Trial · NCT02296918
Acalabrutinib in Combination With Anti-CD20 and Venetoclax in Relapsed/Refractory or Untreated CLL/SLL/PLL
NCT02296918, Phase 1, Completed, Acerta Pharma BV
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Acalabrutinib in Combination With Anti-CD20 and Venetoclax in Relapsed/Refractory or Untreated CLL/SLL/PLL. Trials, record NCT02296918. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02296918
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Acalabrutinib in Combination With Anti-CD20 and Venetoclax in Relapsed/Refractory or Untreated CLL/SLL/PLL
- NCT number
- NCT02296918
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 69 participants, actual
- Lead sponsor
- Acerta Pharma BV
- Conditions
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia
- Interventions
- acalabrutinib, Obinutuzumab, Venetoclax, Rituximab
- First posted
- 2014-11-21
- Last updated
- 2025-12-19
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Objective Response (OR) at 12 Months as Assessed by the Investigator in Cohorts 1 and 2 | Day 1 through 12 months | The OR is complete remission (CR), incomplete CR (CRi), nodular partial remission (nPR), or partial remission (PR) for at least 2 months. For CLL, CR:lymphocytes (lympho) \<4×10\^9/L, normocellular bone marrow (BM) \<30% lympho, no B-lymphoid nodules, normal lymph nodes (NLN), liver and spleen (L/S), absolute neutrophils (ANC) \>1.5×10\^9/L, platelets \>100×10\^9/L, hemoglobin (Hb) \>11g/dL; CRi: lympho \<4×10\^9/L, hypocellular BM, NLN, L/S, persistent anemia/thrombocytopenia/neutropenia; nPR: CR with present lymphoid nodules (NL); PR: \>=50% reduction in lymphadenopathy and/or enlargement of L/S or lympho (\<5×10\^9/L or \>=50% decrease from baseline), criteria of ANC/platelets/Hb per CR or \>=50% improvement over baseline. Hematology without exogenous growth factors/transfusion. For SLL, CR: no disease/disease-related symptoms, normal/\<=1cm LN, no enlargement of L/S/NL, disease-free BM; PR: \>=50% decrease in dominant masses with no size increase/new lesions, and \>=50% reduction of nodules in S/L. |
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in all Cohorts | Day 1 through the final data cutoff date (approximately 6 years 8 months) | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. |
| Primary | Number of Participants With Treatment-Emergent Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 Abnormalities in Laboratory Parameters in all Cohorts | Day 1 through the final data cutoff date (approximately 6 years 8 months) | Participants with treatment-emergent CTCAE Grade 3 or 4 abnormalities in laboratory parameters are reported. Laboratory analysis included hematology, clinical chemistry, and immunology. |
| Primary | Number of Participants With Abnormal Vital Signs Reported as TEAEs in all Cohorts | Day 1 through the final data cutoff date (approximately 6 years 8 months) | Participants with abnormal vital signs (blood pressure, respiratory rate, heart rate, temperature, and body weight) reported as TEAEs are reported. |
| Primary | Number of Participants with Shift From Baseline to Worst (Grade 3 and 4) Post-baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status in all Cohorts | Baseline (Days -28 to -1) through the final data cutoff date (approximately 6 years 8 months) | The ECOG Performance Status assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (\>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair \>50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=death. Shift from baseline (Days -28 to -1) to worst Grade 3 and/4 in EOCG status are reported. |
| Secondary | Percentage of Participants with CR as Assessed by the Investigator in all Cohorts | Day 1 through the final data cutoff date (approximately 6 years 8 months) | For CLL, CR: lymphocytes \< 4×10\^9/L, normocellular bone marrow \< 30% lymphocytes, no B-lymphoid nodules, normal lymph nodes, liver and spleen, absolute neutrophils \> 1.5×10\^9/L, platelets \> 100×10\^9/L, hemoglobin \> 11g/dL. Hematology without exogenous growth factors/ transfusion. For SLL, CR: no disease/disease-related symptoms, normal/\<=1 cm lymph nodes, no enlargement of liver/spleen/lymphoid nodules, disease-free bone marrow. |
