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CompletedNCT00610883Updated Sep 28, 2023Results posted

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

A Phase 2 interventional study of LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU in Non-Hodgkin's Lymphoma, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2023-09-28.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
Up to 21 Years
Sex
All
01

Study 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
02

Conditions studied

  • Non-Hodgkin's Lymphoma
03

In context

Lymphoma, Non-Hodgkin

2,043 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 309 are open to participants now.

This study's enrollment of 17 is below the median of 40 across 1,744 interventional studies indexed under Lymphoma, Non-Hodgkin.

Browse Lymphoma, Non-Hodgkin studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,957 studies on the registry; 323 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 68 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • B cell lymphomas, any primary site with initial LDH of less than 500 and initial CNS or bone involvement
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    1 - LSA4

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

Interventions

  • DrugLSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU

    LSA4 intervention includes three phases: induction, consolidation and maintenance

06

What researchers measure

Primary outcomes

  1. Complete Remission

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

    Time frame: 330 Days

07

Results

Posted Jan 25, 2016

Participant flow

Participant flow — Overall Study
MilestoneAll Patients
Started17
Completed17
Not completed0

Outcome measures

PrimaryComplete Remission

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

Time frame:
330 Days
Reported as:
Number · participants
Complete Remission
participantsAll Patients
Complete Remission10

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
All Patients—1/17 (5.9%)17/17 (100%)
Most frequent serious events
Most frequent serious events
EventAll Patients
Ruptured Necrotic TumorCardiac disorders1/17
Most frequent other events
Most frequent other events
EventAll Patients
Hematological ToxicityBlood and lymphatic system disorders17/17
Hepatic ToxicityRenal and urinary disorders17/17

Baseline characteristics

Age, Customized
Age, Customized(years)All Patients
Median Age12 (2 to 19)
Sex: Female, Male
Sex: Female, Male(Participants)All Patients
Female5
Male12
08

Study locations

1 site
  • Memorial Sloan-Kettering Cancer Center
    New York, New York 10065, United States
09

References and documents

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 1990, a primary completion of Dec 2008 and a completion of Dec 2008. It does not say whether these dates are actual or estimated.

Results were first posted in Jan 2016, 7 years 1 month after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 26, 2007
First posted
Feb 8, 2008
Start
May 1990
Primary completionActual
Dec 2008
CompletionActual
Dec 2008
Results first posted
Jan 25, 2016
Last update
Sep 28, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00610883
Responsible party
Sponsor
First posted
Feb 8, 2008
Start date
May 1990
Primary completion
Dec 2008
Completion
Dec 2008
Results posted
Jan 25, 2016
Last update
Sep 28, 2023

Study contacts

Tanya Trippett, MD
principal investigator · Memorial Sloan Kettering Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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