Trial · NCT07573670
A Phase 2 Study of Bcl-2 Inhibitor Combined With Azacitidine for Newly Diagnosed Mixed Phenotype Acute Leukemia
NCT07573670, Phase 2, Not yet recruiting, The First Affiliated Hospital of Soochow University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 2 Study of Bcl-2 Inhibitor Combined With Azacitidine for Newly Diagnosed Mixed Phenotype Acute Leukemia. Trials, record NCT07573670. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07573670
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Study of Bcl-2 Inhibitor Combined With Azacitidine for Newly Diagnosed Mixed Phenotype Acute Leukemia
- NCT number
- NCT07573670
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 52 participants, estimated
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Conditions
- Newly Diagnosed Mixed Phenotype Acute Leukemia
- Interventions
- BCL-2 indibitor, Azacitidine (AZA), Blinatumomab
- First posted
- 2026-05-07
- Last updated
- 2026-05-07
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite Complete Response (CRc) rate after 2 cycles of induction therapy | From randomization to 2 cycles of induction before consolidation therapy（100 days） | CRc = CR + CRi; CR: bone marrow blasts \<5%, no extramedullary disease, no peripheral blasts, ANC ≥1.0×10⁹/L, PLT ≥100×10⁹/L; CRi: bone marrow blasts \<5%, no extramedullary disease, no peripheral blasts, incomplete hematologic recovery (ANC \<1.0×10⁹/L or PLT \<100×10⁹/L) |
| Secondary | MRD negativity rate | From randomization to 2 cycles of induction before consolidation therapy（100 days） | Bone marrow MRD \<0.01% detected by MFC |
| Secondary | NGS-MRD negativity rate | From randomization to 2 cycles of induction before consolidation therapy（100 days）, and test Every 3 months during follow-up | NGS-MRD can not detected by IgH/TCR NGS (NGS-based MRD will be incorporated as an exploratory complementary assay in patients with trackable clonotypic rearrangements at diagnosis) |
| Secondary | CR1 bridge-to-allo-HSCT rate | Up to 6 months after enrollment | Proportion of subjects who achieve CR/CRi and successfully receive allo-HSCT within 2-3 cycles |
| Secondary | Overall Survival (OS) | From the time from randomization to time for up to 2 years | Time from C1D1 to death from any cause; data censored at last follow-up for surviving subjects |
| Secondary | Event-Free Survival (EFS) | From the time from randomization to time for up to 2 years | Time from C1D1 to first event (no CRc after 2 cycles, morphological/extramedullary relapse, disease progression, off-protocol anti-leukemia therapy, death from any cause); data censored at last follow-up for event-free subjects |
| Secondary | Relapse-Free Survival (RFS) | From the time from randomization to time for up to 2 years | Time from first CR/CRi to relapse or death from any cause; relapse defined as bone marrow blasts ≥5%, extramedullary disease, peripheral blasts, or molecular MRD ≥10-⁴ in previously MRD-negative patients;data censored at last follow-up for relapse-free subjects |
| Secondary | 100-day Non-Relapse Mortality (100-day NRM) | Up to 100 days after initial MPAL diagnosis | Proportion of deaths from non-relapse causes within 100 days of diagnosis |
| Secondary | Incidence of grade ≥3 adverse events (AEs) | From treatment initiation to the end of Induction | Type, frequency and severity of grade ≥3 AEs graded by CTCAE v5.0 |
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/NCT07573670
GET https://conductscience.org/api/trials/v1/NCT07573670/registered