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Clofarabine incorporated into a 5-drug regimen

Phase 1

Lymphoblastic Leukemia, Acute, Childhood | Small molecule | Oncology |Sanofi|Last Updated: Apr 30, 2015

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

Clofarabine incorporated into a 5-drug regimen · 1 trial · 1 indication

Phase 1 1
NCT00991133A Safety and Tolerability Study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase, and Vincristine in Pediatric Acute Lymphoblastic Leukemia (ALL)Lymphoblastic Leukemia, Acute, Childhood
COMPLETED8 Analytics
PHASE1COMPLETED
A Safety and Tolerability Study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase, and Vincristine in Pediatric Acute Lymphoblastic Leukemia (ALL)
Lymphoblastic Leukemia, Acute, ChildhoodUnlock trial analytics

Study Endpoints

Primary Endpoints

The incidence of DLTs (Dose Limiting Toxicities) experienced with 1 cycle of this 5-drug regimen in this patient population (in all patients who receive any doses of study drugs)
1 cycle

Secondary Endpoints

Overall toxicity profile documented by incidence of AEs, SAEs, and/or DLTs
1 cycle
Efficacy as documented by complete remission (CR), time and duration of remission, event-free survival (EFS), 4-month EFS, disease-free survival (DFS), and overall survival
2 cycles
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ClofarabineEXPERIMENTALPatients received a maximum of 2 cycles of the intravenous (IV) 5-drug regimen (clofarabine, etoposide,cyclophosphamide, PEG-asparaginase, and vincristine) plus intrathecal methotrexate, and then entered follow-up. Patients who achieved complete remission (CR) or complete remission with incomplete platelet recovery (CRp) after 1 cycle of study drugs were eligible to receive a second cycle of study drugs upon recovery of peripheral blood counts, and patients who did not have leukemic progression were eligible to receive a second treatment cycle at the investigator's discretion.

Interventions

NameTypeDescription
Clofarabine incorporated into a 5-drug regimenDRUGClofarabine (IV) 40mg/m2 into an intensive chemotherapy regimen of etoposide, cyclophosphamide, PEG-asparaginas, and vincristine
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Eligibility Criteria

Age Range1 Year to 30 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Be in first relapse with \>25% blasts in the bone marrow with a duration of first remission of ≥6 months and no longer in the intensive phase(s) of initial ALL therapy (e.g., patients who are in the maintenance or continuation phases of therapy \[or beyond\] and who have compl...

Countries:United States
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