Trial · NCT07301424
Subcutaneous Blinatumomab Plus Ponatinib for BCR-ABL+ B-ALL
NCT07301424, Phase 2, Not yet recruiting, University of Alberta
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Subcutaneous Blinatumomab Plus Ponatinib for BCR-ABL+ B-ALL. Trials, record NCT07301424. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07301424
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Subcutaneous Blinatumomab Plus Ponatinib for BCR-ABL+ B-ALL
- NCT number
- NCT07301424
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 80 participants, estimated
- Lead sponsor
- University of Alberta
- Conditions
- Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+), BCR-ABL Positive Acute Lymphoblastic Leukemia
- Interventions
- Treatment with blinatumomab given subcutaneously.
- First posted
- 2025-12-24
- Last updated
- 2026-08-12
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | • MR4 rate for BCR-ABL1 by PCR after 2 cycles of blinatumomab | At end of cycle 2 of blinatumomab (each cycle is 28 days). | After 2 cycles of blinatumomab, the bone marrow will be tested for MRD by PCR for BCR-ABL. The rate of MRD4 (MRD\<10\[-4\]) at this timepoint will constitute a primary outcome. |
| Primary | Complete molecular response (CMR) by IgR (Clonoseq[R]) after 2 cycles of blinatumomab. | At end of cycle 2 of Blinatumomab (each cycle being 28 days). | After 2 cycles of Blinatumomab the marrow will be tested for MRD by Clonoseq. The rate of MRD negativity by IgR will constitute a primary outcome. |
| Secondary | Complete response rate | Determined at the end of the 70 day induction phase | Complete response rate (CR and CRh) of ponatinib + prednisone |
| Secondary | Patient and caregiver experience | At screening, end of induction (Day 70), end of cycles 2 and 5 of blinatumomab, and one year after start of maintenance therapy with ponatinib. | EORTC QLQ-C30 scores |
| Secondary | Molecular response duration | From the time of documented remission at Day 70 of induction, until the date of first documented molecular progression, assessed up to 5 years from the start of treatment. | The duration of MR4 by PCR and CMR by Clonoseq will be determined in follow-up bone marrow assessments. |
| Secondary | Relapse-free survival (RFS) | From the date of documented remission at day 70 until the date of first documented relapse or date of death from any cause, whichever came first, assessed up to 5 years from the start of treatment. | Time from primary outcome to molecular disease progression. |
| Secondary | Overall survival (OS) | From the date of enrollment until the date of death from any cause or last follow-up, assessed up to 5 years from the start of treatment. | Time from start of treatment until death form any cause or last follow-up. |
| Secondary | Safety and tolerability | From the start of study treatment through the completion of study treatment at 5 years. | Safety and tolerability of the ponatinib plus blinatumomab combination, based on TEAE's, graded by CTCAE V5, as well as by CRS and ICANS grading. |
| Secondary | Prognostic factors for remission | At the primary endpoint at the end of cycle 2 of blinatumomab (each cycle being 28 days). | Correlation of primary efficacy endpoints (MR4, CMR) with diagnostic NGS, IKZFplus genotype, age and baseline WBC |
| Secondary | Prognostic factors for relapse-free survival | From date of documented remission at day 70 of induction, until the date of relapse or date of death from any cause, whichever came first, assessed up to 5 years. | Correlation of RFS with diagnostic NGS, IKZFplus genotype, age and baseline WBC |
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.
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/NCT07301424
GET https://conductscience.org/api/trials/v1/NCT07301424/registered