Trial · NCT07914166
Asciminib-Based Induction Therapy for the Treatment of Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
NCT07914166, Phase 1, Not yet recruiting, City of Hope Medical Center
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Asciminib-Based Induction Therapy for the Treatment of Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia. Trials, record NCT07914166. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07914166
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Asciminib-Based Induction Therapy for the Treatment of Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
- NCT number
- NCT07914166
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 21 participants, estimated
- Lead sponsor
- City of Hope Medical Center
- Conditions
- B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
- Interventions
- Asciminib, Biospecimen Collection, Blinatumomab, Bone Marrow Aspiration, Corticosteroid, Cytarabine, Dexamethasone, Echocardiography Test, Methotrexate, Vincristine
- First posted
- 2026-11-03
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of dose limiting toxicity (DLT) | Up to 2 cycles (Cycle length = 28 days) | Toxicity will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE), version (v) 6.0. |
| Primary | Maximum tolerated dose/recommended phase 2 dose | Up to the 18.6 months | Will be established using a phase 1 queue 3+3 design. |
| Secondary | Incidence of adverse events (AEs) | Up to 30 days after last dose of study drug | The number and percent of patients with AEs will be tabulated by system organ class and preferred term using the Medical Dictionary for Regulatory Activities preferred term dictionary. Observed toxicities will be summarized for the DLT period (cycles 1 and 2), as well as for each of the 3 cycles, in terms of type (organ affected or laboratory determination), severity, time of onset, duration, frequency, probable association with each study treatment and reversibility or outcome. Listings and narratives will be provided for deaths on study, DLTs/unacceptable toxicities, serious adverse events, and events leading to discontinuation of treatment. Descriptive summaries will also be generated for AE data assessed and graded according to the CTCAE v6.0 grading system. |
| Secondary | Complete molecular response | At the completion of cycle 1 (Cycle length = 28 days) and cycle 3 (Cycle length = 42 days) | Will be assessed in accordance with the 2025 National Comprehensive Cancer Network (NCCN) guidelines at each dose level and disease assessment timepoint (cycles 1 and 3). Rates and 95% Clopper-Pearson binomial confidence interval (CI) will be calculated. |
| Secondary | Complete response (CR)/CR with incomplete hematologic recovery | At the completion of cycle 1 (Cycle length = 28 days) and cycle 3 (Cycle length = 42 days) | Will be assessed in accordance with the 2025 NCCN guidelines at each dose level and disease assessment timepoint (cycles 1 and 3). Rates and 95% Clopper-Pearson binomial CI will be calculated. |
| Secondary | Minimal residual disease negativity | At the completion of cycle 1 (Cycle length = 28 days) and cycle 3 (Cycle length = 42 days) | Will be assessed in accordance with the 2025 NCCN guidelines at each dose level and disease assessment timepoint (cycles 1 and 3). Rates and 95% Clopper-Pearson binomial CI will be calculated. |
| Secondary | Rate of allogeneic hematopoietic cell transplantation | Up to 1 cycle (Cycle length = 28 days) | Rates and 95% Clopper-Pearson binomial CI will be calculated. |
| Secondary | Overall survival (OS) | From first study dose to death from any cause or last contact date, whichever comes first, assessed up to 1 year | Median OS and 1-year OS rate, will be estimated using the product-limit method of Kaplan-Meier product-limit method and the 95% C.I. of the survival curve will be calculated by the Brookmeyer-Crowley method with log-log transformation. |
| Secondary | Progression-free survival (PFS) | Up to 1 year | Median PFS and 1-year PFS rate, will be estimated using the product-limit method of Kaplan-Meier product-limit method and the 95% C.I. of the survival curve will be calculated by the Brookmeyer-Crowley method with log-log transformation. |
| Secondary | Concentration of asciminib (Pharmacokinetics) | Up to 98 days (Cycle 1 and 2 are 28 days each, Cycle 3 is 42 days) | Will be assessed over time by descriptive and graphical statistics. |
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/NCT07914166
GET https://conductscience.org/api/trials/v1/NCT07914166/registered