Trial · NCT04898894
Study of Selinexor and Venetoclax in Combination With Chemotherapy in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia
NCT04898894, Phase 1, Active not recruiting, St. Jude Children's Research Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Selinexor and Venetoclax in Combination With Chemotherapy in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia. Trials, record NCT04898894. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04898894
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Selinexor and Venetoclax in Combination With Chemotherapy in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia
- NCT number
- NCT04898894
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 37 participants, actual
- Lead sponsor
- St. Jude Children's Research Hospital
- Conditions
- Acute Leukemia of Ambiguous Lineage in Relapse, Acute Myeloid Leukemia, in Relapse, Refractory Acute Leukemia of Ambiguous Lineage, Refractory Acute Myeloid Leukemia
- Interventions
- Venetoclax, Selinexor, Cytarabine, Fludarabine, Filgrastim, Methotrexate, methotrexate/hydrocortisone/cytarabine
- First posted
- 2021-05-24
- Last updated
- 2026-10-06
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The recommended phase 2 dose (RP2D) of venetoclax plus selinexor plus chemotherapy. | For each patient, the monitoring time period for dose-limiting toxicity will extend for 35 days from receipt of the first dose of protocol-directed selinexor or venetoclax. | The primary endpoint is the recommended phase 2 dose (RP2D) of venetoclax plus selinexor plus chemotherapy. |
| Primary | Number of patients treated | 35 days from the receipt of the first dose of protocol-directed selinexor or venetoclax | A count of the number of patients treated at each dose level during the dose escalation phase will be provided |
| Primary | Number of patients who experience a Non-Hematologic dose limiting toxicity (DLT) during the dose escalation phase | Within 35 days of the first dose of chemotherapy | A count of the number of patients at each dose level who experience a Non-Hematologic DLT defined as any grade 3 or higher event that occurs within 35 days of the first dose and is at least possibly attributable to study drug administration (venetoclax, selinexor, fludarabine and/or cytarabine). |
| Primary | Number of patients who experience a Hematologic DLT during the dose escalation phase | From the start of chemotherapy up to day 43 | A count of the number of patients at each dose level who experience a Hematologic DLT defined as failure to recover counts (ANC \> 500/µl and platelet count \> 25,000/µl) by day 43 from the start of chemotherapy unless the delay in count recovery is due to another identifiable factor. |
| Secondary | The rates of complete remission (CR) for patients treated with selinexor and venetoclax in combination with chemotherapy at the RP2D. | The final response of each patient will be determined no later than day 42 from the start of chemotherapy. | CR is defined as bone marrow with \< 5% blasts confirmed by flow cytometry, ANC ≥ 500/μL and platelets ≥ 50,000/μL without transfusions, and no evidence of extramedullary disease. |
| Secondary | The rates of complete remission with incomplete count recovery (CRi) for patients treated with selinexor and venetoclax in combination with chemotherapy at the RP2D. | The final response of each patient will be determined no later than day 42 from the start of chemotherapy. | CRi is defined as bone marrow with \< 5% blasts confirmed by flow cytometry, ANC \< 500/μL or platelets \< 50,000/μL without transfusions, and no evidence of extramedullary disease |
| Secondary | The overall survival of patients treated at the RP2D. | Survival of each patient will be determined one year from enrollment. | Overall survival is defined as the time elapsed from protocol enrollment to death, with data for living patients censored at last follow-up. We will report KM estimates with 95% CIs. |
| Secondary | The rates of exceptional response for those patients treated during the Dose-escalation phase. | Day 15 | Exceptional Response is defined as patients who have at least 2-log (100-fold) reduction in bone marrow MRD at day 15 compared to bone marrow blast percentage at enrollment. |
| Secondary | The rates of exceptional response for those patients treated during the Dose Expansion Phase (Cohort A). | Day 15 | Exceptional Response is defined as patients who have at least 2-log (100-fold) reduction in bone marrow MRD at day 15 compared to bone marrow blast percentage at enrollment. |
| Secondary | The rates of exceptional response for those patients treated during the Dose Expansion Phase (Cohort B). | Day 15 | Exceptional Response is defined as patients who have at least 2-log (100-fold) reduction in bone marrow MRD at day 15 compared to bone marrow blast percentage at enrollment. |
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/NCT04898894
GET https://conductscience.org/api/trials/v1/NCT04898894/registered