HEM-iSMART E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological Malignancies

Sponsor
Princess Maxima Center for Pediatric Oncology
Study ID
NCT07175415
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Acute Lymphoblastic Leukemia
  • Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Recurrent
  • Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Refractory
  • Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Recurrent
  • Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Refractory

Eligibility Criteria

Sex
ALL
Age
2 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Capivasertib — DRUG
    Oral
  • Venetoclax — DRUG
    Oral
  • Dexamethasone — DEVICE
    oral/intravenous
  • Intrathecal chemotherapy — DRUG
    IT: Methotrexate +/- prednisone/hydrocortisone/cytarabine according to the degree of central nervous involvement

Study Details

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.

Key Dates

Start date
Oct 1, 2026
Status verified
Sep 2025
Primary completion
Oct 1, 2031
Completion
Oct 1, 2032

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Capivasertib + Venetoclax + Dexamethasone
    Sub-study E: Each cycle lasts 28 days. Cycle 1: All patients in cycle 1 will receive 4 blocks of of capivasertib (days D4-7, 11-14, 18-21, 25-28), 28 days of venetoclax (days 1-28), and one block of seven days of dexamethasone (days 1-7). A 1-day venetoclax ramp-up is proposed in this study. Cycle 2 and subsequent cycles: similar to cycle 1. Patients in dose level -1, receive a lower dose of venetoclax. Patients in dose level 2 receive a higher dose of capivasertib. All patients receive age adapted intrathecal chemotherapy.

Primary Outcome Measure

Phase I: Maximum tolerated dose (MTD) / Recommended phase 2 dose (RP2D). [ Time Frame: 2 years ]

Central Contacts

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