Trial · NCT00811733
A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia
NCT00811733, Phase 2, Completed, GlaxoSmithKline; results first posted 2012-04-30
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ConductScience Library. A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia. Trials, record NCT00811733. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00811733
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia
- NCT number
- NCT00811733
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 37 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Waldenstrom Macroglobulinaemia
- Interventions
- Ofatumumab
- First posted
- 2008-12-19
- Last updated
- 2017-05-30
- Results first posted
- 2012-04-30
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Overall Response (OR) for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator | Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment | OR (based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM) included Complete Response (CR), Partial Response (PR), or a Minor Response (MR). CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =\<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a \>=50% reduction from baseline in the SM IgM concentration. MR: \>=25%, but a \<50% reduction of SM IgM from baseline. |
| Primary | Number of Participants With OR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator | Baseline and up to Study Week 16 | OR (based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM) included Complete Response (CR), Partial Response (PR), or a Minor Response (MR). CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =\<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a \>=50% reduction from baseline in the SM IgM concentration. MR: \>=25%, but a \<50% reduction of SM IgM from baseline. |
| Secondary | Number of Participants With CR, PR, and MR for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator | Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment | Response criteria were based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM. CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =\<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a \>=50% reduction from baseline in the SM IgM concentration. MR: \>=25%, but a \<50% reduction of SM IgM from baseline. |
| Secondary | Number of Participants With CR, PR, and MR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator | Baseline and up to Study Week 16 | Response criteria were based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM. CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =\<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a \>=50% reduction from baseline in the SM IgM concentration. MR: \>=25%, but a \<50% reduction of SM IgM from baseline. |
| Secondary | Number of Participants With IgM Flare for Cycle 1 Response (Including the Redosing Cycle) | Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment | IgM is a basic antibody that is produced by B cells. It is the first antibody to appear in response to initial exposure to antigen. IgM flare is defined as an IgM level that increases by \>25% from baseline (BL) and is associated with a response to treatment. Avoidance of IgM flare indicates the lack of an increase in IgM of \>25% from BL. |
| Secondary | Duration of Response for All Responders (CR, PR, MR), as Assessed by the Investigator | From baseline up to approximately 5 years | Duration of response is defined as the time from the initial response to relapse/disease progression (DP) or death. DP for CR is defined as the reappearance of the IgM protein, new signs/symptoms attributable to WM, evidence of active disease or recurrence of bone marrow involvement by lymphoplasmacytic cells, or the appearance of any new lymph node \>=1.5 centimeters on any axis. Progression for PR/MR is either a \>=25% increase in IgM from the lowest attained response value or progression of lymphadenopathy, organomegaly, cytopenias, or other clinically significant signs/symptoms caused by WM. |
| Secondary | Progression-free Survival | From baseline up to approximately 5 years | Time to disease progression is defined as the time from baseline to disease progression or death. |
| Secondary | Time to Response for Responders | From baseline up to approximately 5 years | Time to response is defined as the time from baseline to the first response date. |
| Secondary | Overall Survival | From baseline up to approximately 5 years | Overall survival is defined as the time from baseline until death due to any cause. |
| Secondary | Clearance of Ofatumumab | From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7 | Clearance (CL) is defined as the volume of plasma that is cleared of drug per unit of time. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Overall Response (OR) for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator | Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment | Intent-to-Treat (ITT) Population: all participants who were considered eligible for treatment and who had been exposed to study drug irrespective of the planned course of treatment. | participants | NUMBER |
| PRIMARY | Number of Participants With OR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator | Baseline and up to Study Week 16 | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With CR, PR, and MR for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator | Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With CR, PR, and MR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator | Baseline and up to Study Week 16 | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With IgM Flare for Cycle 1 Response (Including the Redosing Cycle) | Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment | ITT Population. Only those participants who received Cycle 1 treatment (including the Redosing Cycle) were assessed. | participants | NUMBER |
| SECONDARY | Duration of Response for All Responders (CR, PR, MR), as Assessed by the Investigator | From baseline up to approximately 5 years | ITT Population. Only those participants classified as responders were included in the analysis. Participants who had disease progression or death were counted as events, and other participants were censored at the date of the last adequate assessment in the study. | days | MEDIAN |
| SECONDARY | Progression-free Survival | From baseline up to approximately 5 years | ITT Population. Participants who experienced disease progression or death were counted as events, and other participants were censored at the time of the last adequate assessment in the study. | days | MEDIAN |
| SECONDARY | Time to Response for Responders | From baseline up to approximately 5 years | ITT Population. Only participants classified as responders (CR, PR, and MR) were assessed. | days | MEDIAN |
| SECONDARY | Overall Survival | From baseline up to approximately 5 years | ITT Population. Only those participants who died during the study and during the follow-up period were assessed. | ||
| SECONDARY | Clearance of Ofatumumab | From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7 | Pharmacokinetic (PK) Population: all participants from whom a PK sample was obtained and analyzed. Data were provided for the number of participants for whom the parameter could be determined. | milliliters/hour (ml/hr) | GEOMETRIC_MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group348
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Overall Response (OR) for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator | 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | 7 | participants | ||
| Number of Participants With Overall Response (OR) for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator | 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | 15 | participants | ||
| Number of Participants With OR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator | 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | 5 | participants | ||
| Number of Participants With OR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator | 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | 14 | participants | ||
| Number of Participants With CR, PR, and MR for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator | 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | CR | 0 | participants | |
| Number of Participants With CR, PR, and MR for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator | 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | CR | 0 | participants | |
| Number of Participants With CR, PR, and MR for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator | 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | PR | 4 | participants | |
| Number of Participants With CR, PR, and MR for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator | 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | PR | 11 | participants | |
| Number of Participants With CR, PR, and MR for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator | 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | MR | 3 | participants | |
| Number of Participants With CR, PR, and MR for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator | 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | MR | 4 | participants |
1 to 10 of 348Source ClinicalTrials.gov
See all 348 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | 15 | |
| Overall Study | STARTED | 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | 22 | |
| Overall Study | COMPLETED | 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | 4 | |
| Overall Study | COMPLETED | 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | 12 | |
| Overall Study | NOT COMPLETED | 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | 11 | |
| Overall Study | NOT COMPLETED | 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | 10 |
Source ClinicalTrials.gov
Adverse events262
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 | Throat irritation | Respiratory, thoracic and mediastinal disorders | 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | 7 | 15 | |
| other | Throat irritation | Respiratory, thoracic and mediastinal disorders | 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | 3 | 22 | |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | 2 | 15 | |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | 5 | 22 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | 4 | 15 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | 2 | 22 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | 3 | 15 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | 3 | 22 | |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | 3 | 15 | |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | 3 | 22 |
1 to 10 of 262Source ClinicalTrials.gov
See all 262 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | ||
| Total, all-cause mortality | 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | ||
| Total, other adverse events | 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | 15 | 15 |
| Total, other adverse events | 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | 20 | 22 |
| Total, serious adverse events | 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | 5 | 15 |
| Total, serious adverse events | 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | 7 | 22 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27914971 | DERIVED |
Source PubMed
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 |
|---|---|
300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 vs 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5: Number of Participants With OR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator | Trial comparisons |
300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 vs 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5: Number of Participants With Overall Response (OR) for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator | Trial comparisons |
300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 vs 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5: Number of Participants With at Least One Confirmed Positive Post-ofatumumab HAHA Result | Trial comparisons |
| 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 vs 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5: 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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00811733
GET https://conductscience.org/api/trials/v1/NCT00811733/registered?page=2