Trial · NCT05748171
A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL
NCT05748171, Phase 2, Recruiting, Pfizer
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL. Trials, record NCT05748171. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05748171
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL
- NCT number
- NCT05748171
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 100 participants, estimated
- Lead sponsor
- Pfizer
- Conditions
- ACUTE LYMPHOBLASTIC LEUKEMIA
- Interventions
- Inotuzumab ozogamicin, ALLR3
- First posted
- 2023-02-28
- Last updated
- 2026-09-24
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Minimum Residual Disease (MRD) Negativity in participants achieving complete response (CR), complete response with incomplete platelet count recovery (CRp), or complete response with incomplete count recovery (CRi) | After 1 treatment cycle: Day 28 +/- 2 days | MRD negativity status is determined based on the minimum MRD percentage between the date of CR/CRp/CRi and end of treatment test as assessed by RQ-PCR, with reflex to FC result if MRD is non-evaluable by RQ-PCR |
| Secondary | Event Free Survival (EFS) | From study start to first event (progression, relapse, failure to achieve CR/CRp/CRi by the end of induction, MRD persistence prior to HSCT [hematopoietic stem cell transplant], second malignancy, or death): up to 5 years from randomization | EFS will be summarized using Kaplan-Meier methods and displayed graphically by treatment arm. |
| Secondary | Duration of Response (DoR) for Participants Who Achieved CR/CRp/CRi | From date of first response to date of first event (objective progression, relapse as determined by investigator assessment, MRD persistence prior to HSCT, or death due to any cause, whichever occurs first): up to 5 years from End of Treatment | DoR will be summarized using Kaplan-Meier methods. |
| Secondary | Rate of hematopoietic stem cell transplantation (HSCT) | Up to 5 years from randomization | HSCT rate will be summarized by descriptive analyses (ie, percentage of participants who underwent HSCT after treatment). |
| Secondary | Overall Survival (OS) | From start of treatment to date of death due to any cause: up to 5 years from randomization | OS will be summarized by treatment arm using Kaplan-Meier methods. |
| Secondary | Number of participants reporting an Adverse Event (AE) | From time of informed consent up to a minimum of 60 calendar days after the last dose of study drug. | The number and percentage of participants who experienced any AE, SAE (Serious Adverse Event), treatment related AE, and treatment related SAE will be summarized according to worst toxicity grades. |
| Secondary | Pharmacokinetics (PK) parameter: InO Cmax | 1 treatment cycle: 28 days | Descriptive summary statistics will be provided for InO serum concentrations at scheduled visits. |
| Secondary | Number of Adverse Events (AE) reported by severity | From time of informed consent up to a minimum of 60 calendar days after the last dose of study drug. | AEs will be graded by the investigator according to the CTCAE (Common Terminology Criteria for Adverse Events) version 4.03. |
| Secondary | Pharmacokinetics (PK) parameter: InO trough levels | 1 treatment cycle: 28 days | Descriptive summary statistics will be provided for InO serum concentrations at scheduled visits. |
| Secondary | Rate of Chimeric antigen receptor (CAR) T-cell therapy | Up to 5 years from randomisation | CAR T-cell therapy rate will be summarized by descriptive analyses (ie, the number, percent of participants who underwent CAR T-cell therapy after treatment). |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41671463 | DERIVED |
Source PubMed
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/NCT05748171
GET https://conductscience.org/api/trials/v1/NCT05748171/registered