CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 128 enrolled
Drug / intervention
COPAD +2 moredrug
Likely dose
COP, COPD M3, CYM 3000 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01046825
NCT01046825Phase 3Active

Mature B-Cell Lymphoma And Leukemia Study III

St. Jude Children's Research Hospital·interventional·Posted Jan 12, 2010·Updated Jun 2, 2026

In Brief

A Phase 3 clinical trial evaluating COPAD, COP, COPD M3, CYM, and 1 other intervention for Mature B-Cell Lymphoma. Active but no longer recruiting, targeting 128 participants across 4 sites in 3 countries.

Detailed Summary

This is a phase III clinical trial using risk-adapted therapy. Treatment outcomes for children with B-cell NHL are excellent. Further improvements in outcome will likely be achieved through more focused study of the biology of the tumors and prospective studies of the late effects of treatment. Toward this end, this study features a spectrum of prospective biologic and late effect studies performed in patients treated with a modified regimen derived from the very successful LMB-96 regimen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt, Singapore, United States
Collaborators--

Timeline

Phase 3Active
2010201120122013201420152016201720182019202020212022202320242025202620272028
First PostedJan 12, 2010
Enrollment StartSep 9, 2010
Primary CompletionAug 31, 2023
Study CompletionAug 1, 2027
TodayJul 2, 2026
Enrollment to primary: 13.0 yearsPosted 16.5 years ago

Interventions

COPADdrug

Vincristine Prednis(ol)one, Cyclophosphamide, Doxorubicin, G-CSF In the event the patient cannot receive G-CSF, Pegfilgrastim can be substituted.

COP, COPD M3, CYMdrug

GROUP B Treatment Details Intravenous fluids should be given at a rate of 3000 mL/m2/day. Use of rasburicase may preclude the need for HCO3 Pre-Phase: Cyclophosphamide, Vincristine, Prednis(ol)one, IT medications Induction (2 cycles): Vincristine, Prednis(ol)one, Methotrexate, Leucovorin, Cyclophosphamide, Doxorubicin, IT medications, G-CSF, Rituximab Consolidation (2 cycles): Methotrexate, Leucovorin, Cytarabine, IT medications, G-CSF, Rituximab In the event the patient cannot receive G-CSF, Pegfilgrastim can be substituted.

COP, COPADM8, CYVEdrug

Treatment: Intravenous fluids should be given at a rate of 3000 mL/m2/day. Use of rasburicase may preclude the need for HCO3. COP Pre-Phase: Cyclophosphamide, Vincristine, Prednis(ol)one, IT medications, Leucovorin. COPADM8 Induction (2 cycles): Vincristine, Prednis(ol)one, Methotrexate, Leucovorin, Cyclophosphamide, Doxorubicin, Rituximab, IT medications, G-CSF CYVE Consolidation (2 cycles): Cytarabine, High-Dose Ara-C, Etoposide, Rituximab, G-CSF. Maintenance No.1: Vincristine, Prednis(ol)one, Cyclophosphamide, Methotrexate, Leucovorin, Doxorubicin, IT medications, G-CSF. Maintenance No.2: Cytarabine, Etoposide, G-CSF, IT Medications. Maintenance No.3: Vincristine, Prednis(ol)one, Cyclophosphamide, Doxorubicin, G-CSF, IT Medications. Maintenance No. 4: Cytarabine, Etoposide, G-CSF, IT Medications. In the event the patient cannot receive G-CSF, Pegfilgrastim can be substituted.