Trial · NCT03873493
A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia
NCT03873493, Phase 2, Completed, AbbVie; results first posted 2022-12-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia. Trials, record NCT03873493. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03873493
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia
- NCT number
- NCT03873493
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Leukemia, T-cell Prolymphocytic Leukemia (T-PLL), Cancer
- Interventions
- Venetoclax, Ibrutinib
- First posted
- 2019-03-13
- Last updated
- 2022-12-19
- Other registries' IDs
- eudract:2018-002179-17
- Results first posted
- 2022-12-19
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | Clinical response was assessed at Weeks 4, 8, 12, 16, and 24 for ORR assessment | ORR is defined as the percentage of participants achieving complete remission (CR), CR with incomplete bone marrow recovery (CRi), or partial remission (PR) as their best response per investigator assessment based on the T-PLL consensus criteria 2019. CR: All of the following response criteria must be met: Group A: * all lymph nodes \< 1 cm; * spleen \< 13 cm; * no constitutional symptoms; * circulating lymphocyte count \< 4 × 10\^9/L; * bone marrow T-PLL cells \< 5% of mononuclear cells; * no other specific site involvement Group B: * platelets ≥ 100 × 10\^9 /L; * hemoglobin ≥ 11.0 g/dL; * neutrophils ≥ 1.5 × 10\^9 /L. CRi: All of the CR response criteria in Group A met; at least 1 parameter in Group B not achieved, unrelated to T-PLL, but related to drug toxicity. PR: At least 2 of the parameters in Group A and 1 parameter in Group B need to improve if previously abnormal. If only 1 parameter of both Groups A and B is abnormal prior to therapy, only 1 parameter needs to improve. |
| Secondary | Progression-Free Survival (PFS) | From first dose of study drug to end of study; median time on study was 30.1 weeks. | Progression-free survival is defined as the time from the date of first dose of any study drug to the date of earliest disease progression or death. PFS was calculated using Kaplan-Meier methods. Response was assessed by the investigator based on the T-PLL consensus criteria 2019. Progressive disease (PD) is defined as meeting at least one of the criteria of Group A or Group B below: Group A: * lymph nodes increase in \> 20% in sum of long-axis diameters of up to 3 target lesions (SLD) from nadir; * spleen increase ≥ 50% in vertical length beyond normal from baseline; * circulating lymphocyte count increase ≥ 50% from baseline; * appearance of a new lesion; Group B: * platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity); * hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL; * neutrophils decrease of ≥ 50% from baseline due to T-PLL. |
| Secondary | Duration of Response (DOR) | From first dose of study drug to end of study; median time on study was 30.1 weeks. | Duration of response is defined for participants who achieved a best overall response of CR, CRi, or PR as the time from the date of first response (CR, CRi, or PR) to the earliest date of disease progression or death. DOR was calculated using Kaplan-Meier methods. Response was assessed by the investigator based on the T-PLL consensus criteria 2019. Progressive disease is defined as meeting at least one of the criteria of Group A or Group B below: Group A: * lymph nodes increase in \> 20% in SLD from nadir; * spleen increase ≥ 50% in vertical length beyond normal from baseline; * circulating lymphocyte count increase ≥ 50% from baseline; * appearance of a new lesion; Group B: * platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity); * hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL; * neutrophils decrease of ≥ 50% from baseline due to T-PLL. |
| Secondary | Time to Progression (TTP) | From first dose of study drug to end of study; median time on study was 30.1 weeks. | Time to progression is defined as the time from the date of the participant's first dose of any study drug to the date of earliest disease progression. TTP was calculated using Kaplan-Meier methods. Clinical response (laboratory and physical examination assessments) was assessed by the investigator according to the T-PLL consensus criteria 2019. Progressive disease is defined as meeting at least one of the criteria of Group A or Group B below: Group A: * lymph nodes increase in \> 20% in SLD from nadir; * spleen increase ≥ 50% in vertical length beyond normal from baseline; * circulating lymphocyte count increase ≥ 50% from baseline; * appearance of a new lesion; Group B: * platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity); * hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL; * neutrophils decrease of ≥ 50% from baseline due to T-PLL. |
| Secondary | Event-free Survival (EFS) | From first dose of study drug to end of study; median time on study was 30.1 weeks. | Event-free survival is defined as time from participant's first dose of any study drug to the date of earliest disease progression, death, or start of a new anti-T-PLL therapy. EFS was calculated using Kaplan-Meier methods. Clinical response (laboratory and physical examination assessments) was assessed by the investigator according to the T-PLL consensus criteria 2019. Progressive disease is defined as meeting at least one of the criteria of Group A or Group B below: Group A: * lymph nodes increase in \> 20% in SLD from nadir; * spleen increase ≥ 50% in vertical length beyond normal from baseline; * circulating lymphocyte count increase ≥ 50% from baseline; * appearance of a new lesion; Group B: * platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity); * hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL; * neutrophils decrease of ≥ 50% from baseline due to T-PLL. |
| Secondary | Disease Control Rate (DCR) | Clinical response was assessed at Weeks 4, 8, 12, 16, and 24 for DCR assessment | DCR is defined as the percentage of participants who achieved CR, CRi, PR, or stable disease (SD) as best overall response per investigator assessment based on the T-PLL consensus criteria 2019. Stable disease is defined as meeting all of the following criteria for at least 3 months: * lymph nodes change of -29% to +20% in SLD; * spleen change of -49% to +49% beyond normal from baseline; * circulating lymphocyte count \> 30 × 10\^9 /L or change of -49% to +49%; * platelet count change of -49% to +49%; * hemoglobin \< 11.0 g/dL or change \< 50% from baseline or change \< 2 g/dL; * neutrophils change of -49% to +49%. |
