Trial · NCT06918431
Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
NCT06918431, Phase 2, Recruiting, City of Hope Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma. Trials, record NCT06918431. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06918431
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
- NCT number
- NCT06918431
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 53 participants, estimated
- Lead sponsor
- City of Hope Medical Center
- Conditions
- B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative, Lymphoblastic Lymphoma
- Interventions
Asparaginase Erwinia chrysanthemi, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Cyclophosphamide, Cytarabine, Cytarabine, Daunorubicin Hydrochloride, Dexamethasone, Echocardiography, Lumbar Puncture, Mercaptopurine, Methotrexate, Positron Emission Tomography, Rituximab, Vincristine Sulfate
- First posted
- 2025-04-09
- Last updated
- 2026-10-13
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of adverse events (AEs) (Safety Lead-in) | Up to completion of induction cycle (cycle length = 28 days) | Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Will be summarized for evaluable patients in terms of type (organ affected or laboratory determination), severity, time of onset, duration, frequency, probable association with the study treatment and reversibility or outcome. |
| Primary | Incidence of unacceptable adverse events (Safety Lead-in) | Up to completion of induction cycle 1 (cycle length = 28 days) | Will be summarized for evaluable patients in terms of type (organ affected or laboratory determination), severity, time of onset, duration, frequency, probable association with the study treatment and reversibility or outcome. |
| Primary | Incidence of grade 3 or higher hepatotoxicity and not resolved to grade 1 or lower within 14 days of occurrence (Expansion) | Up to completion of induction (cycle length = 28 days) | Will be graded using NCI CTCAE v 5.0. Will be summarized for evaluable patients in terms of type (organ affected or laboratory determination), severity, time of onset, duration, frequency, probable association with the study treatment and reversibility or outcome. The overall rate and its 95% Clopper Pearson binomial confidence interval (CI) will be estimated. |
| Secondary | Incidence of AEs (Expansion cohort only) | Up to completion of induction (cycle length = 28 days) | Will be graded according to NCI CTCAE v 5.0. Will be summarized for evaluable patients in terms of type (organ affected or laboratory determination), severity, time of onset, duration, frequency, probable association with the study treatment and reversibility or outcome. |
| Secondary | Composite complete response (CR) | After induction with or without extended induction (induction cycle length = 28 days, extended induction cycle length = 16 days) | Will be defined as CR and CR with incomplete hematologic recovery. The overall rate and its 95% Clopper Pearson binomial confidence interval (CI) will be estimated. |
| Secondary | CR rate | After induction with or without extended induction (induction cycle length = 28 days, extended induction cycle length = 16 days) | The overall rate and its 95% Clopper Pearson binomial confidence interval (CI) will be estimated. |
| Secondary | Minimal residual disease (MRD) negativity | After induction with or without extended induction (induction cycle length = 28 days, extended induction cycle length = 16 days), at day 28 +/- 42 | Will be defined as residual leukemia \< 0.01% by flow cytometry and/or clonoSEQ. The overall rate and its 95% Clopper Pearson binomial confidence interval (CI) will be estimated. |
| Secondary | MRD negativity | After consolidation (consolidation cycle length = 8 weeks) | The overall rate and its 95% Clopper Pearson binomial confidence interval (CI) will be estimated. |
| Secondary | Proportion of patients to receive extended induction/consolidation/salvage therapy | Within 42 days from initiating induction | The overall rate and its 95% Clopper Pearson binomial confidence interval (CI) will be estimated. |
| Secondary | Incidence of grade 3 or higher hepatotoxicity | During induction (cycle length = 28 days) | The overall rate and its 95% Clopper Pearson binomial confidence interval (CI) will be estimated. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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.
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/NCT06918431
GET https://conductscience.org/api/trials/v1/NCT06918431/registered