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Rituximab and Combination Che...

Rituximab and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Last Updated: 2023-06-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-26

Study Completion Date

2019-03-31

Brief Summary

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RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large B-cell non-Hodgkin's lymphoma.

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Detailed Description

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OBJECTIVES:

Primary

* Determine the 2-year progression-free survival (PFS) rate after treatment with rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in patients with bulky stage II or stage III or IV diffuse large B-cell non-Hodgkin's lymphoma who remain positron emission tomography (PET)-positive after 3 courses of rituximab, cyclophosphamide, vincristine, doxorubicin hydrochloride, and prednisone.

Secondary

* Determine the proportion of mid-treatment PET-positive patients who become PET-negative after 4 courses of R-ICE.
* Determine the PFS of mid-treatment PET-negative patients treated with these regimens.
* Determine the overall survival of patients treated with these regimens.
* Determine the toxicity of these regimens in these patients.

OUTLINE:

* Rituximab and Combination Chemotherapy (R-CHOP: R= Rituximab, C= Cyclophosphamide, H= Doxorubicin Hydrochloride (Hydroxydaunomycin), O= Vincristine Sulfate (Oncovin), P= Prednisone): Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients undergo fludeoxyglucose F18 positron emission tomography (PET) scanning and conventional restaging during course 3. Based on the PET results, patients are assigned to 1 of 2 treatment groups.

* Group I (PET negative): Patients receive 2 more courses of R-CHOP as above in the absence of disease progression or unacceptable toxicity.
* Group II (PET positive): Patients receive Rituximab 375 mg/m2 IV Day 1, Ifosfamide 5000 mg/m2 IV over 24 hours Day 2, Carboplatin AUC 5 (max: 800 mg) IV Day 2, Etoposide 100 mg/m2 IV Days 1, 2, 3 (R-ICE), Mesna 5000 mg/m2 IV over 24 hours Day 2, and Filgrastim 5 mcg/kg/day subcutaneous (SC) Day 4 until absolute neutrophil count (ANC) recovery every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 10 years from the date of study entry.

ACCRUAL: A total of 100 patients were accrued for this study.

Conditions

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Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group I (PET negative)

Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

rituximab

Intervention Type BIOLOGICAL

Given IV

cyclophosphamide

Intervention Type DRUG

Given IV

doxorubicin hydrochloride

Intervention Type DRUG

Given IV

prednisone

Intervention Type DRUG

Taken orally

vincristine

Intervention Type DRUG

Given IV

Group II (PET positive)

Patients receive R-ICE comprising rituximab IV on day 1, ifosfamide IV continuously over 24 hours and carboplatin IV over 30 minutes on day 2, and etoposide IV over 2 hours on days 1-3. Patients also receive filgrastim (G-CSF) subcutaneously once daily starting on day 4 and continuing until blood counts recover. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

filgrastim

Intervention Type BIOLOGICAL

Given subcutaneously or intravenous bolus.

rituximab

Intervention Type BIOLOGICAL

Given IV

carboplatin

Intervention Type DRUG

Given IV

cyclophosphamide

Intervention Type DRUG

Given IV

etoposide

Intervention Type DRUG

Given IV

ifosfamide

Intervention Type DRUG

Given IV

Interventions

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filgrastim

Given subcutaneously or intravenous bolus.

