Trial · NCT04329325
Blinatumomab and Tyrosine Kinase Inhibitor Therapy in People With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
NCT04329325, Phase 2, Active not recruiting, Memorial Sloan Kettering Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Blinatumomab and Tyrosine Kinase Inhibitor Therapy in People With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia. Trials, record NCT04329325. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04329325
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Blinatumomab and Tyrosine Kinase Inhibitor Therapy in People With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
- NCT number
- NCT04329325
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Acute Lymphoblastic Leukemia, Philadelphia Chromosome-Positive
- Interventions
- Blinatumomab, dasatinib, dexamethasone, methotrexate
- First posted
- 2020-04-01
- Last updated
- 2026-04-07
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of evaluable patients achieving complete molecular response | 7 months | (MRD negativity by flow cytometry and quantitative PCR of BCR-ABL transcripts) at any time during TKI + corticosteroid induction or consolidation with up to 3 cycles of blinatumomab in combination with TKI. |
| Secondary | Frequency, severity, and co-occurrence of treatment-related grade 3-4 toxicities | 13 months | assessed by NCI CTCAE v5.0 and rates of blinatumomab discontinuation due to toxicity among all patients beginning the consolidation portion of the study on dasatinib. The window for toxicity evaluation for this objective extends from the beginning of consolidation of the study until completion of maintenance or removal from study, whichever is sooner." |
| Secondary | Proportion of evaluable patients with CMR or molecular MRD positivity with MRD negativity by flow cytometry at any time during induction or consolidation. | 7 months | |
| Secondary | Duration of CMR among patients achieving MRD negativity after TKI + corticosteroid induction, followed by 1-3 cycles of blinatumomab in combination with an oral TKI. | 2 years | |
| Secondary | Cumulative incidence of morphologic and molecular relapse following consolidative therapy with blinatumomab in combination with an oral TKI | 2 years | |
| Secondary | Event-free survival following consolidative therapy with blinatumomab in combination with an oral TKI. | 2 years | |
| Secondary | Overall survival following consolidative therapy with blinatumomab in combination with an oral TKI. | 2 years | |
| Secondary | The proportion of patients first achieving CMR at any point during induction and proportion of patients not achieving CMR in Part 1 who subsequently achieved CMR at any point during consolidation. | 7 months | |
| Other | Frequency, type, and co-occurrence of ABL kinase mutations | 2 years | As assessed by sequencing of the ABL kinase gene in bone marrow or peripheral blood, observed in patients experiencing progression of B-ALL following consolidative therapy with blinatumomab in combination with an oral TKI. |
| Other | Frequency, type, and co-occurrence of new somatic mutations | 2 years | As assessed by next-generation sequencing of bone marrow or peripheral blood, in patients experiencing progression of B-ALL following consolidative therapy with blinatumomab in combination with an oral TKI. |
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/NCT04329325
GET https://conductscience.org/api/trials/v1/NCT04329325/registered