Mature B-Cell Lymphoma And Leukemia Study III

This study is currently recruiting participants.
Verified April 2012 by St. Jude Children’s Research Hospital

First Received on January 8, 2010.  
Last Updated on April 18, 2012  
History of Changes
This Clinical Trial Sponsored By: St. Jude Children’s Research Hospital
Information provided by (Responsible Party): St. Jude Children’s Research Hospital
ClinicalTrials.gov Identifier: NCT01046825
 

Purpose for Clinical Trial

This is a phase II/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.

Condition Study Intervention Clinical Trial Phase
Mature B-Cell Lymphoma Drug: COPAD
Drug: COP, COPD M3, CYM
Drug: COP, COPADM8, CYVE
Phase 3

Study Type: Study Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Study Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mature B-Cell Lymphoma And Leukemia Study III

Resource links provided by NLM:

MedlinePlus related topics:
Cancer
Leukemia
Lymphoma

U.S. FDA Resources

Further study details as provided by St. Jude Children’s Research Hospital:

Primary Outcome Measures For Clinical Trial:

  • To perform transcriptional profiling and genome-wide analysis of DNA copy number abnormalities and loss-of-heterozygosity using DNA microarrays in children with newly diagnosed mature B cell lymphomas [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To describe the types and frequency of mutations in the ARF-HDM2-TP53 pathway, in B-cell lymphomas in the United States and those found in selected geographic regions of the world. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To describe the expression of ARF-HDM2-TP53 and PUMA-associated pathways in B-cell lymphomas in the United States and that found in B-cell lymphomas of other selected geographic regions of the world [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To describe the pattern and frequency of XLP gene mutations presenting with B-cell lymphomas in the United States and selected geographic regions. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To describe the pattern of EBV protein expression (e.g., EBNA 3) in EBV-positive lymphomas and to compare patterns of EBV protein expression with clinical, laboratory and outcome data. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To establish a tumor bank of mature B-cell lymphoma samples for future molecular studies aimed to clarify the role of c-MYC oncogene and its associated pathways,and other pathways found to harbor genetic alterations from the genomic profiling studies [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures For Clinical Trial:

  • This study will include the study of acute and late effects of this treatment on the central nervous system, bone mineral density, fertility, and cardiac system. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2010
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Group A

Completely resected stage I or completely resected abdominal stage II lesions.

Group A will include: COPAD x 2 cycles.

Drug: COPAD

Vincristine Prednis(ol)one, Cyclophosphamide, Doxorubicin, G-CSF
Group B

All cases not eligible for Group A or Group C. (Murphy Stage III and non-CNS Stage IV)

Group B will include:

Pre-Phase: COP; Induction: COPAD M3 x 2 cycles; Consolidation: CYM x 2 cycles.

Drug: COP, COPD M3, CYM

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
Group C

Any CNS involvement and/or bone marrow involvement ≥ 25% blasts. For CNS involvement one or more of the following applies:

  1. Any L3 blasts in CSF
  2. Cranial nerve palsy (if not explained by extracranial tumor)
  3. Clinical spinal cord compression
  4. Isolated intracerebral mass
  5. Parameningeal extension: cranial and/or spinal

Group C will include:

Pre-Phase: COP; Induction: COPADM8 cycle 1; Induction: COPADM8 Cycle 2; Consolidation: CYVE x 2 cycles and Maintenance

Drug: COP, COPADM8, CYVE

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, IT medications, G-CSF CYVE Consolidation (2 cycles): Cytarabine, High-Dose Ara-C, Etoposide, 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.

Detailed Description:

  1. This study will perform transcriptional profiling and genome-wide analysis of DNA copy number abnormalities and loss-of-heterozygosity using DNA microarrays in children with newly diagnosed diffuse large B-cell lymphomas (DLBCL) and small non-cleaved lymphomas from different parts of the world.
  2. This study will describe the types and frequency of mutations in the ARF-HDM2-TP53 pathway, in "non-endemic" B-cell lymphomas (United States) and those found in selected geographic regions of the world (Brazil, Chile, Guatemala, Honduras, El-Salvador, Singapore and others).
  3. This study will describe the expression of ARF-HDM2-TP53 and PUMA-associated pathways in non-endemic B-cell lymphomas (United States) and that found in B-cell lymphomas of other selected geographic regions of the world (see above).
  4. This study will describe the pattern and frequency of XLP gene mutations in boys presenting with B-cell lymphomas in the United States and selected geographic regions.
  5. This study will describe the frequency of EBV-positive B-cell lymphomas in the United States and selected geographic regions of the world: and will describe the pattern of EBV protein and gene expression (e.g., EBNA 3) in EBV-positive lymphomas and the study will compare patterns of EBV protein and gene expression with clinical, laboratory and outcome data.
  6. This study will establish a tumor bank of mature B-cell lymphoma samples for future molecular studies aimed to clarify the role of c-MYC oncogene and its associated pathways, and other pathways found to harbor genetic alterations from the genomic profiling studies described above.
  Eligibility

Ages Eligible for Study:  

Leave a Reply

You can use these HTML tags

<a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>

  

  

  

eleven + three =