Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

LSA4 Protocol for the Treatment of Advanced Pediatric and Adolescent Non-Hodgkins Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00610883
First received: December 26, 2007
Last updated: December 21, 2015
Last verified: December 2015

December 26, 2007
December 21, 2015
May 1990
December 2008   (final data collection date for primary outcome measure)
Complete Remission [ Time Frame: 330 Days ] [ Designated as safety issue: No ]
The number of patients who achieved a complete remission as a result of treatment
Non-Hodgkin Cancer does not return 3 years after completing treatment [ Time Frame: 330 Days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00610883 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
LSA4 Protocol for the Treatment of Advanced Pediatric and Adolescent Non-Hodgkins Lymphoma
LSA4 Protocol for the Treatment of Advanced Pediatric and Adolescent Non-Hodgkins Lymphoma

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
Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma
Drug: LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU
LSA4 intervention includes three phases: induction, consolidation and maintenance
Experimental: 1 - LSA4
Intervention: Drug: LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Non-Hodgkin's Lymphoma stages III, IV, IVA with

    1. T cell lymphomas, any primary site irrespective of LDH level
    2. large cell lymphomas, any primary site irrespective of LDH level
    3. 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
Both
up to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00610883
90-042
Not Provided
Not Provided
Not Provided
Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
Not Provided
Principal Investigator: Tanya Trippett, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP