | MEDIAN |
| SECONDARY | Time to Response, as Assessed by the IRC | From randomization uo to about 27 months | ITT population. Time to response was measured using the International Workshop for CLL (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines 2008. | Months | MEDIAN |
| SECONDARY | Duration of Response (DOR), as Assessed by the IRC | From randomization up to about 43 months | ITT population. Only those participants with data available at the indicated time points were analyzed. Only responders (CR, CRi, PR, nPR) were included in the analysis. | Months | MEDIAN |
| SECONDARY | Time to Progression, as Assessed by the IRC | From randomization up to about 49 months | ITT population. Only those participants with data available at the indicated time points were analyzed. | Months | MEDIAN |
| SECONDARY | Time to Next Therapy | From randomization up to about 49 months | ITT population. Only those participants with data available at the indicated time points were analyzed. | Months | MEDIAN |
| SECONDARY | Number of Participants With Improvement in ECOG Performance Status of 0 or 1 | Baseline, Cycle 3 Day 1, 1 month Follow-up | ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population. | Participants | NUMBER |
| SECONDARY | Number of Participants With Improvement in Constitutional Symptoms (CS) | Baseline, Cycle 3 Day 1, and 1 month Follow-up | ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population. | Participants | NUMBER |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group115
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) | Chlorambucil | 13.1 | 95% Confidence Interval 10.6 to 13.8 | Months | |
| Progression-Free Survival (PFS), as Assessed by the Independent Review Committee (IRC) | Ofatumumab + Chlorambucil | 22.4 | 95% Confidence Interval 19.0 to 25.2 | Months | |
| Number of Participants With the Best Overall Response (OR), as Assessed by the IRC | Chlorambucil | CR | 3 | Participants | |
| Number of Participants With the Best Overall Response (OR), as Assessed by the IRC | Ofatumumab + Chlorambucil | CR | 27 | Participants | |
| Number of Participants With the Best Overall Response (OR), as Assessed by the IRC | Chlorambucil | CRi | 0 | Participants | |
| Number of Participants With the Best Overall Response (OR), as Assessed by the IRC | Ofatumumab + Chlorambucil | CRi | 5 | Participants | |
| Number of Participants With the Best Overall Response (OR), as Assessed by the IRC | Chlorambucil | nPR | 0 | Participants | |
| Number of Participants With the Best Overall Response (OR), as Assessed by the IRC | Ofatumumab + Chlorambucil | nPR | 1 | Participants | |
| Number of Participants With the Best Overall Response (OR), as Assessed by the IRC | Chlorambucil | PR | 152 | Participants | |
| Number of Participants With the Best Overall Response (OR), as Assessed by the IRC | Ofatumumab + Chlorambucil | PR | 149 | Participants |
1 to 10 of 115Source ClinicalTrials.gov
See all 115 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chlorambucil | 226 | |
| Overall Study | STARTED | Ofatumumab + Chlorambucil | 221 | |
| Overall Study | COMPLETED | Chlorambucil | 10 | |
| Overall Study | COMPLETED | Ofatumumab + Chlorambucil | 9 | |
| Overall Study | NOT COMPLETED | Chlorambucil | 216 | |
| Overall Study | NOT COMPLETED | Ofatumumab + Chlorambucil | 212 |
Source ClinicalTrials.gov
Adverse events426
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 | Chlorambucil | 27 | 227 | |
| other | Anaemia | Blood and lymphatic system disorders | Ofatumumab 1000 mg + Chlorambucil | 16 | 217 | |
| other | Anaemia | Blood and lymphatic system disorders | Total | 43 | 444 | |
| other | Leukopenia | Blood and lymphatic system disorders | Chlorambucil | 4 | 227 | |
| other | Leukopenia | Blood and lymphatic system disorders | Ofatumumab 1000 mg + Chlorambucil | 14 | 217 | |
| other | Leukopenia | Blood and lymphatic system disorders | Total | 18 | 444 | |
| other | Neutropenia | Blood and lymphatic system disorders | Chlorambucil | 36 | 227 | |
| other | Neutropenia | Blood and lymphatic system disorders | Ofatumumab 1000 mg + Chlorambucil | 57 | 217 | |
| other | Neutropenia | Blood and lymphatic system disorders | Total | 93 | 444 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Chlorambucil | 56 | 227 |
1 to 10 of 426Source ClinicalTrials.gov
See all 426 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chlorambucil | 99 | 227 |
| Total, all-cause mortality | Ofatumumab 1000 mg + Chlorambucil | 84 | 217 |
| Total, all-cause mortality | Total | 183 | 444 |
| Total, other adverse events | Chlorambucil | 175 | 227 |
| Total, other adverse events | Ofatumumab 1000 mg + Chlorambucil | 183 | 217 |
| Total, other adverse events | Total | 358 | 444 |
| Total, serious adverse events | Chlorambucil | 57 | 227 |
| Total, serious adverse events | Ofatumumab 1000 mg + Chlorambucil | 53 | 217 |
| Total, serious adverse events | Total | 110 | 444 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Chlorambucil vs Ofatumumab + Chlorambucil: Number of Participants With at Least One Grade 3/Grade 4 Myelosuppression (Anemia, Neutropenia, and Thrombocytopenia) | Trial comparisons |
| Chlorambucil vs Ofatumumab + Chlorambucil: Number of Participants With Autoimmune Hemolytic Anaemia (AIHA) Disease | 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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00748189
GET https://conductscience.org/api/trials/v1/NCT00748189/registered?page=2