NCT00187070

Brief Summary

The main purpose of this study is to find out if it is feasible to deliver a multi-agent chemotherapy regimen which features a shorter, more intensive, immunophenotype-directed approach, and includes an intensification phase with hematopoietic stem cell support for children with large cell lymphoma

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 1997

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1997

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2001

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

May 7, 2008

Status Verified

May 1, 2008

Enrollment Period

3.6 years

First QC Date

September 12, 2005

Last Update Submit

May 6, 2008

Conditions

Lymphoma, Large CellLymphoma, Non-Hodgkin

Outcome Measures

Primary Outcomes (1)

  • To demonstrate the feasibility of delivery of a multiagent chemotherapy regimen which features a shorter, more direct approach, and includes a phase that incorporates hematopoietic stem cell support for children with large cell lymphoma.

    July 2001

Study Arms (1)

1

OTHER
Drug: Doxorubicin, Cotrimoxazole, Carboplatin, Ifosfamide, Dexamethasone, Prednisone, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide, VinblastineProcedure: Stem cell transplant,Radiation: Radiation Therapy

Interventions

Doxorubicin, Cotrimoxazole, Carboplatin, Ifosfamide, Dexamethasone, Prednisone, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide, VinblastineDRUG

See Detailed Description section for details of treatment interventions.

1
Stem cell transplant,PROCEDURE

See Detailed Description section for details of treatment interventions.

1
Radiation TherapyRADIATION

See Detailed Description section for details of treatment interventions.

1

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patient must be previously untreated, except for steroids or emergency radiation therapy.
  • Patient must be less than or equal to 18 years of age.
  • Patient must have a histologic diagnosis of large cell Non-Hodgkin lymphoma.
  • The immunophenotype of tumor cells must be either T-cell or non-B-cell, non-T-cell.

You may not qualify if:

  • Participants with B-cell immunophenotype NHL.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Reaearch Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

MeSH Terms

Conditions

Dendritic Cell Sarcoma, InterdigitatingLymphoma, Non-Hodgkin

Interventions

DoxorubicinTrimethoprim, Sulfamethoxazole Drug CombinationCarboplatinIfosfamideDexamethasonePrednisoneVincristineCytarabineMethotrexateEtoposideCyclophosphamideVinblastineStem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Histiocytic Disorders, MalignantNeoplasms by Histologic TypeNeoplasmsHistiocytosisLymphatic DiseasesHemic and Lymphatic DiseasesLymphomaLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesSulfamethoxazoleBenzenesulfonamidesSulfonamidesAmidesSulfanilamidesAniline CompoundsAminesBenzene DerivativesSulfonesSulfur CompoundsTrimethoprimPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical PreparationsCoordination ComplexesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsOxazinesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsSteroids, FluorinatedPregnadienediolsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesCytidinePyrimidine NucleosidesArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesAminopterinPterinsPteridinesPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosidesCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • John T. Sandlund, M.D.

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

December 1, 1997

Primary Completion

July 1, 2001

Study Completion

July 1, 2001

Last Updated

May 7, 2008

Record last verified: 2008-05

Locations

US(1)