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Intrathecal chemotherapy

DRUG10 trials

Sponsors

H. Lee Moffitt Cancer Center and Research Institute, Hoffmann-La Roche, Janssen Research & Development, LLC, Princess Maxima Center for Pediatric Oncology, Fudan University

Conditions

Acute Leukemia of Ambiguous LineageAcute LeukemiasAcute Lymphoblastic LeukemiaAcute Lymphoblastic Leukemia (ALL)Acute Lymphoblastic Leukemia, in RelapseAcute Myeloid LeukemiaAcute Myeloid Leukemia (AML)HER2-negative Breast Cancer

Phase 1

Vincristine, Dexamethasone, Doxorubicin, and PEG-asparaginase (VPLD) and Metformin for Relapsed Childhood Acute Lymphoblastic Leukemia (ALL)
CompletedNCT01324180
H. Lee Moffitt Cancer Center and Research InstituteAcute Lymphoblastic Leukemia
Start: 2011-07-18End: 2017-07-27Updated: 2017-08-07
A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in Treatment of Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias or Solid Tumors
TerminatedNCT04029688
Hoffmann-La RocheAcute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Neuroblastoma +1
Start: 2020-01-27End: 2024-05-06Updated: 2024-12-20
A Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias
WithdrawnNCT05521087
Janssen Research & Development, LLCAcute Leukemia of Ambiguous Lineage, Acute Leukemias, Acute Lymphoblastic Leukemia +1
Start: 2025-12-26End: 2030-01-29Updated: 2025-06-22
HEM iSMART-D: Trametinib + Dexamethasone + Chemotherapy in Children With Relapsed or Refractory Hematological Malignancies
RecruitingNCT05658640
Princess Maxima Center for Pediatric OncologyAcute Lymphoblastic Leukemia, in Relapse, Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Recurrent, Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Refractory +2
Start: 2023-11-14End: 2029-04-01Target: 26Updated: 2025-09-16
HEM-iSMART-A: Decitabine / Venetoclax and Navitoclax in Pediatric Patients With Relapsed or Refractory Hematological Malignancies
WithdrawnNCT05740449
Princess Maxima Center for Pediatric OncologyAcute Lymphoblastic Leukemia, in Relapse, Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Recurrent, Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Refractory +2
Start: 2023-10-01End: 2029-10-01Updated: 2024-06-21
HEM-iSMART-C: Ruxolitinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric Patients With Relapsed or Refractory Hematological Malignancies
RecruitingNCT05745714
Princess Maxima Center for Pediatric OncologyAcute Lymphoblastic Leukemia, in Relapse, Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Recurrent, Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Refractory +2
Start: 2025-10-01End: 2032-02-02Target: 26Updated: 2025-09-16
HEM-iSMART-B: Dasatinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric Patients With Relapsed or Refractory Hematological Malignancies
RecruitingNCT05751044
Princess Maxima Center for Pediatric OncologyAcute Lymphoblastic Leukemia, Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Recurrent, Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Refractory +2
Start: 2025-10-01End: 2032-02-01Target: 26Updated: 2025-09-16
HEM-iSMART E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological Malignancies
Not yet recruitingNCT07175415
Princess Maxima Center for Pediatric OncologyAcute Lymphoblastic Leukemia, Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Recurrent, Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Refractory +2
Start: 2026-10-01End: 2032-10-01Target: 42Updated: 2025-09-16

Phase 2

Furmonertinib Combined With Intrathecal Chemotherapy and Stereotactic Radiotherapy (SRT) for EGFR-Mutated NSCLC Patients With Brain Parenchymal and Leptomeningeal Metastases
RecruitingNCT07304739
Tianjin Medical University Cancer Institute and HospitalNon Small Cell Lung Cancer
Start: 2025-12-22End: 2029-12-30Target: 30Updated: 2025-12-26

Phase 4

Intrathecal Chemotherapy Through Ommaya Reservoir Upon Her-2 Negative Breast Cancer With Leptomeningeal Metastasis
RecruitingNCT06230055
Fudan UniversityHER2-negative Breast Cancer, Leptomeningeal Metastasis
Start: 2024-01-05End: 2027-01-01Target: 37Updated: 2025-11-25

Related Papers

Idasanutlin in Combination with Chemotherapy or Venetoclax in Pediatric and Young Adult Patients with Relapsed/Refractory Solid Tumors (iMATRIX Idasa): Results of a Phase I/II, Multicenter, Multi-arm Study.
2025-12-11
Phase 1 study of the MDM2 antagonist RO6839921 in patients with acute myeloid leukemia
Investigational New Drugs2020-02-0418 citations
Abstract CT145: A phase I window, dose escalating and safety trial of Metformin in combination with induction chemotherapy (VPLD)in relapsed/refractory acute lymphoblastic leukemia: NCT01324180
Cancer Research2017-07-01
A phase I window, dose escalating and safety trial of metformin in combination with induction chemotherapy in relapsed refractory acute lymphoblastic leukemia: Metformin with induction chemotherapy of vincristine, dexamethasone, doxorubicin, and PEG-asparaginase (VPLD).
Journal of Clinical Oncology2016-05-20