Trial · NCT07564453
Full-course Immunotherapy Combined With Chemotherapy in Newly Diagnosed B-cell Acute Lymphoblastic Leukemia
NCT07564453, Phase 2, Recruiting, The First Affiliated Hospital of Soochow University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Full-course Immunotherapy Combined With Chemotherapy in Newly Diagnosed B-cell Acute Lymphoblastic Leukemia. Trials, record NCT07564453. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07564453
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Full-course Immunotherapy Combined With Chemotherapy in Newly Diagnosed B-cell Acute Lymphoblastic Leukemia
- NCT number
- NCT07564453
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 101 participants, estimated
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Conditions
- B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
- Interventions
- Blinatumomab, Induction Chemotherapy, Hyper-CVAD, Allogeneic hematopoietic stem cell transplantation, CAR-T cell therapy
- First posted
- 2026-05-04
- Last updated
- 2026-05-04
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 2-year relapse-free survival (RFS) | From enrollment through 2 years post-last patient enrolled | Defined as the time from enrollment to relapse, death from any cause, or last follow-up, whichever occurs first. |
| Secondary | 2-year overall survival (OS) | From enrollment through 2 years post-last patient enrolled | Defined as the time from enrollment to death from any cause or last follow-up, whichever occurs first. |
| Secondary | Composite Complete Remission (CR/CRi) Rate after Induction Therapy | From randomization to 2 cycles of induction before consolidation therapy(100 days) | Proportion of patients achieving complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) after induction phase.CRc is evaluated at: 1) Day 22 after initial induction therapy; 2) After re-induction with blinatumomab for 2 weeks (for patients not achieving CRc at Day 22) |
| Secondary | Minimal Residual Disease (MRD) Negativity Rate | From randomization to 2 cycles of induction before consolidation therapy(100 days) | Proportion of patients achieving MRD negativity (detected by next-generation sequencing, NGS, sensitivity ≥10-⁵) at multiple time points: after first Hyper-CVAD-B chemotherapy, after second Hyper-CVAD-B chemotherapy, and after CD19-CART2 therapy. MRD negativity is defined as \<10-⁵ leukemic blasts in bone marrow. |
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/NCT07564453
GET https://conductscience.org/api/trials/v1/NCT07564453/registered