Trial · NCT03181126
A Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma
NCT03181126, Phase 1, Completed, AbbVie
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma. Trials, record NCT03181126. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03181126
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma
- NCT number
- NCT03181126
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 69 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Acute Lymphoblastic Leukemia (ALL), Lymphoblastic Lymphoma
- Interventions
- Navitoclax, Chemotherapy, Venetoclax
- First posted
- 2017-06-08
- Last updated
- 2021-10-14
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cmax of Venetoclax + Navitoclax | Up to approximately 9 months | Maximum observed plasma concentration (Cmax) of venetoclax + navitoclax |
| Primary | AUC of Venetoclax + Navitoclax | Up to approximately 9 months | Area under the plasma concentration-time curve (AUC) of venetoclax + navitoclax |
| Primary | Tmax of Venetoclax + Navitoclax | Up to approximately 9 months | Time to Cmax (Tmax) of Venetoclax + Navitoclax |
| Primary | CL/F of Venetoclax + Navitoclax | Up to approximately 9 months | Apparent oral clearance (CL/F) of venetoclax + navitoclax |
| Primary | Number of participants with dose-limiting toxicities (DLT) | Up to approximately 28 days after initial dose of study drug | A DLT is any Grade 3 or higher non-hematologic adverse event (AE) with exceptions outlined in the protocol. AEs and toxicities that occur beyond the DLT assessment period will also be evaluated by the investigator and AbbVie and may be considered as dose-limiting. |
| Secondary | Progression-free survival (PFS) | Up to 9 months after the last subject has enrolled into the study | PFS is defined as the number of days from the date of enrollment to the date of earliest disease progression or death. |
| Secondary | Partial Response (PR) rate | Up to 9 months after the last subject has enrolled into the study | PR defined as no peripheral blasts or peripheral blood absolute blast count decreased by ≥ 50% from baseline, bone marrow with 5 - 25% blasts and at least a 50% decrease in bone marrow blast percent from baseline, no evidence of extramedullary disease. |
| Secondary | Number of Participant who Proceed to Stem Cell Transplantation or Chimeric antigen receptor T-cell (CAR-T) Therapy | Up to 9 months after the last subject has enrolled into the study | Determine the number of participants who proceed to stem cell transplantation or CAR-T therapy. |
| Secondary | Overall survival (OS) | Up to 9 months after the last subject has enrolled into the study | OS is defined as the number of days from the date of enrollment to the date of death. |
| Secondary | Objective response rate (ORR) | Up to 9 months after the last subject has enrolled into the study | The proportion of subjects with objective response rate (complete response \[CR\] + CR incomplete recovery \[CRi\] + CR without platelet recovery \[CRp\]) for ALL subjects and (CR+PR) for LL subjects. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39368878 | 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/NCT03181126
GET https://conductscience.org/api/trials/v1/NCT03181126/registered