Who is sponsoring NCT00476190?

NCT00476190 is sponsored by Dana-Farber Cancer Institute.

What condition does NCT00476190 study?

NCT00476190 studies Acute Lymphoblastic Leukemia.

What drugs are being tested in NCT00476190?

Interventions: Doxorubicin, Cytarabine, Methotrexate, Vincristine, Cyclophosphamide, Methylprednisone, Hydrocortisone Sodium Succinate, Dexamethasone, 6-MP, PEG-Asparaginase, Imatinib, Etoposide, Radiation Therapy, E. coli Asparaginase.

What is the status of NCT00476190?

NCT00476190 is currently COMPLETED.

Last reviewed 2025-06-10 · How we verify

ALL Adult Consortium Trial: Adult ALL Trial

NCT00476190 Phase 2 COMPLETED Results posted

The purpose of this study is to determine the safety and effectiveness of a multi-drug chemotherapy regimen in adult patients with Acute Lymphoblastic Leukemia (ALL). We will use a regimen that is often used in pediatric patients and we will add drugs called PEG-asparaginase and E. coli asparaginase. PEG-asparaginase has been given as an injection in the past and has been used in treatment with both children and adults with ALL. Information from those other research studies suggests that intravenous PEG-asparaginase has been administered safely in both children and adults. We hope to gain more information about the participants disease and how it responds to standard chemotherapy drugs used to treat ALL\>

Details

Lead sponsor	Dana-Farber Cancer Institute
Phase	Phase 2
Status	COMPLETED
Enrolment	112
Start date	2007-04
Completion	2020-03

Conditions

Acute Lymphoblastic Leukemia

Interventions

Doxorubicin
Cytarabine
Methotrexate
Vincristine
Cyclophosphamide
Methylprednisone
Hydrocortisone Sodium Succinate
Dexamethasone
6-MP
PEG-Asparaginase

Primary outcomes

Asparaginase Completion Rate — Assessed at the end of the 30-week post-induction treatment period or when the participant comes off treatment, whichever occurs first.
Feasibility based on the rate of asparaginase completed defined as the percentage of patients who, after having achieved a complete remission after induction therapy, complete \>25 weeks of IV PEG asparaginase as part of intensification therapy. Complete remission is defined as an interpretable bone marrow (a specimen with normal marrow elements present) with fewer than 5% lymphoblasts and peripheral blood without lymphoblasts, and an antigen presenting cell (APC) \> 1000/mm3 and platelets \> 100,000/mm3, and no evidence of extramedullary leukemia.
Number of Participants With Grade 3 or Worse Toxicity. — Assessed on an ongoing basis (at least once every 3 months) while on study, including the treatment phases of Induction, Consolidation I & II, CNS, and Continuation. Treatment duration for this study was a median (range) of 287 days (2-974).
Defined as the number of participants who experience the following grade 3 or worse adverse events based on Common Terminology Criteria for Adverse Events (CTCAE) v3: Neutrophils, Platelets, Febrile neutropenia, Infection, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Bilirubin, Liver dysfunction/failure, Hyperglycemia, Stomatitis, CNS hemorrhage, Thrombosis, Seizure, Osteonecrosis, Hypersensitivity, Pancreatitis, Neuropathy.

Countries

United States, Canada