Trial · NCT04273139
Ibrutinib + Venetoclax in Untreated WM
NCT04273139, Phase 2, Active not recruiting, Dana-Farber Cancer Institute; results first posted 2024-04-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ibrutinib + Venetoclax in Untreated WM. Trials, record NCT04273139. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04273139
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ibrutinib + Venetoclax in Untreated WM
- NCT number
- NCT04273139
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Waldenstrom Macroglobulinemia, MYD88 Gene Mutation
- Interventions
- IBRUTINIB, Venetoclax
- First posted
- 2020-02-17
- Last updated
- 2026-05-11
- Results first posted
- 2024-04-23
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Very Good Partial Response Within 24 Cycles of Therapy | The primary objective of VGPR within 24 cycles of therapy was assessed starting at Cycle 3 Day 1 through the End of Treatment visit, range of 2 to 21 months after the initiation of therapy. | Proportion of patients with VGPR to therapy within 24 cycles of therapy initiation. (VGPR is \>90% reduction in serum IgM from baseline) |
| Secondary | Number of Participants With Complete Response (CR) After 6 Cycles | 6 Cycles (28 day cycle) | Proportion of patients with a complete response after 6 cycles of therapy. A complete response (CR) is defined as having resolution of WM related symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. |
| Secondary | Number of Participants With Complete Response (CR) After 12 Cycles | 12 Cycles (28 day cycle) | Proportion of patients with a complete response after 12 cycles of therapy. A complete response (CR) is defined as having resolution of WM related symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. |
| Secondary | Number of Participants With Complete Response (CR) After 24 Cycles | Complete response to therapy was assessed starting at Cycle 3 Day 1 through the End of Treatment visit, range of 2 to 21 months after the initiation of therapy. | Proportion of patients with a complete response after 24 cycles of therapy. A complete response (CR) is defined as having resolution of WM related symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. |
| Secondary | Overall Response | 72 months | Proportion of patients with minor response (MR) , partial response (PR), very good partial response (VGPR), or complete response (CR) to therapy. |
| Secondary | Rate of VGPR at 30 Months | 30 Months | Proportion of patients with a VGPR at 30 months from beginning therapy. |
| Secondary | Median Time to Response | 24 months | Time from treatment initiation until achievement of a minor response (reduction in serum IgM \>25%) or better. |
| Secondary | Median Time to Major Response | 24 months | Time from treatment initiation until partial response or better (\>50% reduction in serum IgM) |
| Secondary | Progression Free Survival (PFS) at 24 Months | 24 months | Time from initiation of therapy until disease progression (\>25% increase in serum IgM and 500 mg/dL absolute increase). |
| Secondary | Progression Free Survival (PFS) at 36 Months | 36 Months | Time from initiation of therapy until disease progression (\>25% increase in serum IgM and 500 mg/dL absolute increase). |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes15
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 Very Good Partial Response Within 24 Cycles of Therapy | The primary objective of VGPR within 24 cycles of therapy was assessed starting at Cycle 3 Day 1 through the End of Treatment visit, range of 2 to 21 months after the initiation of therapy. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Complete Response (CR) After 6 Cycles | 6 Cycles (28 day cycle) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Complete Response (CR) After 12 Cycles | 12 Cycles (28 day cycle) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Complete Response (CR) After 24 Cycles | Complete response to therapy was assessed starting at Cycle 3 Day 1 through the End of Treatment visit, range of 2 to 21 months after the initiation of therapy. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Response | 72 months | |||
| SECONDARY | Rate of VGPR at 30 Months | 30 Months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Median Time to Response | 24 months | months | MEDIAN | |
| SECONDARY | Median Time to Major Response | 24 months | months | MEDIAN | |
| SECONDARY | Progression Free Survival (PFS) at 24 Months | 24 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression Free Survival (PFS) at 36 Months | 36 Months | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group10
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 Very Good Partial Response Within 24 Cycles of Therapy | Ibrutinib and Venetoclax | 19 | Participants | ||
| Number of Participants With Complete Response (CR) After 6 Cycles | Ibrutinib and Venetoclax | 0 | Participants | ||
| Number of Participants With Complete Response (CR) After 12 Cycles | Ibrutinib and Venetoclax | 0 | Participants | ||
| Number of Participants With Complete Response (CR) After 24 Cycles | Ibrutinib and Venetoclax | 0 | Participants | ||
| Rate of VGPR at 30 Months | Ibrutinib and Venetoclax | 9 | Participants | ||
| Median Time to Response | Ibrutinib and Venetoclax | 0.9 | 95% Confidence Interval 0.9 to 1 | months | |
| Median Time to Major Response | Ibrutinib and Venetoclax | 1.8 | 95% Confidence Interval 1.4 to 1.9 | months | |
| Progression Free Survival (PFS) at 24 Months | Ibrutinib and Venetoclax | 34 | Participants | ||
| Progression Free Survival (PFS) at 36 Months | Ibrutinib and Venetoclax | 21 | Participants | ||
| Number of Participants With Treatment Related Adverse Events as Assessed (CTCAE) Version 5.0 | Ibrutinib and Venetoclax | 45 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ibrutinib and Venetoclax | 45 | |
| Overall Study | COMPLETED | Ibrutinib and Venetoclax | 45 | |
| Overall Study | NOT COMPLETED | Ibrutinib and Venetoclax | 0 |
Source ClinicalTrials.gov
Adverse events132
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 | Anemia | Blood and lymphatic system disorders | Ibrutinib and Venetoclax | 8 | 45 | 8 |
| other | Easy bleeding | Blood and lymphatic system disorders | Ibrutinib and Venetoclax | 6 | 45 | 6 |
| other | Petechia | Blood and lymphatic system disorders | Ibrutinib and Venetoclax | 1 | 45 | 1 |
| other | Atrial Fibrillation | Cardiac disorders | Ibrutinib and Venetoclax | 3 | 45 | 3 |
| other | Chest pain | Cardiac disorders | Ibrutinib and Venetoclax | 3 | 45 | 3 |
| other | Palpitations | Cardiac disorders | Ibrutinib and Venetoclax | 9 | 45 | 9 |
| other | Blurred vision | Eye disorders | Ibrutinib and Venetoclax | 1 | 45 | 1 |
| other | Dry eye | Eye disorders | Ibrutinib and Venetoclax | 1 | 45 | 1 |
| other | Eye pain | Eye disorders | Ibrutinib and Venetoclax | 2 | 45 | 2 |
| other | Floaters | Eye disorders | Ibrutinib and Venetoclax | 1 | 45 | 1 |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ibrutinib and Venetoclax | 2 | 45 |
| Total, other adverse events | Ibrutinib and Venetoclax | 45 | 45 |
| Total, serious adverse events | Ibrutinib and Venetoclax | 10 | 45 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37971194 | 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 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/NCT04273139
GET https://conductscience.org/api/trials/v1/NCT04273139/events?page=2