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LEUKEMIA ~ STUDY #1

Title: COG AAML0523: A Phase I/II Study of CLOLAR (Clofarabine IND# 73,789) in Combination with Dytarabine in Pediatric Patients with Refractory/Relapsed Leukemia Purpose: To find a safe dose of the drug clofarabine that can be given in combination with without causing side effects that are too severe. To find out how well a combination of the drugs clofarabine and cytarabine works against relapsed and refractory leukemias. Eligibility: Patients between 1 and 30 years of age with refractory/relapsed leukemia. Must have adequate organ function and be recovered from effects of previous therapy. Principal Investigator: Wiley, Joseph M. Phase: I/II For more information, contact: Entrup, Stephanie

Telephone Number: 410-601-8393 Email: [email protected] Approved Enrollment Number: 10

Current Enrollment: 0

LEUKEMIA ~ STUDY #2

Title: COG AAML0631: Risk Adapted Treatment of Newly Diagnosed Childhood Acute Promyelocytic Leukemia (APL) Using (Trisenox IND #103,331) During Consolidation. Purpose: Treatment of newly diagnosed Acute Promyelocytic Leukemia.(APL). To test the effects of reducing the amount of and adding arsenic to standard APL treatment. To learn more about the biology and characteristics of APL. To look for genetic changes in leukemia cells to learn more about APL and how to treat patients better. To see if there is a connection between APL and obesity. Eligibility: Anyone ages 2 - 21 years of age with newly diagnosed Acute Promyelocytic Leukemia (APL). Principal Investigator: Wiley, Joseph M. Phase: III For more information, contact: Entrup, Stephanie

Telephone Number: 410-601-8393 Email: [email protected] Approved Enrollment Number: 86

Current Enrollment: 0

LEUKEMIA ~ STUDY #3

Title: COG AALL07P1: A Phase II Pilot Trial of (PS-341, Velcade, IND #58,443) in Combination with Intensive re- Induction Therapy for Children with Relapsed Acute Leukemia (ALL) and Lymphoblastic Lymphoma (LL) Purpose: To find out if bortezomib can be safely added to the standard COG Re-Induction therapy for relapsed ALL, and be an effective therapy. Eligibility: Children and adolescents who have been treated in the past for lymphoblastic leukemia (ALL) or a cancer of tissue of the immune system and has had a relapse. Principal Investigator: Wiley, Joseph M. Phase: II For more information, contact: Entrup, Stephanie

Telephone Number: 410-601-8393 Email: [email protected] Approved Enrollment Number: 90

Current Enrollment: 0