Rituximab and Combination Chemotherapy in Treating Older Patients With Diffuse Large B-Cell Lymphoma

NCT ID: NCT00101010

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2014-09-30

Brief Summary

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 older patients with diffuse large B-cell lymphoma.

Detailed Description

OBJECTIVES:

Primary

• Determine the clinical response rate in older patients with previously untreated aggressive diffuse large B-cell stage II-IV lymphoma treated with rituximab, cyclophosphamide, pegylated doxorubicin hydrochloride liposome (HCl), vincristine, and prednisone.
• Determine the cardiotoxicity and myelosuppression of this regimen in these patients.

Secondary

• Determine disease-free survival and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive rituximab intravenous (IV), cyclophosphamide IV over 1-1½ hours, pegylated doxorubicin HCl liposome IV over 1 hour, and vincristine IV on day 1, and oral prednisone on days 1-5. Patients also receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 6 and continuing until blood counts recover OR pegfilgrastim SC once on day 6 (24 hours after the completion of chemotherapy). Treatment repeats every 21 days for up to 8 courses in the absence of unacceptable toxicity, disease progression, active hepatitis B virus infection, or hepatitis. Patients with no response OR who achieve less than a partial response after 4 courses are removed from the study.

Patients are followed at 1 month, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.

PROJECTED ACCRUAL: A maximum of 80 patients will be accrued for this study within 27 months.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rituximab - Combination Chemotherapy

Rituximab 375 mg/m\^2 intravenous (IV), Cyclophosphamide IV over 1-1½ hours, Pegylated doxorubicin HCl liposome 40 mg/m\^2 IV over 1 hour, Vincristine 2 mg IV, day 1, \& oral Prednisone 40 mg/m\^2 days 1 - 5; Filgrastim (G-CSF) 5 mcg/kg subcutaneously (SC) once daily beginning day 6 continuing until blood counts recover OR Pegfilgrastim 6 mg SC once on day 6 (24 hours after chemotherapy). Treatment repeats every 21 days for up to 8 courses.

Group Type: EXPERIMENTAL

Filgrastim

Intervention Type: BIOLOGICAL

5 mcg/kg, SC daily, start 24 hours after chemotherapy

Pegfilgrastim

Intervention Type: BIOLOGICAL

6 mg SC one time (24 hours after chemotherapy)

Rituximab

Intervention Type: BIOLOGICAL

375 mg/m\^2 intravenous piggy back (IVPB) on day 1, administered 1st

Cyclophosphamide

Intervention Type: DRUG

750 mg/m\^2 IVPB on day 1

Pegylated liposomal doxorubicin hydrochloride

Intervention Type: DRUG

40 mg/m\^2 IV (maximum dose 90 mg) infusion over 1 hour on day 1

Prednisone

Intervention Type: DRUG

40 mg/m\^2 oral days 1 - 5.

Vincristine Sulfate

Intervention Type: DRUG

2 mg IV, day 1

Interventions

Filgrastim

5 mcg/kg, SC daily, start 24 hours after chemotherapy

Intervention Type: BIOLOGICAL

Pegfilgrastim

6 mg SC one time (24 hours after chemotherapy)

Intervention Type: BIOLOGICAL

Rituximab

375 mg/m\^2 intravenous piggy back (IVPB) on day 1, administered 1st

Intervention Type: BIOLOGICAL

Cyclophosphamide

750 mg/m\^2 IVPB on day 1

Intervention Type: DRUG

Pegylated liposomal doxorubicin hydrochloride

40 mg/m\^2 IV (maximum dose 90 mg) infusion over 1 hour on day 1

Intervention Type: DRUG

Prednisone

40 mg/m\^2 oral days 1 - 5.

Intervention Type: DRUG

Vincristine Sulfate

2 mg IV, day 1

Intervention Type: DRUG

Other Intervention Names

G-CSF; Neupogen; Neulasta; PEG-G-CSF; Rituxan; Cytoxan; Neosar; Caelyx; Doxil; liposomal doxorubicin; doxorubicin hydrochloride; liposomal doxorubicin hydrochloride

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed diffuse large B-cell lymphoma

• Stage II, III, or IV disease
• Previously untreated disease
• Measurable or evaluable disease
• No primary central nervous system (CNS) lymphoma or follicular B-cell lymphoma

PATIENT CHARACTERISTICS:

Age

• 61 and over

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count > 1,000/mm^3*
• Platelet count > 100,000/mm^3* NOTE: * Unless due to lymphoma-related hypersplenism or bone marrow infiltration

Hepatic

• Bilirubin < 2 mg/dL
• Hepatitis B surface antigen negative
• Hepatitis B core antibody negative
• Hepatitis C Virus antibody negative

Renal

• Creatinine < 2 mg/dL

Cardiovascular

• left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or ple gated acquisition (MUGA) scan
• No uncontrolled hypertension or cardiac symptoms
• Cardiologist consultation required for patients with stage A cardiac failure or any of the following known heart diseases:

• Diastolic dysfunction
• Prior coronary artery bypass graft
• Prior percutaneous transluminal coronary angioplasty
• Prior stent insertion
• Prior radiotherapy to the chest
• No myocardial infarction within the past 6 months
• No New York Heart Association class II-IV heart failure
• No uncontrolled angina
• No severe uncontrolled ventricular arrhythmias
• No clinically significant pericardial disease
• No acute ischemic or active conduction system abnormality by electrocardiogram (EKG)

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No psychiatric illness that would preclude study compliance or giving informed consent
• No other major life-threatening illness that would preclude study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• See Cardiovascular

Surgery

• See Cardiovascular

• Minimum Eligible Age: 61 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Ortho Biotech, Inc.

INDUSTRY

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria A. Rodriguez, MD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Locations

Hembree Mercy Cancer Center at St. Edward Mercy Medical Center

Fort Smith, Arkansas, United States

CCOP - Grand Rapids

Grand Rapids, Michigan, United States

CCOP - Kalamazoo

Kalamazoo, Michigan, United States

Cancer Research for the Ozarks

Springfield, Missouri, United States

Hematology Oncology Associates of Central New York, PC - Northeast Center

East Syracuse, New York, United States

CCOP - Upstate Carolina

Spartanburg, South Carolina, United States

University of Texas M.D. Anderson CCOP Research Base

Houston, Texas, United States

Countries

United States

Other Identifiers

MDA-CCOP-2004-0305

Identifier Type: -

Identifier Source: secondary_id

NCI-6485

Identifier Type: -

Identifier Source: secondary_id

2004-0305

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2009-00064

Identifier Type: REGISTRY

Identifier Source: secondary_id

2U10CA045809

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000407533

Identifier Type: -

Identifier Source: org_study_id

NCT00290446

Identifier Type: -

Identifier Source: nct_alias