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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00610883
Recruitment Status : Completed
First Posted : February 8, 2008
Results First Posted : January 25, 2016
Last Update Posted : January 25, 2016
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LSA4 Protocol for the Treatment of Advanced Pediatric and Adolescent Non-Hodgkins Lymphoma
Study Start Date : May 1990
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 - LSA4 Drug: LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU
LSA4 intervention includes three phases: induction, consolidation and maintenance


Outcome Measures
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Primary Outcome Measures :
  1. Complete Remission [ Time Frame: 330 Days ]
    The number of patients who achieved a complete remission as a result of treatment


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00610883


Locations
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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Tanya Trippett, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00610883    
Other Study ID Numbers: 90-042
First Posted: February 8, 2008    Key Record Dates
Results First Posted: January 25, 2016
Last Update Posted: January 25, 2016
Last Verified: December 2015
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Methotrexate
Asparaginase
Daunorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors