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

NCT00610883 | Completed Phase 2 Results

• 1 other identifier: 90-042
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Conditions

Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete Remission

  The number of patients who achieved a complete remission as a result of treatment

  330 Days

Study Arms (1)

1 - LSA4

EXPERIMENTAL

Drug: LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU

Interventions

LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU DRUG

LSA4 intervention includes three phases: induction, consolidation and maintenance

1 - LSA4

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• B cell lymphomas, any primary site with initial LDH of less than 500 and initial CNS or bone involvement

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Cyclophosphamide; Methotrexate; Daunorubicin; Asparaginase; Carmustine

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Nitrosourea Compounds; Urea; Amides; Nitroso Compounds

Results Point of Contact

• Title: Dr. Tanya Trippett
• Organization: Memorial Sloan Kettering Cancer Center

trippet1@mskcc.org

212-639-8267

Study Officials

• Tanya Trippett, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: February 8, 2008
• Study Start: May 1, 1990
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 28, 2023
• Results First Posted: January 25, 2016

Record last verified: 2023-09

Locations

US (1)