Trial · NCT00936611
LBH589 in Relapsed or Relapsed and Refractory Waldenstrom's Macroglobulinemia
NCT00936611, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2021-01-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. LBH589 in Relapsed or Relapsed and Refractory Waldenstrom's Macroglobulinemia. Trials, record NCT00936611. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00936611
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LBH589 in Relapsed or Relapsed and Refractory Waldenstrom's Macroglobulinemia
- NCT number
- NCT00936611
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 39 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Waldenstrom's Macroglobulinemia
- Interventions
- LBH589
- First posted
- 2009-07-10
- Last updated
- 2021-01-28
- Results first posted
- 2021-01-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate | Assessed after 2nd cycle and then every subsequent cycle for 6 cycles. The median number of completed cycles of therapy was 5 (0- 32). As such observed up to ~32 months. | Overall response rate is percentage of participants with complete (CR), very good partial (VGPR), partial (PR), or minimal response (MR) as best response during treatment. CR * Disappearance of monoclonal protein by immunofixation * No histologic evidence of bone marrow involvement * Resolution of any adenopathy/organomegaly (confirmed by CT scan), or signs or symptoms attributable to WM. * Second immunofixation required for confirmation. VGPR -At least 90% reduction of serum monoclonal IgM concentration on protein electrophoresis. PR * At least 50% reduction of serum monoclonal IgM concentration on protein electrophoresis and at least 50% decrease in adenopathy/organomegaly on physical examination or on CT scan. * No new symptoms or signs of active disease. MR * At least 25% but less than 50% reduction of serum monoclonal IgM by protein electrophoresis. * No new symptoms or signs of active disease. |
| Secondary | Median Progression Free Survival | Assessed after 2nd cycle and then every subsequent cycle for 6 cycles and then every 3 months. If taken off treatment at cycle 2 for disease progression, assessed every 3 months. The median (range) follow up from treatment start is 7.7 month (0.9 - 29.7). | Progression free survival (PFS) is defined as the time from start of treatment to disease progression or death from any cause as estimated by Kaplan Meier methods. Patients who have not progressed and are alive are censored at the date the patient is known to be progression-free. |
| Secondary | Median Time to Progression | Assessed after 2nd cycle and then every subsequent cycle for 6 cycles and then every 3 months. If taken off treatment at cycle 2 for disease progression, assessed every 3 months. The median (range) follow up from treatment start is 7.7 month (0.9 - 29.7). | Time to progression (TTP) is defined as the time from start of treatment to progression. Patients who have not progressed are censored at the date the patient is last known to be progression free. |
| Secondary | Median Duration of Response | Assessed after 2nd cycle and then every subsequent cycle for 6 cycles and then every 3 months. If taken off treatment at cycle 2 for disease progression, assessed every 3 months. The median (range) follow up from treatment start is 7.7 month (0.9 - 29.7). | Duration of response DR is defined as the time from the date of first response after treatment to the date of disease progression Patients who have died for any cause or are alive without progression are censored at the date the patient is last know to be progression-free. Duration of response DR is defined as the time from the date of first response after treatment to the date of disease progression or death for any cause. Patients who are alive without progression are censored at the date the patient is last know to be progression-free. |
| Secondary | Number of Participants With Grade 3 and 4 Treatment-Related Thrombocytopenia | Assessed after 2nd cycle, every subsequent cycle for 6 cycles and then every 3 months. Once off-treatment, adverse events will be assessed for 30 days. The median (range) number of completed cycles of therapy was 5 (0- 32). Therefore, up to ~33 months. | Grade 3 thrombocytopenia is defined as having 25,000-50,000 /uL platelets Grade 4 thrombocytopenia is defined as having \< 25,000 /uL platelets |
