Trial · NCT04845035
Pediatric-Inspired Chemotherapy Plus Tyrosine Kinase Inhibitor in Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
NCT04845035, Phase 2, Withdrawn, University of Michigan Rogel Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pediatric-Inspired Chemotherapy Plus Tyrosine Kinase Inhibitor in Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia. Trials, record NCT04845035. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04845035
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pediatric-Inspired Chemotherapy Plus Tyrosine Kinase Inhibitor in Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
- NCT number
- NCT04845035
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Conditions
- Acute Lymphoblastic Leukemia
- Interventions
- Dasatinib, Ponatinib, Berlin-Frankfurt-Münster Chemotherapy, Methotrexate and Cytarabine
- First posted
- 2021-04-14
- Last updated
- 2024-02-22
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of complete molecular remission (CMR) at the end of one cycle of Dasatinib + BFM | Post day 36; up to day 43 | CMR will be assessed by minimal residual disease (MRD)-negative status, using quantitative reverse transcription-polymerase chain reaction (RT-qPCR) analysis from bone marrow aspirates, after 1 cycle of induction therapy with Berlin-Frankfurt-Münster (BFM) protocol and Dasatinib. |
| Secondary | Rate of Adverse Events related to Dasatinib and Ponatinib | 30 days after last treatment, up to approximately 3 years | Per NCI CTCAE v5.0 toxicity data, specifically: * for dasatinib: pulmonary hypertension (any grade) or grade ≥ 3 serositis/volume overload. * for ponatinib: arterial embolism (any grade) and grade ≥ 3 venous thromboembolism, heart failure, or pancreatitis |
| Secondary | Percentage of participants who begin ponatinib post-induction that complete at least one cycle. | At 18 weeks | Feasibility will be assessed by the percentage, among patients who begin the ponatinib post-induction regimen, that complete at least one cycle. Completion is defined as the ability to tolerate ≥ 80% dose intensity of all prescribed anti-cancer agents per cycle of ponatinib initiated. |
| Secondary | Complete hematologic (morphologic) remission (CHR) rate after induction | After Remission Induction Phase I and at end of study treatment, up to approximately 3 years | Bone marrow assessed by morphologic review of both the aspirate smear and core biopsy |
| Secondary | Complete cytogenic remission (CCyR) rate post induction | After Remission Induction Phase I and at end of study treatment, up to approximately 3 years | Bone marrow aspirate assessed by karyotype and/or fluorescence in situ hybridization (FISH). |
| Secondary | Complete molecular remission (CMR) rate | After Remission Induction Phase I and at end of study treatment, up to approximately 3 years | Bone marrow aspirate analyzed by RT-qPCR. |
| Secondary | Disease-free survival (DFS) | up to five years after end of study treatment (approximately 8 years) | Disease-Free Survival (DFS) is defined as the duration of time from attainment of CR (morphologic remission, hematologic remission, etc) to Morphologic Relapse (Relapsed Disease) or Death. |
| Secondary | Overall survival (OS). | up to five years after end of study treatment (approximately 8 years) | Overall Survival (OS) is defined as the length of time from the date of diagnosis that patients diagnosed with the disease are still alive. |
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.
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/NCT04845035
GET https://conductscience.org/api/trials/v1/NCT04845035/registered