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Treatment of Burkitt Lymphoma/Leukemia and B Large Cell NHL

Primary Purpose

Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Mature B-Cell

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Prednison, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide, Doxorubicin
Sponsored by
St. Jude Children's Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin Lymphoma focused on measuring Mature B-Cell Leukemia, Non-Hodgkin Lymphoma, Burkitt's lymphoma, Small noncleaved cell non Hodgkin lymphoma, Large cell lymphoma

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject must be previously untreated, except for steroids. Subject must be less than or equal to 18 years of age. Subject must have a histologic diagnosis of small noncleaved cell (SNCC) NHL or large cell NHL (B-cell), or B-cell acute lymphocytic leukemia. Exclusion Criteria: Previously treated disease

Sites / Locations

  • St. Jude Children's Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

A

B

C

Arm Description

Group A: Resected Stage I and resected abdominal Stage II Subjects will receive two courses (3 weeks apart) of COPAD.

Group B: Other Stage II, Stage III, Stage IV or B-ALL M blast <70%; no CNS involvement. Subjects in Group B will receive one week of treatment of COP.

Group C: B-ALL with >70% BM blasts; CNS involvement, Group B COP failures i.e., <20% reduction Treatment Pre-Induction Subjects will receive one week of treatment of COP.

Outcomes

Primary Outcome Measures

The purpose of this study is estimate the complete response, event-free survival, and overall survival in patients with small non-cleaved cell non-Hodgkin lymphoma or large cell NHL, or Burkitt leukemia/B-cell ALL treated with a modified LMP-89 regimen.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
June 3, 2008
Sponsor
St. Jude Children's Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00187161
Brief Title
Treatment of Burkitt Lymphoma/Leukemia and B Large Cell NHL
Official Title
Small Noncleaved Cell (SNCC), Non-Hodgkin Lymphoma (NHL), Large Cell NHL (B-Cell) and B-Cell Acute Lymphoblastic Leukemia (B-ALL) Study II
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
November 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
St. Jude Children's Research Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a pilot study to demonstrate that the modified LMB-89 treatment regimen for children with newly diagnosed small noncleaved cell NHL, large cell NHL (B-cell), and B-cell acute lymphoblastic leukemia can be delivered in this setting with acceptable toxicity.
Detailed Description
Group A: Resected Stage I and resected abdominal Stage II Subjects will receive two courses (3 weeks apart) of COPAD as follows: Cyclophosphamide (CTX) 500 mg/m2/day (divided q12 hrs) IV day 1, 2, 3 Vincristine (VCR) 2 mg/m2 (max 2.0 mg) IV day 1, 6 Prednisone 60 mg/m2/d (divided bid) PO day 1-5 Adriamycin 60 mg/m2 over 6 hrs IV day 1 GCSF 5 mcg/kg/day SQ will be given once a day starting on day 7 until blood counts recover. Group B: Other Stage II, Stage III, Stage IV or B-ALL M blast <70%; no CNS involvement. Treatment Pre-Induction Subjects in Group B will receive one week of treatment of COP as follows: CTX 300 mg/m2 IV day 1; VCR 1 mg/m2 (max 2.0 mg) IV day 1; Prednisone 60 mg/m2/day (divided bid) PO day 1-7; Methotrexate (MTX) and hydrocortisone (HC) into the spinal fluid (IT), each age adjusted, day 1; Induction -COPADM x 2 (COPAD M3 #1 (starting day 8 COP if greater than or equal to 20% reduction in tumor size by day 7 COP; if <20% then proceed to Group C starting at COPADM8 No. 1); COPADM3 #1 VCR 2 mg/m2 (max 2 mg) IV day 1; High-dose (HD) MTX 3 gm/m2 IV (over 3 hrs) day 1; MTX and HC each age adjusted IT day 2, 6 CTX 500 mg/m2/day (divided q12 hrs) IV day 2, 3, 4; Adriamycin 60 mg/m2 over 6 hrs IV; day 2; Prednisone 60 mg/m2 (divided bid) po day 1-5. G-CSF 5 mcg/kg/day starting day 7 until counts recover. COPADM3 #2 Like COPADM #1 (above) except: CTX - double dose (1 gm/m2/day) (divided q12 hr) VCR - second dose given on day 6 Consolidation- CYM x 2 courses HDMTX 3 gm/m2 (over 3 hr) IV Day 1; MTX plus HC each age adjusted IT day 2; Cytarabine (Ara-C) 100 mg/m2/day CI/IV (x 5 days) day 2-6; Ara-C and HC each age adjusted IT day 7. Maintenance Sequence 1 Prednisone 60 mg/m2/d (divided bid) PO day 1-5; HDMTX 3 gm/m2 (over 3 hr) IV Day 1; MTX plus HC each age adjusted IT day 2; CTX 500 mg/m2/day IV day 2, 3; Adriamycin 60 mg/m2 (over 6 hrs) IV day 3; VCR 2 mg/m2 (max 2 mg) IV day 1. G-CSF 5 mcg/kg/day starting day 6 until counts recover. Group C: B-ALL with >70% BM blasts; CNS involvement, Group B COP failures i.e., <20% reduction Treatment Pre-Induction Subjects will receive one week of treatment of COP as follows: CTX 300 mg/m2 IV day 1 VCR 1 mg/m2 (max 2 mg) IV day 1 Prednisone 60 mg/m2/d (divided) bid po day 1-7 MTX + HC + Ara-C each age adjusted IT day 1, 3, 5 Leucovorin 15 mg/m2 q12 hr x 2 po day 2, 4 Induction-COPADM x 2 Subjects will begin induction therapy the day after COP is finished as follows: COPADM8#1 VCR 2 mg/m2 (max 2 mg) IV day 1; HD MTX 8 gm/m2 (over 4 hrs) IV Day 1; MTX+HC+Ara-C each age adjusted IT day 1, 4, 6 (Ommaya, day 1); CTX 500 mg/m2/day divided every 12 hours IV day 2, 3, 4; Adriamycin 60 mg/m2 (over 6 hrs) IV day 2; Prednisone 60 mg/m2/day (divided bid) po/IV day 1-5. G-CSF 5 mcg/kg/day starting day 7 until counts recover. COPADM8 #2 Like COPAD M8 #1 except: CTX-double dose (1 gm/m2/day) (divided q12hs) IV VCR - 2nd dose given on day 6 Consolidation - CYVE x 2 courses Ara-C 50 mg/m2/12 hrs CI/IV Day 1-5; HD Ara-C 3 gm/m2/day IV over 3 hours Day 2-5; VP-16 200 mg/m2/day IV over 2 hours Day 2-5. Maintenance: Subjects will receive four courses of chemotherapy during continuation. Each course will use different chemotherapy drugs. Sequence 1 Prednisone 60 mg/m2/day (divided bid) po/IV day 1-5; HD MTX 8 gm/m2 (over 4 hrs) IV Day 1; MTX+HC+Ara-C each age adjusted IT day 2 (Ommaya, day 2) CTX 500 mg/m2 IV day 2, 3; Adriamycin 60 mg/m2 (over 6 hrs) IV day 3; VCR 2 mg/m2 (max 2 mg) IV day 1. G-CSF 5 mcg/kg/day starting day 7 until counts recover. Sequence 2 Ara-C 100 mg/m2/day (divided q12 hrs) SQ Day 1-5; VP-16 150 mg/m2/day (over 2 hrs) IV Days 1-3; G-CSF 5 micro g/kg SQ Days 6 until counts recovery; MTX+HC+Ara-C each age adjusted IT Day 1 (CNS positive, only) Ommaya Day 1 (CNS positive, only) Sequence 3 Prednisone 60 mg/m2/day (divided bid) po day 1-5; CTX 500 mg/m2/day IV day 1, 2; Adriamycin 60 mg/m2 (over 6 hrs) IV day 2; VCR 2 mg/m2 (max 2 mg) IV day 1; G-CSF 5 mcg/kg SQ starting day 6 until counts recover; MTX+HC+Ara-C each age adjusted IT Day 1 (CNS positive, only) Ommaya Day 1 (CNS positive, only). Sequence 4 Ara-C 100 mg/m2/day (divided q12 hrs) SQ Day 1-5; VP-16 150 mg/m2/day (over 2 hrs) IV Days 1-3; G-CSF 5 mcg/kg SQ days 6 until counts recover; MTX+HC+Ara-C each age adjusted IT Day 1 (CNS positive, only) Ommaya Day 1 (CNS positive, only) Intrathecal (IT) Treatment doses and volume are as follows: < than 1 year, MTX 8 mg, HC 8 mg, Ara C 15 mg, Volume 8 ml; Age 12-23 mo, MTX 10 mg, HC 10 mg, Ara C 20 mg, Volume 10 ml; Age 24-35 mo, MTX 12 mg, HC 12 mg, Ara C 25 mg, Volume 12 ml; Age ≥3 yr, MTX 15 mg, HC 15 mg, Ara C 30 mg. Volume 15 ml Ommaya Reservoir Treatment (CNS positive only) Age ≥3 yr, MTX 6 mg, HC 15 mg, Ara C 50 mg/m2 (50 mg max) Volume 3 ml