| Secondary | Acetylated Histone H3 and Overall Response Association | Bone marrow biopsies were obtained at the start of treatment (baseline) and after the 6th cycle. | Acetylated-histone-H3 levels were obtained through bone marrow biopsies and measured using established methods. This analysis aimed to analyze the association between overall response and percent change of acetylated histone h3 in samples using a paired t-test. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate | Assessed after 2nd cycle and then every subsequent cycle for 6 cycles. The median number of completed cycles of therapy was 5 (0- 32). As such observed up to ~32 months. | percentage of participants | NUMBER | |
| SECONDARY | Median Progression Free Survival | Assessed after 2nd cycle and then every subsequent cycle for 6 cycles and then every 3 months. If taken off treatment at cycle 2 for disease progression, assessed every 3 months. The median (range) follow up from treatment start is 7.7 month (0.9 - 29.7). | months | MEDIAN | |
| SECONDARY | Median Time to Progression | Assessed after 2nd cycle and then every subsequent cycle for 6 cycles and then every 3 months. If taken off treatment at cycle 2 for disease progression, assessed every 3 months. The median (range) follow up from treatment start is 7.7 month (0.9 - 29.7). | months | MEDIAN | |
| SECONDARY | Median Duration of Response | Assessed after 2nd cycle and then every subsequent cycle for 6 cycles and then every 3 months. If taken off treatment at cycle 2 for disease progression, assessed every 3 months. The median (range) follow up from treatment start is 7.7 month (0.9 - 29.7). | months | MEDIAN | |
| SECONDARY | Number of Participants With Grade 3 and 4 Treatment-Related Thrombocytopenia | Assessed after 2nd cycle, every subsequent cycle for 6 cycles and then every 3 months. Once off-treatment, adverse events will be assessed for 30 days. The median (range) number of completed cycles of therapy was 5 (0- 32). Therefore, up to ~33 months. | participants | NUMBER | |
| SECONDARY | Acetylated Histone H3 and Overall Response Association | Bone marrow biopsies were obtained at the start of treatment (baseline) and after the 6th cycle. | Only three complete sample (baseline and post-therapy) were ascertained. The difference in percentage of acetylated histone h3 were not large enough to conduct the correlative analysis. |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate | LBH589 | 47 | 90% Confidence Interval 33 to 62 | percentage of participants | |
| Median Progression Free Survival | LBH589 | 6.6 | 90% Confidence Interval 5.5 to 14.8 | months | |
| Median Time to Progression | LBH589 | 6.6 | 90% Confidence Interval 5.5 to 14.8 | months | |
| Median Duration of Response | LBH589 | 6.9 | 90% Confidence Interval 3.1 to 18.9 | months | |
| Number of Participants With Grade 3 and 4 Treatment-Related Thrombocytopenia | LBH589 | 24 | participants |
Source ClinicalTrials.gov
Participant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LBH589 | 39 | |
| Overall Study | Treated | LBH589 | 36 | |
| Overall Study | Starting Dose Reduction: 30 mg to 25 mg | LBH589 | 12 | |
| Overall Study | COMPLETED | LBH589 | 0 | |
| Overall Study | NOT COMPLETED | LBH589 | 39 |
Source ClinicalTrials.gov
Adverse events115
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 | Infection w/ gr3-4 neut, upper airway | Infections and infestations | LBH589 | 1 | 39 | |
| other | Infection Gr0-2 neut, dental-tooth | Infections and infestations | LBH589 | 1 | 39 | |
| other | Infection Gr0-2 neut, sinus | Infections and infestations | LBH589 | 2 | 39 | |
| other | Infection Gr0-2 neut, upper airway | Infections and infestations | LBH589 | 1 | 39 | |
| other | Infection Gr0-2 neut, urinary tract | Infections and infestations | LBH589 | 1 | 39 | |
| other | Infection w/ unk ANC middle ear | Infections and infestations | LBH589 | 1 | 39 | |
| other | Intra-op injury Other (Specify) | Injury, poisoning and procedural complications | LBH589 | 1 | 39 | |
| other | Hemoglobin | Blood and lymphatic system disorders | LBH589 | 14 | 39 | |
| other | Lymph node, pain | Blood and lymphatic system disorders | LBH589 | 2 | 39 | |
| other | Palpitations | Cardiac disorders | LBH589 | 4 | 39 |
1 to 10 of 115Source ClinicalTrials.gov
See all 115 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LBH589 | 28 | 39 |
| Total, other adverse events | LBH589 | 36 | 39 |
| Total, serious adverse events | LBH589 | 29 | 39 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23287861 | RESULT |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00936611
GET https://conductscience.org/api/trials/v1/NCT00936611/events?page=2