| Secondary | Percentage of Participants With Minimal Residual Disease (MRD)-negative CR as Assessed by the Investigator in all Cohorts | Day 1 through the final data cutoff date (approximately 6 years 8 months) | For CLL, CR: lymphocytes \<4×10\^9/L, normocellular bone marrow (BM) \<30% lymphocytes, no B-lymphoid nodules, normal lymph nodes, liver, and spleen, absolute neutrophil count \>1.5×10\^9/L, platelets \>100×10\^9/L, hemoglobin \> 11g/dL; CRi: lymphocytes \< 4×10\^9/L, hypocellular BM, normal lymph nodes, liver, and spleen, persistent anemia/thrombocytopenia/neutropenia. Hematology without exogenous growth factors/transfusion. For SLL, CR: no disease/disease-related symptoms, normal/\<=1 cm lymph nodes, no enlargement of liver/spleen/lymphoid nodules, disease-free BM. MRD negativity was determined in bone marrow by flow cytometry. |
| Secondary | Percentage of Participants With OR at Cycle 16 as Assessed by the Investigator in Cohorts 3 and 4 | Day 1 to the end of Cycle 16 (each cycle is 28 days) | The OR is complete remission (CR), incomplete CR (CRi), nodular partial remission (nPR), or partial remission (PR) for at least 2 months. For CLL, CR: lymphocytes \<4×10\^9/L, normocellular bone marrow \<30% lymphocytes, no B-lymphoid nodules, normal lymph nodes (NLN), liver and spleen (L/S), absolute neutrophils (ANC) \>1.5×10\^9/L, platelets \>100×10\^9/L, hemoglobin (Hb) \>11g/dL; CRi: lymphocytes \<4×10\^9/L, hypocellular bone marrow, NLN, L/S, persistent anemia/thrombocytopenia/neutropenia; nPR: CR with present lymphoid nodules; PR: \>=50% reduction in lymphadenopathy and/or enlargement of L/S or lymphocytes (\<5×10\^9/L or \>=50% decrease from baseline), criteria of ANC/platelets/Hb per CR or \>=50% improvement over baseline. Hematology without exogenous growth factors/transfusion. |
| Secondary | Duration of Response (DoR) as Assessed by the Investigator in all Cohorts | Day 1 through the final data cutoff date (approximately 6 years 8 months) | The DoR is defined as the time from the date of achieving the first CR, CRi, nPR, or PR (PR or better) to the date of progressive disease (PD) or death due to any cause, whichever occurred first. The CR, CRi, nPR, and PR are defined in the above outcome measure. For CLL, PD is defined as any one of the criteria: lymphocytes \>=50% increase from baseline, appearance of any new lesion or new hepatomegaly or splenomegaly or \>= 50% increase in lymphadenopathy/hepatomegaly/splenomegaly, decrease of Hb levels \>2 g/dL or to \<10 g/dL, or decrease of platelets \>50% or to\<100,000/μL. For SLL, PD is defined as any one of the criteria: appearance of a new lesion \>1.5 cm in any axis; \>=50% increase in the products of at least 2 LNs; \>=50% increase in the longest diameter of a previously identified node \>1 cm in short axis; \>=50% increase in the size of the L and/or S or previously determined nodules in the L/S; or new or recurrent BM involvement. The DoR was estimated using Kaplan-Meier method. |
| Secondary | Progression Free Survival (PFS) as Assessed by the Investigator in all Cohorts | Day 1 through the final data cutoff date (approximately 6 years 8 months) | The PFS is defined as the time from the date of first dose of study drug to the date of first PD or death due to any cause, whichever occurred first. For CLL, PD is defined as any one of the criteria as: lymphocytes \>=50% increase from baseline, appearance of any new lesion or new appearance of hepatomegaly or splenomegaly or \>= 50% increase in lymphadenopathy/hepatomegaly/splenomegaly, decrease of Hb levels \>2 g/dL or to \<10 g/dL, or decrease of platelets \>50% or to\<100,000/μL. For SLL, PD is defined as any one of the criteria as: appearance of a new lesion \>1.5 cm in any axis; \>=50% increase in the products of at least 2 LNs; \>=50% increase in the longest diameter of a previously identified node \>1 cm in short axis; \>=50% increase in the size of the L and/or S or previously determined nodules in the L/S; or new or recurrent BM involvement. The PFS was estimated using Kaplan-Meier method. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
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 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/NCT02296918
GET https://conductscience.org/api/trials/v1/NCT02296918/registered?page=2