Trial · NCT05740449
HEM-iSMART-A: Decitabine / Venetoclax and Navitoclax in Pediatric Patients With Relapsed or Refractory Hematological Malignancies
NCT05740449, Phase 1, Phase 2, Withdrawn, Princess Maxima Center for Pediatric Oncology
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. HEM-iSMART-A: Decitabine / Venetoclax and Navitoclax in Pediatric Patients With Relapsed or Refractory Hematological Malignancies. Trials, record NCT05740449. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05740449
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- HEM-iSMART-A: Decitabine / Venetoclax and Navitoclax in Pediatric Patients With Relapsed or Refractory Hematological Malignancies
- NCT number
- NCT05740449
- Status
- Withdrawn
- Phases
- Phase 1, Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- Princess Maxima Center for Pediatric Oncology
- Conditions
Acute Lymphoblastic Leukemia, in Relapse, Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Recurrent, Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Recurrent, Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Refractory, Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Refractory
- Interventions
- Decitabine, Venetoclax, Navitoclax, intrathecal chemotherapy
- First posted
- 2023-02-23
- Last updated
- 2024-06-21
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I: Maximum tolerated dose (MTD) / Recommended phase 2 dose (RP2D) | 3 years | Defined as the highest dose level tested at which 0/6 or 1/6 patients experiences dose limiting toxicities (DLT) during course 1 with at least 2 patients experiencing DLT at the next higher dose. |
| Primary | Phase II: Best overall response rate (ORR) | 6 years | For patients with leukemia: CR and MRD response after 1 cycle of treatment. This includes determination of CR, CRp, CRi and minimal residual disease (MRD) negativity rate in patients suffering from overt morphological relapse of T-ALL at time of enrolment (morphological disease (M2/M3)), and the MRD negativity rate in those that entered with high-MRD levels but in morphological CR. These results will together be presented as a composite endpoint Overall Response rate (ORR). MRD negativity will be defined as ≤1x10-4 as generated by multi-parameter flow cytometry. For patients with lymphoma: Response in LBL patients is defined as CR, PR, minor response (MR) as defined in International pediatric NHL response criteria. In case of bone-marrow involvement MRD will be taken into account. |
| Secondary | Overall survival (OS) | 7 years | Defined as time from C1D1 until death of any cause. |
| Secondary | Event-free survival (EFS) | 7 years | Defined as time from C1D1 to the first event (subsequent relapse after CR (including molecular reappearance), death of any cause, failure to achieve remission (CR, CRp or CRi), or secondary malignancy). |
| Secondary | Cumulative incidence of relapse (CIR) | 7 years | Estimate of the risk, that a patient will develop a relapse over a specified period of time. |
| Secondary | Number of patients proceeding to hematopoietic stem cell transplantation (HSCT) after the experimental therapy. | 7 years | The rate of those proceeding to subsequent allogenic HSCT |
| Secondary | Cumulative overall response rate (ORR) | 7 years | Defined as the CR, CRp, CRi and MRD negativity rates after more than 1 cycle of treatment |
| Secondary | Rate of dose limiting toxicities (DLTs) | 7 years | Number of participants with dose limiting toxicities (DLTs) |
| Secondary | Peak plasma concentration (Cmax) | 6 years | Estimation of decitabine, venetoclax and navitoclax Cmax |
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT05740449
GET https://conductscience.org/api/trials/v1/NCT05740449/registered