Trial · NCT03817320
PO Ixazomib in Combination With Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
NCT03817320, Phase 1, Phase 2, Active not recruiting, Therapeutic Advances in Childhood Leukemia Consortium; results first posted 2025-06-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PO Ixazomib in Combination With Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma. Trials, record NCT03817320. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03817320
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PO Ixazomib in Combination With Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
- NCT number
- NCT03817320
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- Therapeutic Advances in Childhood Leukemia Consortium
- Conditions
- ALL, Childhood, Lymphoblastic Lymphoma, Childhood, Lymphoblastic Leukemia, Acute, Childhood
- Interventions
- Ixazomib, Vincristine, Dexamethasone, Asparaginase, Doxorubicin, Methotrexate (IT), Triple IT (Methotrexate, Hydrocortisone, Cytarabine), Leucovorin
- First posted
- 2019-01-25
- Last updated
- 2025-06-17
- Results first posted
- 2025-06-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Dose Limiting Toxicity (DLT) During Block 1 of Chemotherapy | 5 weeks | The incidence of dose limiting toxicity (DLT) will be measured only during block 1 |
| Primary | Phase 2: Response (CR + CR MRD-, and CR + CR MRD- + CRi) After Block 1 Chemotherapy at the RP2D | End of Block 1 treatment, Day 29-35 of treatment, assessed within 35 days from treatment start | The count of participants below represents the number of patients who achieved CR MRD- or CRi MRD- at the end of block 1 treatment and treated at RP2D (recommended phase 2 dose). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1: Dose Limiting Toxicity (DLT) During Block 1 of Chemotherapy | 5 weeks | Patients with Down Syndrome enrolled in Ixazomib Dose Level 1 (Stratum B) are not eligible for inclusion in the primary DLT or response evaluation. Only the first 6 patients enrolled in Dose Level 2 Stratum A were part of the Phase I portion of this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2: Response (CR + CR MRD-, and CR + CR MRD- + CRi) After Block 1 Chemotherapy at the RP2D | End of Block 1 treatment, Day 29-35 of treatment, assessed within 35 days from treatment start | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1: Dose Limiting Toxicity (DLT) During Block 1 of Chemotherapy | Ixazomib Dose Level 1 (Stratum A) | 0 | Participants | ||
| Phase 1: Dose Limiting Toxicity (DLT) During Block 1 of Chemotherapy | Ixazomib Dose Level 2 (Stratum A) | 0 | Participants | ||
| Phase 2: Response (CR + CR MRD-, and CR + CR MRD- + CRi) After Block 1 Chemotherapy at the RP2D | Ixazomib Dose Level 2 (Stratum A) | 10 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ixazomib Dose Level 1 (Stratum A) | 3 | |
| Overall Study | STARTED | Ixazomib Dose Level 2 (Stratum A) | 20 | |
| Overall Study | STARTED | Ixazomib Dose Level -1 (Stratum A) | 0 | |
| Overall Study | STARTED | Ixazomib Dose Level 1 (Stratum B) | 1 | |
| Overall Study | COMPLETED | Ixazomib Dose Level 1 (Stratum A) | 3 | |
| Overall Study | COMPLETED | Ixazomib Dose Level 2 (Stratum A) | 18 | |
| Overall Study | COMPLETED | Ixazomib Dose Level -1 (Stratum A) | 0 | |
| Overall Study | COMPLETED | Ixazomib Dose Level 1 (Stratum B) | 1 | |
| Overall Study | NOT COMPLETED | Ixazomib Dose Level 1 (Stratum A) | 0 | |
| Overall Study | NOT COMPLETED | Ixazomib Dose Level 2 (Stratum A) | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events594
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | Ixazomib Dose Level 1 (Stratum A) | 1 | 3 | |
| other | Abdominal distension | Gastrointestinal disorders | Ixazomib Dose Level 2 (Stratum A) | 2 | 20 | |
| other | Abdominal distension | Gastrointestinal disorders | Ixazomib Dose Level 1 (Stratum B) | 0 | 1 | |
| other | Abdominal Pain | Gastrointestinal disorders | Ixazomib Dose Level 1 (Stratum A) | 0 | 3 | |
| other | Abdominal Pain | Gastrointestinal disorders | Ixazomib Dose Level 2 (Stratum A) | 6 | 20 | |
| other | Abdominal Pain | Gastrointestinal disorders | Ixazomib Dose Level 1 (Stratum B) | 0 | 1 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Ixazomib Dose Level 1 (Stratum A) | 1 | 3 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Ixazomib Dose Level 2 (Stratum A) | 6 | 20 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Ixazomib Dose Level 1 (Stratum B) | 0 | 1 | |
| other | Acute kidney injury | Renal and urinary disorders | Ixazomib Dose Level 1 (Stratum A) | 0 | 3 |
1 to 10 of 594Source ClinicalTrials.gov
See all 594 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ixazomib Dose Level 1 (Stratum A) | 1 | 3 |
| Total, all-cause mortality | Ixazomib Dose Level 2 (Stratum A) | 3 | 20 |
| Total, all-cause mortality | Ixazomib Dose Level 1 (Stratum B) | 0 | 1 |
| Total, other adverse events | Ixazomib Dose Level 1 (Stratum A) | 3 | 3 |
| Total, other adverse events | Ixazomib Dose Level 2 (Stratum A) | 20 | 20 |
| Total, other adverse events | Ixazomib Dose Level 1 (Stratum B) | 1 | 1 |
| Total, serious adverse events | Ixazomib Dose Level 1 (Stratum A) | 2 | 3 |
| Total, serious adverse events | Ixazomib Dose Level 2 (Stratum A) | 14 | 20 |
| Total, serious adverse events | Ixazomib Dose Level 1 (Stratum B) | 1 | 1 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42376206 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ixazomib Dose Level 1 (Stratum A) vs Ixazomib Dose Level 2 (Stratum A): Phase 1: Dose Limiting Toxicity (DLT) During Block 1 of Chemotherapy |
Source Trial comparisons
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/NCT03817320
GET https://conductscience.org/api/trials/v1/NCT03817320/events?page=2