NCT00039195

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy, total-body irradiation, and peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: This phase II trial is studying how well giving chemotherapy with rituximab followed by combination chemotherapy with or without rituximab, total-body irradiation, and peripheral stem cell transplant works in treating patients with lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P75+ for phase_2 lymphoma

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_2 lymphoma

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

First Submitted

Initial submission to the registry

June 6, 2002

Completed
8 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.8 years until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
6.6 years until next milestone

Results Posted

Study results publicly available

August 10, 2016

Completed
Last Updated

August 10, 2016

Status Verified

June 1, 2016

Enrollment Period

3.2 years

First QC Date

June 6, 2002

Results QC Date

December 15, 2015

Last Update Submit

June 29, 2016

Conditions

Lymphoma

Keywords

stage I adult diffuse large cell lymphomastage III adult diffuse large cell lymphomastage IV adult diffuse large cell lymphomacontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse large cell lymphoma

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    Kaplan-Meier estimates will be used to verify the progression free survival.

    2 years

Study Arms (1)

Induction R-CHOPac Therapy for patients with B-Cell Lymphoma

EXPERIMENTAL

Patients received 4 cycles if accelerated R-CHOP (cyclophosphamide. doxorubicin, vincristine and prednisone + rituximab) followed by 3 cycles ICE (ifosfamide, carboplatin and etoposide) consolidation therapy.

Biological: filgrastimBiological: rituximabDrug: carboplatinDrug: cyclophosphamideDrug: doxorubicin hydrochlorideDrug: etoposideDrug: ifosfamideDrug: prednisoneDrug: vincristine sulfateProcedure: peripheral blood stem cell transplantationRadiation: radiation therapy

Interventions

filgrastimBIOLOGICAL
Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
rituximabBIOLOGICAL
Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
carboplatinDRUG
Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
cyclophosphamideDRUG
Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
doxorubicin hydrochlorideDRUG
Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
etoposideDRUG
Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
ifosfamideDRUG
Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
prednisoneDRUG
Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
vincristine sulfateDRUG
Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
peripheral blood stem cell transplantationPROCEDURE
Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
radiation therapyRADIATION
Induction R-CHOPac Therapy for patients with B-Cell Lymphoma

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
DISEASE CHARACTERISTICS: * Histologically confirmed aggressive diffuse large B-cell lymphoma * CD20-positive disease * Age-adjusted International Prognostic Index II or III defined by the presence of at least 1 of the following: * Karnofsky performance status 10-70% * Lactate dehydrogenase greater than 200 U/L * Stage III or IV disease * Positron emission tomography avid measurable disease * No CNS involvement PATIENT CHARACTERISTICS: Age: * 18 to 64 Performance status: * See Disease Characteristics Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 1,000/mm\^3 * Platelet count greater than 50,000/mm\^3 Hepatic: * Bilirubin less than 2.0 mg/dL unless history of Gilbert's disease or pattern consistent with Gilbert's disease * Hepatitis B surface antigen and hepatitis C antibody negative * No chronic, active, or persistent hepatitis Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min * No chronic renal insufficiency Cardiovascular: * Ejection fraction at least 50% by echocardiogram or MUGA scan * No myocardial infarction within the past 6 months * No unstable angina * No cardiac arrhythmias except chronic atrial fibrillation Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception * HIV negative * No other medical illness that would preclude study * No uncontrolled infection * No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic therapy for malignancy Chemotherapy: * No prior chemotherapy for malignancy Endocrine therapy: * Prior steroids allowed if received no more than 1 week of therapy Radiotherapy: * No prior radiotherapy for malignancy Surgery: * No prior surgery for malignancy Other: * No other prior therapy for malignancy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

  • Bantilan KS, Smith AN, Maurer MJ, Teruya-Feldstein J, Matasar MJ, Moskowitz AJ, Straus DJ, Noy A, Palomba ML, Horwitz SM, Hamlin PA, Portlock CS, Cerhan JR, Habermann TM, Salles GA, Nowakowski GS, Moskowitz CH, Zelenetz AD. Matched control analysis suggests that R-CHOP followed by (R)-ICE may improve outcome in non-GCB DLBCL compared with R-CHOP. Blood Adv. 2024 May 14;8(9):2172-2181. doi: 10.1182/bloodadvances.2023011408.

    PMID: 38271621DERIVED

MeSH Terms

Conditions

LymphomaLymphoma, Large B-Cell, Diffuse

Interventions

FilgrastimRituximabCarboplatinCyclophosphamideDoxorubicinEtoposideIfosfamidePrednisoneVincristinePeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsSerum GlobulinsGlobulinsCoordination ComplexesOrganic ChemicalsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosidesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Results Point of Contact

Title
Dr. Craig Moskowitz
Organization
Memorial Slaon Kettering
moskowic@mskcc.org
212-639-7992

Study Officials

  • Craig Moskowitz, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2002

First Posted

January 27, 2003

Study Start

November 1, 2006

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

August 10, 2016

Results First Posted

August 10, 2016

Record last verified: 2016-06

Locations

US(1)