drugset
drugset / Trial / NCT01614197

A Trial of Temsirolimus With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma

NCT01614197 ↗

Phase 1 Completed 16 enrolled Therapeutic Advances in Childhood Leukemia Consortium Pfizer · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a phase I study of temsirolimus (Torisel) combined with dexamethasone, cyclophosphamide and etoposide in patients with relapsed acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LL) or peripheral T-cell lymphoma (PTL).

Timeline

Start
2015-07-03
Primary completion
2019-12-15
Completion
2020-09-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Temsirolimus Small molecule 7.5 mg/m2 Intravenous
Subject Temsirolimus Small molecule 10 mg/m2 Intravenous
Subject Temsirolimus Small molecule 15 mg/m2 Intravenous
Subject Temsirolimus Small molecule 25 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 440 mg/m2 Intravenous
Background Cytarabine Small molecule 16 mg Intrathecal
Background Cytarabine Small molecule 20 mg Intrathecal
Background Cytarabine Small molecule 24 mg Intrathecal
Background Cytarabine Small molecule 30 mg Intrathecal
Background Cytarabine Small molecule 50 mg Intrathecal
Background Cytarabine Small molecule 70 mg Intrathecal
Background Etoposide Small molecule 100 mg/m2 Intravenous
Background Hydrocortisone Other / unclassified 8 mg Intrathecal
Background Hydrocortisone Other / unclassified 10 mg Intrathecal
Background Hydrocortisone Other / unclassified 12 mg Intrathecal
Background Hydrocortisone Other / unclassified 15 mg Intrathecal
Background Methotrexate Small molecule 8 mg Intrathecal
Background Methotrexate Small molecule 10 mg Intrathecal
Background Methotrexate Small molecule 12 mg Intrathecal
Background Methotrexate Small molecule 15 mg Intrathecal

Indications

childhood acute lymphoblastic leukemia lymphoblastic lymphoma peripheral T-cell lymphoma, not otherwise specified