Trial · NCT07133997
Recombinant Erwinia Asparaginase and Venetoclax in Combination With Blinatumomab for the Treatment of Relapsed or Refractory CD19 Positive B-cell Acute Lymphoblastic Leukemia
NCT07133997, Phase 1, Recruiting, City of Hope Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Recombinant Erwinia Asparaginase and Venetoclax in Combination With Blinatumomab for the Treatment of Relapsed or Refractory CD19 Positive B-cell Acute Lymphoblastic Leukemia. Trials, record NCT07133997. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07133997
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Recombinant Erwinia Asparaginase and Venetoclax in Combination With Blinatumomab for the Treatment of Relapsed or Refractory CD19 Positive B-cell Acute Lymphoblastic Leukemia
- NCT number
- NCT07133997
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 26 participants, estimated
- Lead sponsor
- City of Hope Medical Center
- Conditions
- Recurrent B Acute Lymphoblastic Leukemia, Refractory B Acute Lymphoblastic Leukemia
- Interventions
Asparaginase Erwinia chrysanthemi, Biospecimen Collection, Blinatumomab, Bone Marrow Aspiration, Bone Marrow Biopsy, Cyclophosphamide, Echocardiography Test, Lumbar Puncture, Multigated Acquisition Scan, Venetoclax, Vincristine
- First posted
- 2025-08-21
- Last updated
- 2026-10-16
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of adverse events (AEs) (Phase I) | Up to 30 days after last dose of study treatment | Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Will be summarized in terms of type (organ affected or laboratory determination), severity, attribution, time of onset, duration, probable association with the study treatment and reversibility or outcome by counts/ rates and 95% Clopper Pearson confidence interval (CI). |
| Primary | Dose-limiting toxicities (DLT) (Phase I) | From the start of therapy (day 1) through the end of the first cycle (day 49) | Will be graded according to NCI CTCAE v 5.0. Will be summarized in terms of type (organ affected or laboratory determination), severity, attribution, time of onset, duration, probable association with the study treatment and reversibility or outcome by counts/ rates and 95% Clopper Pearson CI. |
| Primary | Maximum tolerated schedule (Phase I) | During cycle 1 (cycle length = 49 days) | Will be based on the assessment of DLT during cycle 1. |
| Primary | Recommended phase 2 schedule (Phase 1) | After cycle 1 (cycle length = 49 days) | Will be selected based on maximum tolerated schedule and a review of cumulative toxicity and tolerability data after cycle 1 and may be lower than the maximum tolerated schedule. |
| Primary | Best response (Expansion Phase) | Up to 30 days after last dose of study treatment | The 95% Clopper Pearson binomial CI will be calculated. |
| Secondary | Composite remission rate | At end of cycle 1 (cycle length = 49 days) | The complete remission (CR)/CR with incomplete recovery/CR with partial hematologic recovery and 95% Clopper Pearson binomial CI will be calculated. |
| Secondary | Minimal residual disease negativity | At the end of each cycle (cycle 1 length = 49 days, cycle 2 length = 42 days) | Will be defined as residual leukemia \< 0.01% by flow cytometry or Clonoseq in bone marrow biopsy. Clopper Pearson binomial CI will be calculated. |
| Secondary | Incidence of adverse events (Expansion Phase) | Up to 30 days after last dose of study treatment | Will be graded according to NCI CTCAE v 5.0. Will be summarized in terms of type (organ affected or laboratory determination), severity, attribution, time of onset, duration, probable association with the study treatment and reversibility or outcome by counts/ rates and 95% Clopper Pearson CI. |
| Secondary | Patients who bridge to transplant directly from the trial therapy | Up to 30 days after last dose of study treatment | The Clopper Pearson binomial CI will be calculated. |
Source ClinicalTrials.gov
Outcomes0
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA033572 | Cancer Center Support Grant | CARPTEN, JOHN D. | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT07133997
GET https://conductscience.org/api/trials/v1/NCT07133997/registered