Trial · NCT03959085
Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy
NCT03959085, Phase 3, Recruiting, Children's Oncology Group
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy. Trials, record NCT03959085. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03959085
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy
- NCT number
- NCT03959085
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 5,951 participants, estimated
- Lead sponsor
- Children's Oncology Group
- Conditions
- B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma, Central Nervous System Leukemia, Mixed Phenotype Acute Leukemia, Testicular Leukemia
- Interventions
Biospecimen Collection, Blinatumomab, Bone Marrow Aspiration, Bone Marrow Biopsy, Bone Scan, Calaspargase Pegol, Computed Tomography, Cyclophosphamide, Cytarabine, Daunorubicin Hydrochloride, Dexamethasone, Doxorubicin Hydrochloride, Inotuzumab Ozogamicin, Leucovorin Calcium, Magnetic Resonance Imaging, Mercaptopurine, Methotrexate, Pegaspargase, Positron Emission Tomography, Prednisolone, Prednisone, Questionnaire Administration, Radiation Therapy, Radiation Therapy, Thioguanine, Vincristine Sulfate
- First posted
- 2019-05-22
- Last updated
- 2026-08-25
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Post-induction 5-year event-free survival (EFS) | From study entry to first event (induction failure, induction death, end of induction [EOI] minimal residual disease [MRD] ≥ 5%,EO consolidation [C] MRD ≥ 0.01%, relapse, second malignancy, remission death) or date of last contact, assessed up to 5 years | Will compare in a randomized manner the post-induction 5-year EFS for children and young adults with High Risk (HR) B-cell acute lymphoblastic leukemia (B-ALL) treated with a modified Berlin-Frankfurt-Münster (mBFM) chemo-immunotherapy backbone that includes blinatumomab and replaces Consolidation Part 2 and Delayed Intensification (DI) Part 2 with two blocks of inotuzumab ozogamicin, versus those treated with a full mBFM chemo-immunotherapy backbone that includes blinatumomab and retains Consolidation Part 2 and DI Part 2 without the addition of inotuzumab ozogamicin. |
| Secondary | 5-year DFS for favorable risk subset of NCI HR B-ALL (HR favorable) when treated with mBFM chemotherapy with a single high-dose methotrexate (HD MTX) Interim Maintenance (IM) phase and treatment duration of 2 years from the start of IM regardless of sex | From EOC to first event (relapse, second malignant neoplasm, remission death) or date of last contact, assessed up to 5 years | Will be estimated using the Kaplan-Meier method and standard errors and confidence intervals estimated by the method of Peto. Estimation of treatment effect will be done using ITT analysis based on randomized group. |
| Secondary | Incidence of adverse events for the integration of inotuzumab ozogamicin into the mBFM chemotherapy backbone in HR B-ALL | Up to 5 years | Graded per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Will be monitored and reported. |
| Secondary | 5-year event-free survival (EFS) for patients with mixed phenotype acute leukemia (MPAL) receiving mBFM HR B-ALL therapy that includes a second IM phase with Capizzi escalating intravenous MTX without leucovorin rescue+pegaspargase or calaspargase pegol | From study entry to first event (induction failure, Induction death, end of induction (EOI) minimal residual disease (MRD) >= 5%, EOC MRD >= 0.01%, relapse, second malignancy, remission death) or date of last contact, assessed up to 5 years | Will be estimated using the Kaplan-Meier method and standard errors and confidence intervals estimated by the method of Peto. Estimation of treatment effect will be done using ITT analysis based on randomized group. |
| Secondary | 5-year EFS for patients with disseminated (Murphy stage III-IV) B-cell lymphoblastic lymphoma (B-LLy) receiving mBFM HR B-ALL therapy that includes a second IM phase with C-MTX | From study entry to first event (progressive disease, induction death, relapse, second malignancy, remission death) or date of last contact, assessed up to 5 years | Will be estimated using the Kaplan-Meier method and standard errors and confidence intervals estimated by the method of Peto. Estimation of treatment effect will be done using ITT analysis based on randomized group. |
| Secondary | Health-related quality of life (HRQoL) for HR B-ALL | Consolidation Part 2 Day 43 (Arm D)/Inotuzumab ozogamicin Block 1 Day 15 (Arm E) up to Day 1 of IM2 (Arms D and E) | Will compare by study arm. |
| Secondary | Incidence of symptomatic AEs for patients with HR B-ALL | Up to 5 years | Will compare by study arm using Patient Reported Outcome (PRO) Measures. |
| Other | Overall survival (OS) | Time from study entry to death or date of last contact for those alive at last contact, assessed up to 5 years | OS rates will be estimated using the Kaplan-Meier method and standard errors and confidence intervals estimated by the method of Peto. |
| Other | Therapy administered to patients with MPAL who come off protocol therapy due to poor disease response to ALL therapy | Up to 5 years | Will be described. |
| Other | Disease response in patients with MPAL who come off protocol therapy due to poor disease response to ALL therapy | Up to 5 years | Will be described. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41671463 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
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/NCT03959085
GET https://conductscience.org/api/trials/v1/NCT03959085/registered