NCT01539174

Brief Summary

This phase II trial studies how well giving rituximab together with combination chemotherapy works in treating patients with previously untreated high- or high-intermediate-risk diffuse large B-cell lymphoma (DLBCL). Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (CHOP), work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug, combination chemotherapy, may kill more cancer cells. Giving rituximab together with combination chemotherapy together may be an effective treatment for DLBCL

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 27, 2012

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

First QC Date

February 15, 2012

Last Update Submit

March 1, 2016

Conditions

Contiguous Stage II Adult Diffuse Large Cell LymphomaNoncontiguous Stage II Adult Diffuse Large Cell LymphomaStage I Adult Diffuse Large Cell LymphomaStage III Adult Diffuse Large Cell LymphomaStage IV Adult Diffuse Large Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • PFS following treatment with rituximab intense dosing and CHOP-21 in previously untreated patients with high risk DLBCL

    Defined as the time from entry onto study until lymphoma progression or death from any cause.

    1 year

Secondary Outcomes (1)

  • CR in previously untreated patients with high risk DLBCL treated with rituximab intense dosing and CHOP-21

    Baseline, between days 15 and 21 of course 3, and within 20-35 days after completion of treatment

Study Arms (1)

Treatment (monoclonal antibody, combination chemotherapy)

EXPERIMENTAL

Patients receive rituximab IV on days 0, 1, 4, 8, and 15 of course 1; days 1, 8, and 15 of course 2; and day 1 of all subsequent courses. Patients also receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Biological: rituximabDrug: cyclophosphamideDrug: doxorubicin hydrochlorideDrug: vincristine sulfateDrug: prednisoneOther: laboratory biomarker analysisOther: pharmacological study

Interventions

rituximabBIOLOGICAL

Given IV

Also known as: IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8, Rituxan
Treatment (monoclonal antibody, combination chemotherapy)
cyclophosphamideDRUG

Given IV

Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana
Treatment (monoclonal antibody, combination chemotherapy)
doxorubicin hydrochlorideDRUG

Given IV

Also known as: ADM, ADR, Adria, Adriamycin PFS, Adriamycin RDF
Treatment (monoclonal antibody, combination chemotherapy)
vincristine sulfateDRUG

Given IV

Also known as: leurocristine sulfate, VCR, Vincasar PFS
Treatment (monoclonal antibody, combination chemotherapy)
prednisoneDRUG

Given PO

Also known as: DeCortin, Deltra
Treatment (monoclonal antibody, combination chemotherapy)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (monoclonal antibody, combination chemotherapy)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (monoclonal antibody, combination chemotherapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed cluster of differentiation (CD) 20+ DLBCL with IPI between 3-5
  • No prior chemotherapy, radiation therapy or immunotherapy for DLBCL; a short course (\< 2 weeks) of corticosteroids is allowed for symptom control Signed informed consent
  • Eastern Cooperative Oncology Group (ECOG) Performance status assessed between 0 and 2; performance status of 3 will be accepted if impairment is caused by DLBCL complications and improvement is expected once therapy is initiated
  • Measurable disease by Non-Hodgkin's Lymphoma Response Criteria on FDG-PET/CT; baseline measurements and evaluations must be obtained =\< 21 days prior to registration
  • Absolute neutrophil count (ANC) \>= 1,500/μL unless due to marrow involvement by lymphoma
  • Platelets \>= 75,000/μL unless due to marrow involvement by lymphoma Hemoglobin \> 7.0 g/dL unless due to marrow involvement by lymphoma
  • Creatinine =\< 2.0 mg/dL or calculated creatinine clearance \>= 40
  • Total bilirubin =\< 1.5 mg/dL unless due to Gilbert's disease
  • Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) =\< 2.5 the upper limit of normal
  • Alkaline phosphatase =\< 5x upper limit of normal
  • Patients with bilirubin between 1.5-3.0 mg/dL due to lymphoma may be entered and doses adjusted
  • Left ventricular ejection fraction (LVEF) \>= 50%

You may not qualify if:

  • Women who are pregnant or breast feeding
  • Known seropositivity for human immunodeficiency virus (HIV)
  • Known presence of central nervous system (CNS) involvement by lymphoma
  • New York Heart Association Classification III or IV heart
  • Current or chronic hepatitis B or hepatitis C infection (as detected by positive testing for Hepatitis B surface Antigen \[Hbs Ag\] or antibody to Hepatitis C virus \[anti HCV\] respectively); patients must be tested for Hepatitis B surface antigen and anti-HCV =\< 21 days prior to registration
  • Male patients (with female sexual partners of childbearing potential) and female patients of childbearing potential who refuse to use effective methods of contraception
  • Unstable or severe uncontrolled medical, psychological, or social condition
  • Any evidence of serious active, uncontrolled infection (i.e., requiring an IV antibiotic or antiviral agent)
  • Receipt of live vaccine within 4 weeks prior to study drug administration
  • Concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix; subjects with previous malignancies are eligible provided that they have been treated with curative intent and remain disease free for 3 years or more
  • No prior chemotherapy for lymphoma
  • Prior radiation therapy for lymphoma
  • Any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, significantly increase the subject's risk of participating in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

RituximabCyclophosphamideDoxorubicinVincristinePrednisone

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring Compounds

Study Officials

  • Michael Millenson, MD, FACP

    Fox Chase Cancer Center

    PRINCIPAL INVESTIGATOR
0

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

February 15, 2012

First Posted

February 27, 2012

Last Updated

March 3, 2016

Record last verified: 2016-03

Locations

US(1)