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Mature B-Cell
Keywords
Mature B-Cell Leukemia, Non-Hodgkin Lymphoma, Burkitt's lymphoma, Small noncleaved cell non Hodgkin lymphoma, Large cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Group A: Resected Stage I and resected abdominal Stage II Subjects will receive two courses (3 weeks apart) of COPAD.
Arm Title
B
Arm Type
Experimental
Arm Description
Group B: Other Stage II, Stage III, Stage IV or B-ALL M blast <70%; no CNS involvement. Subjects in Group B will receive one week of treatment of COP.
Arm Title
C
Arm Type
Experimental
Arm Description
Group C: B-ALL with >70% BM blasts; CNS involvement, Group B COP failures i.e., <20% reduction Treatment Pre-Induction Subjects will receive one week of treatment of COP.
Intervention Type
Drug
Intervention Name(s)
Prednison, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide, Doxorubicin
Intervention Description
The additional information is contained in the Detailed Description section.
Primary Outcome Measure Information:
Title
The purpose of this study is estimate the complete response, event-free survival, and overall survival in patients with small non-cleaved cell non-Hodgkin lymphoma or large cell NHL, or Burkitt leukemia/B-cell ALL treated with a modified LMP-89 regimen.
Time Frame
8-9 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject must be previously untreated, except for steroids. Subject must be less than or equal to 18 years of age. Subject must have a histologic diagnosis of small noncleaved cell (SNCC) NHL or large cell NHL (B-cell), or B-cell acute lymphocytic leukemia. Exclusion Criteria: Previously treated disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John T. Sandlund, M.D.
Organizational Affiliation
St. Jude Children's Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.stjude.org
Description
St. Jude Children's Research Hospital

Learn more about this trial

Treatment of Burkitt Lymphoma/Leukemia and B Large Cell NHL

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