Trial · NCT07259707
Gilteritinib Plus VA Followed By Consolidation Chemotherapy in Newly Diagnosed FLT3-ITD+ AML
NCT07259707, Phase 2, Recruiting, First Affiliated Hospital of Zhejiang University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gilteritinib Plus VA Followed By Consolidation Chemotherapy in Newly Diagnosed FLT3-ITD+ AML. Trials, record NCT07259707. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07259707
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gilteritinib Plus VA Followed By Consolidation Chemotherapy in Newly Diagnosed FLT3-ITD+ AML
- NCT number
- NCT07259707
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 25 participants, estimated
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Conditions
- Acute Myeloid Leukemia, FLT3 Internal Tandem Duplication Positive, Intermediate Risk Acute Myeloid Leukemia, Fit Patients
- Interventions
- GVA + HDAC Consolidation & Gilteritinib Maintenance
- First posted
- 2025-12-02
- Last updated
- 2026-02-04
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite Complete Remission (CRc) Rate after 2 induction cycles | At day 28 of cycle 2 of GVA induction therapy (each cycle is typically 28 days with 2-weeks intervals). | CRc is defined as the proportion of participants achieving CR or CRi based on 2022 ELN criteria. CR: Bone marrow blasts \<5%, ANC ≥1.0 x 10⁹/L, platelets ≥100 x 10⁹/L, no extramedullary disease, and transfusion independence. CRi: Bone marrow blasts \<5%, no extramedullary disease, and insufficient hematologic recovery to qualify for CR. |
| Secondary | MRD Negativity Rate | At the time of CRc assessment (at day 28 of cycle 2). | The proportion of participants who achieve CRc and subsequently achieve Measurable Residual Disease (MRD) negativity, defined as \< 0.1% by multiparameter flow cytometry. |
| Secondary | Deep Molecular Negativity Rate (for FLT3-ITD) | At the time point for CRc assessment (at day 28 of cycle 2) | The proportion of participants who achieve deep molecular negative, defined as \< 0.0001% (10\^-6) via the DeepScan molecular assay, to the patients who achieved CRc |
| Secondary | Overall Survival (OS) | follow up 24 months | Time from enrollment to death from any cause, whichever came first (censored at last follow-up for survivors) |
| Secondary | Leukemia-Free Survival (LFS) | follow up 24 months. | Time from first composed complete remission to relapse or death, whichever occurred first |
| Secondary | Molecular Free Survival (mLFS) | follow up 24 months | The time from first deep molecular negative (FLT3-ITD \< 0.0001%) to molecular relapse (above the 0.0001% threshold) or death from any cause |
| Secondary | Cumulative Incidence of Relapse (CIR) | follow up 24 months | The cumulative probability of morphologic relapse, considering death without relapse as a competing risk. |
| Secondary | Cumulative Incidence of Molecular Relapse (mCIR) | follow up 24 months | The cumulative probability of molecular relapse, defined as the re-emergence of FLT3-ITD at or above the 0.0001% threshold, to participants who achieved deep molecular negativity, considering death without molecular relapse as a competing risk. |
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/NCT07259707
GET https://conductscience.org/api/trials/v1/NCT07259707/registered