| Secondary | Overall Survival (OS) | From first dose of study drug to end of study; median time on study was 30.1 weeks. | Overall survival is defined as the time from the date of the participant's first dose of any study drug to death from any cause. OS was calculated using Kaplan-Meier methods. |
| Secondary | Number of Eligible Participants Reaching Autologous or Allogeneic Transplantation | From first dose of study drug to end of study; median time on study was 30.1 weeks. | Participants eligible for autologous or allogeneic transplantation were transplant-naïve participants who achieved CR. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAE) | From first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks) | An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are any event with onset after the first dose of study drug and no more than 30 days after the last dose of study drug. A serious AE was an event that resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity, or an important medical event requiring medical or surgical intervention to prevent a serious outcome. The Investigator rated the severity of each AE according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening and grade 5 = death. The Investigator assessed the relationship of the AE to the use of study drug. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | Clinical response was assessed at Weeks 4, 8, 12, 16, and 24 for ORR assessment | The full analysis set includes all participants who received at least 1 dose of study drug (either venetoclax or ibrutinib). | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | From first dose of study drug to end of study; median time on study was 30.1 weeks. | Full analysis set | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) | From first dose of study drug to end of study; median time on study was 30.1 weeks. | Full analysis set participants with a best overall response of CR, CRi, or PR | months | MEDIAN |
| SECONDARY | Time to Progression (TTP) | From first dose of study drug to end of study; median time on study was 30.1 weeks. | Full analysis set | months | MEDIAN |
| SECONDARY | Event-free Survival (EFS) | From first dose of study drug to end of study; median time on study was 30.1 weeks. | Full analysis set | months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | Clinical response was assessed at Weeks 4, 8, 12, 16, and 24 for DCR assessment | Full analysis set | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From first dose of study drug to end of study; median time on study was 30.1 weeks. | Full analysis set | months | MEDIAN |
| SECONDARY | Number of Eligible Participants Reaching Autologous or Allogeneic Transplantation | From first dose of study drug to end of study; median time on study was 30.1 weeks. | Participants who were transplant-naive and achieved CR. No participants achieved a CR to be eligible for transplant. | ||
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAE) | From first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks) | All participants who received at least 1 dose of study drug (either venetoclax or ibrutinib) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | Venetoclax + Ibrutinib | 7.1 | 95% Confidence Interval 0.2 to 33.9 | percentage of participants | |
| Progression-Free Survival (PFS) | Venetoclax + Ibrutinib | 2.7 | 95% Confidence Interval 1.2 to 5.3 | months | |
| Duration of Response (DOR) | Venetoclax + Ibrutinib | 4.6 | Full Range 4.6 to 4.6 | months | |
| Time to Progression (TTP) | Venetoclax + Ibrutinib | 2.7 | 95% Confidence Interval 1.2 to 5.3 | months | |
| Event-free Survival (EFS) | Venetoclax + Ibrutinib | 2.6 | 95% Confidence Interval 0.6 to 5.3 | months | |
| Disease Control Rate (DCR) | Venetoclax + Ibrutinib | 28.6 | 95% Confidence Interval 8.4 to 58.1 | percentage of participants | |
| Overall Survival (OS) | Venetoclax + Ibrutinib | 7.3 | 95% Confidence Interval 1.6 to 10.9 | months | |
| Number of Participants With Treatment-emergent Adverse Events (TEAE) | Venetoclax + Ibrutinib | Any adverse event | 14 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAE) | Venetoclax + Ibrutinib | AE with NCI-CTCAE toxicity Grade 3, 4, or 5 | 11 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAE) | Venetoclax + Ibrutinib | Serious adverse event | 8 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Venetoclax + Ibrutinib | 14 | |
| Overall Study | COMPLETED | Venetoclax + Ibrutinib | 0 | |
| Overall Study | NOT COMPLETED | Venetoclax + Ibrutinib | 14 |
Source ClinicalTrials.gov
Adverse events105
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 | Venetoclax + Ibrutinib | 3 | 14 | 4 |
| other | FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | Venetoclax + Ibrutinib | 1 | 14 | 1 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Venetoclax + Ibrutinib | 1 | 14 | 1 |
| other | ATRIAL FIBRILLATION | Cardiac disorders | Venetoclax + Ibrutinib | 1 | 14 | 1 |
| other | TACHYCARDIA | Cardiac disorders | Venetoclax + Ibrutinib | 1 | 14 | 1 |
| other | HYPOACUSIS | Ear and labyrinth disorders | Venetoclax + Ibrutinib | 1 | 14 | 1 |
| other | MIDDLE EAR EFFUSION | Ear and labyrinth disorders | Venetoclax + Ibrutinib | 1 | 14 | 1 |
| other | ANDROGEN DEFICIENCY | Endocrine disorders | Venetoclax + Ibrutinib | 1 | 14 | 1 |
| other | EYE SWELLING | Eye disorders | Venetoclax + Ibrutinib | 1 | 14 | 1 |
| other | LACRIMATION INCREASED | Eye disorders | Venetoclax + Ibrutinib | 1 | 14 | 1 |
1 to 10 of 105Source ClinicalTrials.gov
See all 105 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Venetoclax + Ibrutinib | 10 | 14 |
| Total, other adverse events | Venetoclax + Ibrutinib | 14 | 14 |
| Total, serious adverse events | Venetoclax + Ibrutinib | 8 | 14 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT03873493
GET https://conductscience.org/api/trials/v1/NCT03873493/results?page=2