Back to resultsLSA4 Protocol for the Treatment of Advanced Pediatric and Adolescent Non-Hodgkins Lymphoma
Primary Purpose
Non-Hodgkin's Lymphoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU
Sponsored by
About this trial
This is an interventional treatment trial for Non-Hodgkin's Lymphoma
Eligibility Criteria
Inclusion Criteria:
Non-Hodgkin's Lymphoma stages III, IV, IVA with
- T cell lymphomas, any primary site irrespective of LDH level
- large cell lymphomas, any primary site irrespective of LDH level
- B cell lymphomas, any primary site with initial LDH of less than 500
Exclusion Criteria:
- B cell lymphomas, any primary site with initial LDH of less than 500 and initial CNS or bone involvement
Sites / Locations
- Memorial Sloan-Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1 - LSA4
Arm Description
Outcomes
Primary Outcome Measures
Complete Remission
The number of patients who achieved a complete remission as a result of treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT00610883
First Posted
December 26, 2007
Last Updated
September 22, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00610883
Brief Title
LSA4 Protocol for the Treatment of Advanced Pediatric and Adolescent Non-Hodgkins Lymphoma
Official Title
LSA4 Protocol for the Treatment of Advanced Pediatric and Adolescent Non-Hodgkins Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 1990 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
5. Study Description
Brief Summary
Non-Hodgin's lymphoma is curable in 76% of patients. In nonlymphoblastic lymphmas, cancer may return on average 3 months from beginning treatment and for lymphoblastic lymphomas, 6 months. To aggressively treat this cancer this study uses effective drugs in three parts:
Induction ends on day 19
Consolidation ends on day 38 or 42
Maintenance may include up to 6 cycles
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 - LSA4
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU
Intervention Description
LSA4 intervention includes three phases: induction, consolidation and maintenance
Primary Outcome Measure Information:
Title
Complete Remission
Description
The number of patients who achieved a complete remission as a result of treatment
Time Frame
330 Days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non-Hodgkin's Lymphoma stages III, IV, IVA with
T cell lymphomas, any primary site irrespective of LDH level
large cell lymphomas, any primary site irrespective of LDH level
B cell lymphomas, any primary site with initial LDH of less than 500
Exclusion Criteria:
B cell lymphomas, any primary site with initial LDH of less than 500 and initial CNS or bone involvement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanya Trippett, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan-Kettering Cancer Center
Learn more about this trial
LSA4 Protocol for the Treatment of Advanced Pediatric and Adolescent Non-Hodgkins Lymphoma
We'll reach out to this number within 24 hrs