Trial · NCT07301424
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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 |
| Secondary | Prognostic factors for overall survival | From date of enrollment until the date of death from any cause or last follow-up, assessed up to 5 years. | Correlation of OS with diagnostic NGS, IKZFplus genotype, age and baseline WBC |
| Other | Exploratory: comparison of different MRD outcomes | After the completion of cycle 2 of blinatumomab (each cycle being 28 days). | Concordance between MRD results in bone marrow by BCR-ABL PCR vs IgR vs flow cytometry |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT07301424/registered