Study:
A Phase III Randomized Trial for Newly Diagnosed High Risk B-precursor Acute Lymphoblastic Leukemia (ALL) Testing Clofarabine (IND# 73789, NSC# 606869) in the Very High Risk Stratum
Rationale:
Drugs used in chemotherapy work in different ways to stop the growth of cancer
cells, either by killing the cells or by stopping them from dividing. Giving more than one
drug (combination chemotherapy) and giving the drugs in different doses and in different
combinations may kill more cancer cells.
Purpose:
This randomized phase III trial is studying how well combination chemotherapy works
in treating young patients with newly diagnosed high-risk acute lymphoblastic leukemia.
Study Status: Recruiting
Recruiting:
Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100
| Condition |
Intervention |
Phase |
Cognitive/Functional Effects
Leukemia
Neurotoxicity
Pain
Therapy-related Toxicity |
Drug: clofarabine
Drug: cyclophosphamide
Drug: cytarabine
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: hydrocortisone sodium succinate
Drug: leucovorin calcium
Drug: mercaptopurine
Drug: methotrexate
Drug: pegaspargase
Drug: prednisone
Drug: thioguanine
Drug: vincristine sulfate
Radiation: selective external radiation therapy |
Phase 3 |
Verified by
Children`s Oncology Group
November, 2012
Sponsored by: Children`s Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT01406756
Study Type: Interventional
Study Design: Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United States
Michael J. Burke, MD., Principal Investigator