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NCT07175415: HEM-iSMART E
HEM-iSMART E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological Malignancies
Phase 1, PHASE2 trial testing Capivasertib in Acute Lymphoblastic Leukemia in 42 participants. Not yet recruiting.
1 October 2031
Quick facts
| Lead sponsor | Princess Maxima Center for Pediatric Oncology |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 1 October 2026 |
| Primary completion | 1 October 2031 |
| Estimated completion | 1 October 2032 |
Drugs / interventions tested
- Capivasertib — full drug profile →
- Venetoclax (venetoclax) — full drug profile →
- Dexamethasone (dexamethasone) — full drug profile →
- Intrathecal chemotherapy — full drug profile →
Conditions studied
- Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →
- Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Recurrent — all drugs for Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Recurrent →
- Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Refractory — all drugs for Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Refractory →
- Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Recurrent — all drugs for Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Recurrent →
Sponsor
Princess Maxima Center for Pediatric Oncology — full company profile →
Who can join
Adults 2 to 21, any sex, with Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Recurrent. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
HEM-iSMART is a master protocol which investigates multiple investigational medicinal products in children, adolescents and young adults (AYA) with relapsed/refractory (R/R) ALL and LBL. Sub-protocol E is a phase I/II trial evaluating the safety and efficacy of capivasertib + venetocolax in combination with dexamethasone in children and AYA with R/R ped ALL/LBL whose tumor present with alterations of the PAM pathway, or lacking any mutations.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Targeted therapies in pediatric oncology: A start.
Shah N. · · 2026 · PMID 41994561 · DOI 10.1016/j.omton.2026.201146
Verify or expand the search:
- PubMed search for NCT07175415
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT07343960 — A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Imp · Phase 1 · recruiting
- NCT06982521 — Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PI · Phase 3 · recruiting
- NCT07088913 — A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Rosuvastatin in Healthy Participants · Phase 1 · completed
Other recruiting trials for Acute Lymphoblastic Leukemia
Currently open trials in the same condition.
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- NCT07356154 — A Study of Revumenib and Mezigdomide in People With Leukemia · Phase 1, PHASE2 · recruiting
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Other Princess Maxima Center for Pediatric Oncology trials
Trials by the same sponsor.
- NCT07399821 — An Imaging Study of Anti-GD2-800CW in Patients With Neuroblastoma · Phase 1, PHASE2 · recruiting
- NCT05745714 — HEM-iSMART-C: Ruxolitinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric Patients With Rela · Phase 1, PHASE2 · recruiting
- NCT05751044 — HEM-iSMART-B: Dasatinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric Patients With Relaps · Phase 1, PHASE2 · recruiting
- NCT07020260 — The PACMAN-Hu19 Trial: a Study of the Safety and Feasibility of Locally Produced, CD19-targeted and Human CAR T-cell The · Phase 1, PHASE2 · not yet recruiting
- NCT06485947 — Study Combining Dinutuximab Beta With Two Chemotherapy Regimens in Neuroblastoma · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07175415 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Princess Maxima Center for Pediatric Oncology
- Last refreshed: 16 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07175415.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing