Trial · NCT07227584
ALL Backbone in AYAs
NCT07227584, Phase 2, Recruiting, Dana-Farber Cancer Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ALL Backbone in AYAs. Trials, record NCT07227584. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07227584
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ALL Backbone in AYAs
- NCT number
- NCT07227584
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 67 participants, estimated
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Acute Lymphoblastic Leukemia, Philadelphia Chromosome-Negative Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia (ALL), Leukemia
- Interventions
- Blinatumomab, Oncaspar, Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin Hydrochloride, Etoposide, Mercaptopurine, Methotrexate, Vincristine
- First posted
- 2025-11-12
- Last updated
- 2026-08-17
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Completion Rate Through Time Point 3 (TP3) | Timeframe for TP3 depends on disease immunophenotype. Participants with CD19-positive B-ALL, TP3 occurs at the end of Blinatumomab Cycle 2 on Day 28 (130 days from study start). For participants with T-cell ALL or those who do not receive blinatum | Treatment completion rate through TP3 is defined as the proportion of Adolescents and Young Adults (AYAs) participants who receive all protocol-specified therapy through TP3, without early discontinuation. |
| Secondary | Rate of Treatment-Related Mortality (TRM) | Up to 115 weeks | Rate of TRM is defined as the proportion of participants who die due to treatment-related causes. |
| Secondary | Rate of Treatment Discontinuation due to Toxicity or Disease | Up to 115 weeks | Rate of treatment discontinuation during Induction, Consolidation, and Continuation phases, defined as the proportion of participants who stop protocol-specified therapy due to regimen-related toxicity and/or treatment failure. |
| Secondary | Rate of Asparaginase Non-Completion | This endpoint is assessed during Consolidation II, which occurs approximately from Day 270 to Day 480 of study treatment. | Rate of asparaginase non-completion is defined as the proportion of participants who did not complete all planned doses of asparaginase per protocol. |
| Secondary | Reason of Asparaginase Non-Completion | Up to 115 weeks | This outcome summarizes the reasons participants discontinue asparaginase treatment earlier than planned. |
| Secondary | Grade 3 Infections Toxicity Rate | Adverse events will be followed for 30 days after completion of protocol treatment, with the overall treatment period up to 115 weeks. | Grade 3 infection toxicity rate is defined as the proportion of participants who experience grade 3 bacterial or fungal infections that are assessed as possibly, probably, or definitely related to the study treatment during the induction, consolidation, and continuation phases. Toxicity grades are determined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0. |
| Secondary | Grade 3 Asparaginase-associated Toxicities Rate | Adverse events will be followed for 30 days after completion of protocol treatment, with the overall treatment period up to 115 weeks. | Grade 3 asparaginase-associated toxicity rate is defined as the proportion of participants who experience grade 3 asparaginase-associated toxicities (including thromboembolic events, pancreatitis, hypertriglyceridemia, hyperbilirubinemia, hypersensitivity, and hyperglycemia) that are assessed as possibly, probably, or definitely related to the study treatment during the induction, consolidation, or continuation phases. Toxicity grades are determined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0. |
| Secondary | Grade 3 Orthopedic Toxicity Rate | Adverse events will be followed for 30 days after completion of protocol treatment, with the overall treatment period up to 115 weeks. Ostenonecrosis and fractures will be followed up to 10 years. | Grade 3 orthopedic toxicity rate is defined as the proportion of participants who experience grade 3 osteopenia or osteoporosis that are assessed as possibly, probably, or definitely related to the study treatment at the end of treatment, or osteonecrosis (ON) or fractures during or after treatment. Toxicity grades are assigned according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0. |
| Secondary | Complete remission Rate (CRR) | CR can be documented either at the end of Induction IA (32 days) or Induction IB (74 days). | CRR is defined as proportion of participants who achieve CR. Complete response (CR) is defined as an interpretable bone marrow with less than 5% malignant lymphoblasts, no lymphoblasts in peripheral blood, an absolute phagocyte count greater than 1000/µL and platelets above 100,000/µL (for participants with M2 marrow at Day 32 who achieve CR at TP2, APC above 500/µL and platelets above 50,000/µL are acceptable), no evidence of extramedullary leukemia or blasts in spinal fluid, at least a 70% reduction in the anterior mediastinal mass if present at diagnosis as measured by the sum of the products of the two greatest diameters on CT or chest X-ray, and for any other large radiographic masses at diagnosis, a 70% reduction in SPD if restaging imaging is obtained. |
| Secondary | Measurable Residual Disease (MRD) Negativity Rate at the end of Induction IA (Time Point 1) | At the end of Induction IA (32 days from study start) | The proportion of who achieve measurable residual disease (MRD) negativity at the end of Induction IA (Time Point 1). MRD negativity is assessed by multiparameter flow cytometry (MPFC), next-generation sequencing (NGS), and/or KMT2A::AFF4 RT-PCR. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 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/NCT07227584
GET https://conductscience.org/api/trials/v1/NCT07227584/registered