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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00610883
Enrollment
17
Registered
2008-02-08
Start date
1990-05-31
Completion date
2008-12-31
Last updated
2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hodgkin's Lymphoma

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

Interventions

DRUGLSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU

LSA4 intervention includes three phases: induction, consolidation and maintenance

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Complete Remission330 DaysThe number of patients who achieved a complete remission as a result of treatment

Countries

United States

Participant flow

Participants by arm

ArmCount
All Patients
LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance
17
Total17

Baseline characteristics

CharacteristicAll Patients
Age, Customized
Median Age
12 years
Sex: Female, Male
Female
5 Participants
Sex: Female, Male
Male
12 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
17 / 17
serious
Total, serious adverse events
1 / 17

Outcome results

Primary

Complete Remission

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

Time frame: 330 Days

ArmMeasureValue (NUMBER)
All PatientsComplete Remission10 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026