Intervention Type BIOLOGICAL

rituximab

Given IV

Intervention Type BIOLOGICAL

carboplatin

Given IV

Intervention Type DRUG

cyclophosphamide

Given IV

Intervention Type DRUG

doxorubicin hydrochloride

Given IV

Intervention Type DRUG

etoposide

Given IV

Intervention Type DRUG

ifosfamide

Given IV

Intervention Type DRUG

prednisone

Taken orally

Intervention Type DRUG

vincristine

Given IV

Intervention Type DRUG

Other Intervention Names

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G-CSF, Neupogen, recombinant-methionyl human granulocyte-colony stimulating factor, granulocyte colony-stimulating factor, r-metHuG-CSF. IDEC-C2B8, Chimeric anti-CD20 monoclonal antibody, Rituxan. CBDCA, Paraplatin, JM-8, NSC #241240. Cytoxan, Neosar, CTX, CPM. Adriamycin, Rubex, Adriamycin RDF, Adriamycin PFS, hydroxydaunorubicin, hydroxydaunomycin, ADR. VP-16, VePesid, epipodophyllotoxin Isophosphamide, Ifex , Mitoxan , Holoxan , Naxamide ' NSC # 109724. Deltasone, Orasone, Medicorten, Panasol-S, Liquid-Pred, others. Oncovin, Vincasar PFS vincristine sulfate, VCR, leucocristine, LCR.

Eligibility Criteria

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Inclusion Criteria

* Diffuse large B-cell non-Hodgkin's lymphoma

* Bulky stage II (bulk defined as any lesion ≥ 10 cm) or stage III or IV disease
* The following lymphoma types are excluded:

* Primary central nervous system lymphoma
* Transformed low-grade lymphoma (prior history of low-grade lymphoma or clear presence of low-grade lymphoma on histologic sections)
* Primary mediastinal B-cell lymphoma or testicular lymphoma (consolidative radiotherapy is usually indicated)
* Immunodeficiency-related lymphoma (i.e., after organ or bone marrow transplant)
* Measurable disease

* Patient must have at least one objective measurable disease site (i.e., measurable in at least 2 perpendicular parameters)
* Measurable disease in the liver is required if the liver is the only site of lymphoma involvement
* Abnormal positron emission tomography scans will not constitute evaluable disease, unless verified by CT scan or other appropriate imaging
* Eastern Cooperative Oncology Group (ECOG) performance status 0-3
* For patients \> 50 years of age, a normal ejection fraction by ECHO or Multigated Acquisition Scan (MUGA) is required within 6 weeks prior to registration
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
* Creatinine \< 2.0 mg/dL
* Bilirubin \< 2 mg/dL (may be up to 3.0 mg/dL if due to liver involvement by lymphoma)

Exclusion Criteria

* Prior chemotherapy or radiation therapy for lymphoma
* Prior anthracyclines or platinum compounds used as systemic chemotherapy
* Prior radiation therapy to the mediastinum or to ≥ 25% of the bone marrow
* Concurrent pentostatin or trastuzumab (Herceptin®)
* Pregnant or nursing
* Prior malignancy within the past 5 years unless it was in situ OR was treated with curative intent AND the patient has remained relapse-free
* HIV positive

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lode J. Swinnen, MD

Role: STUDY_CHAIR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

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Veterans Affairs Medical Center - Palo Alto

Palo Alto, California, United States

Site Status

Front Range Cancer Specialists

Fort Collins, Colorado, United States

Site Status

Baptist Cancer Institute - Jacksonville

Jacksonville, Florida, United States

Site Status

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status

Rush-Copley Cancer Care Center

Aurora, Illinois, United States

Site Status

St. Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital

Canton, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

Site Status

Eureka Community Hospital

Eureka, Illinois, United States

Site Status

Evanston Northwestern Healthcare - Evanston Hospital

Evanston, Illinois, United States

Site Status

Galesburg Clinic, PC

Galesburg, Illinois, United States

Site Status

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois, United States

Site Status

Hopedale Medical Complex

Hopedale, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, United States

Site Status

McDonough District Hospital

Macomb, Illinois, United States

Site Status

Trinity Cancer Center at Trinity Medical Center - 7th Street Campus

Moline, Illinois, United States

Site Status

Moline, Illinois, United States

Site Status

BroMenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center

Normal, Illinois, United States

Site Status

Community Hospital of Ottawa

Ottawa, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, United States

Site Status

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

OSF St. Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois Valley Community Hospital

Peru, Illinois, United States

Site Status

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status

St. Margaret's Hospital

Spring Valley, Illinois, United States

Site Status

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Site Status

Saint Anthony Memorial Health Centers

Michigan City, Indiana, United States

Site Status

McFarland Clinic, PC

Ames, Iowa, United States

Site Status

Bettendorf, Iowa, United States

Site Status