University of Iowa Hospitals and Clinics

Clinical Trial Details

Short Title
Treatment of Patients with Newly Diagnosed Standard Risk Lymphoblastic Leukemia (B-ALL) or localized B-Lineage Lymphoblastic Lymphoma (B-LLy)
Official Title

Treatment of Patients with Newly Diagnosed Standard Risk Lymphoblastic Leukemia (B-ALL) or localized B-Lineage Lymphoblastic Lymphoma (B-LLy)

Description

Treatment of Patients with Newly Diagnosed Standard Risk Lymphoblastic Leukemia (B-ALL) or localized B-Lineage Lymphoblastic Lymphoma (B-LLy)

Participants in this study have newly diagnosed B-lymphoblastic leukemia (B-ALL) or B-lymphoblastic lymphoma (B-LLy). Patients with Down Syndrome are eligible.

The purpose of this study is to :

1. To determine if a Maintenance regimen containing weekly oral methotrexate at 40 mg/m²/week will result in an improved disease free survival (DFS) compared to that containing weekly oral methotrexate at 20 mg/m²/week in the AR subset of patients with Standard Risk B-precursor ALL.

2. To determine whether a reduced-pulses Maintenance regimen with vincristine/dexamethasone pulses delivered every 12 weeks can be used without adversely impacting DFS as compared to pulses given every 4 weeks in the AR subset of patients with Standard Risk B-precursor ALL.

3. To confirm that patients in the LR subset of Standard Risk B-precursor ALL, based on clinical and cytogenetic features and minimal residual disease (MRD) criteria, can attain a 5-year DFS of at least 95% with either a P9904-based regimen that includes 6 courses of intermediate dose (1 g/m2 over 24 hours) methotrexate without alkylating agents or anthracyclines (Arm LR-M), or an outpatient based regimen identical to that of AR patients with reduced vincristine/dexamethasone pulses at 12 week intervals during Maintenance (Arm LR-C).

4. To provide standardized treatment and enhanced supportive care to children with SR DS-ALL in order to improve outcomes and facilitate further study of this biologically and clinically unique patient subgroup.

5. To improve understanding of the biology of localized B-LLy and DS b-LLy by obtaining biologic data, Including FISH for recurrent cytogenetic lesions on paraffin specimen, and banking tissue for future research.

6. To describe the 5-year EFS and overall survi

Start Date
August 9, 2010
End Date
August 15, 2015
Gender Preference
None
Age Group
1 - 9 years
Principal Investigator
Ayman El-Sheikh, MD
Contact Info

Victoria Scaccia, 319 356-7875

Department
Department or Field of Study
Keywords
B-Lymphoblastic leukemia ; B-Lymphoblastic lymphoma ; cancer ; dexamethasone ; leukemia ; methotrexate ; pediatric ; Phase III ; vincristine ;

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