CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 97 enrolled
Drug / intervention
doxorubicin hydrochloride +13 moredrug
Likely dose
Rituximab IV (induction and consolidation phases); Rasburicase IV (reduction phase); cytarabine, doxorubicin, cyclophosphamide, methotrexate, etoposide, vincristine, prednisone, methylprednisolone, leucovorin calcium as per LMB/FAB protocolAI-extracted
Key inclusion· 3
  • ✓Newly diagnosed mature B-lineage (CD20-positive) leukemia or lymphoma: diffuse large cell lymphoma, Burkitt's lymphoma, or high-grade B-cell lymphoma (Burkitt-like)
  • ✓FAB Group B (intermediate risk) or Group C (high risk) with bone marrow involvement (≥25% blasts) and/or CNS involvement meeting specific criteria (L3 blasts in CSF, cranial nerve palsy, spinal cord compression, intracerebral mass, or parameningeal extension)
  • ✓Hepatitis B status documented
Key exclusion· 8
  • ✕B-cell anaplastic large cell Ki-1 positive lymphomas or B-lymphoblastic lymphomas
  • ✕Prior malignancies treated with systemic chemotherapy containing alkylators or anthracyclines
  • ✕Any prior chemotherapy
  • ✕Known G6PD deficiency (relevant if receiving rasburicase)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00057811
NCT00057811Phase 2Completed
CompareCT.gov

A Pilot Study To Determine The Toxicity Of The Addition Of Rituximab To The Induction And Consolidation Phases And The Addition Of Rasburicase To The Reduction Phase In Children With Newly Diagnosed Advanced B-Cell Leukemia/Lymphoma Treated With LMB/FAB Therapy

Children's Oncology Group·interventional·Posted Apr 9, 2003·Updated Sep 19, 2014

In Brief

A Phase 2 clinical trial evaluating doxorubicin hydrochloride, cyclophosphamide, and 12 other interventions for Childhood Burkitt Lymphoma and 11 related conditions. Completed, enrolled 97 participants across 1 site.

Detailed Summary

Phase II trial to study the effectiveness of combining rituximab and rasburicase with combination chemotherapy in treating young patients who have newly diagnosed advanced B-cell leukemia or lymphoma. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug with rituximab may kill more cancer cells. Chemoprotective drugs such as rasburicase may protect kidney cells from the side effects of chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChildhood Burkitt Lymphoma, Childhood Diffuse Large Cell Lymphoma, Childhood Immunoblastic Large Cell Lymphoma, Stage I Childhood Large Cell Lymphoma, Stage I Childhood Small Noncleaved Cell Lymphoma, Stage II Childhood Large Cell Lymphoma, Stage II Childhood Small Noncleaved Cell Lymphoma, Stage III Childhood Large Cell Lymphoma, Stage III Childhood Small Noncleaved Cell Lymphoma, Stage IV Childhood Large Cell Lymphoma, Stage IV Childhood Small Noncleaved Cell Lymphoma, Untreated Childhood Acute Lymphoblastic Leukemia
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 9, 2003
Enrollment StartJun 1, 2004
Primary CompletionOct 1, 2009
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 23.2 years ago

Interventions

doxorubicin hydrochloridedrug

Given IV, IT, or orally

cyclophosphamidedrug

Given IV

methotrexatedrug

Given IV or IT

rasburicasedrug

Given IV

leucovorin calciumdrug

Given IV or orally

prednisonedrug

Given IV or orally

methylprednisolonedrug

Given IV or orally

filgrastimbiological

Given subcutaneously

rituximabbiological

Given IV

cytarabinedrug

Given IT

etoposidedrug

Given IV

vincristine sulfatedrug

Given IV

hydrocortisone sodium succinatedrug

Given IT

laboratory biomarker analysisother

Correlative studies