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

September 22, 2023 updated by: Memorial Sloan Kettering Cancer Center

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

Study Overview

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 - LSA4
LSA4 intervention includes three phases: induction, consolidation and maintenance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Remission
Time Frame: 330 Days
The number of patients who achieved a complete remission as a result of treatment
330 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Tanya Trippett, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1990

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

February 7, 2008

First Posted (Estimated)

February 8, 2008

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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