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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00101010
First received: January 7, 2005
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Lymphoma
Biological: Filgrastim
Biological: Pegfilgrastim
Biological: Rituximab
Drug: Cyclophosphamide
Drug: Pegylated liposomal doxorubicin hydrochloride
Drug: Prednisone
Drug: vincristine sulfate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Rituximab-CHOP With Pegylated Liposomal Doxorubicin In Patients Older Than 60 Years Of Age With Untreated Aggressive B-Cell Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Disease response (complete, complete unconfirmed, and partial responses) after courses 4 and 8 [ Time Frame: Up to 24 weeks (8 cycles of 21 days) ] [ Designated as safety issue: No ]
  • Cardiac toxicity as measured by LVEF on ECHO after courses 4 and 8 [ Time Frame: Up to 24 weeks (8 cycles of 21 days) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Survival Rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    The percentage of participants still alive after treatment. Survival information obtained 1 month after completion of treatment, then every 3 months for 1 year, every 4 months for one year and every 6 months thereafter.

  • Disease-free survival [ Time Frame: Up to 5 years or until disease progression ] [ Designated as safety issue: No ]
    The percentage of participants with no disease progression for period of time after treatment. Survival assessed every 3 months for 1 year, every 4 months for 2 years, every 6 months for 3 years, and then yearly thereafter up to 5 years.


Estimated Enrollment: 80
Study Start Date: September 2005
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab - Combination Chemotherapy
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
Biological: Filgrastim
5 mcg/kg, SC daily, start 24 hours after chemotherapy
Other Names:
  • G-CSF
  • Neupogen
Biological: Pegfilgrastim
6 mg SC one time (24 hours after chemotherapy)
Other Names:
  • Neulasta
  • PEG-G-CSF
Biological: Rituximab
375 mg/m^2 intravenous piggy back (IVPB) on day 1, administered 1st
Other Name: Rituxan
Drug: Cyclophosphamide
750 mg/m^2 IVPB on day 1
Other Names:
  • Cytoxan
  • Neosar
Drug: Pegylated liposomal doxorubicin hydrochloride
40 mg/m^2 IV (maximum dose 90 mg) infusion over 1 hour on day 1
Other Names:
  • Caelyx
  • Doxil
  • liposomal doxorubicin
  • doxorubicin hydrochloride
  • liposomal doxorubicin hydrochloride
Drug: Prednisone
40 mg/m^2 oral days 1 - 5.
Drug: vincristine sulfate
2 mg IV, day 1

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.

  Eligibility

Ages Eligible for Study:   61 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00101010

Locations
United States, Arkansas
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, Arkansas, United States, 72913
United States, Michigan
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
United States, Missouri
Cancer Research for the Ozarks
Springfield, Missouri, United States, 65804
United States, New York
Hematology Oncology Associates of Central New York, PC - Northeast Center
East Syracuse, New York, United States, 13057-4510
United States, South Carolina
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, Texas
University of Texas M.D. Anderson CCOP Research Base
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Maria A. Rodriguez, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00101010     History of Changes
Obsolete Identifiers: NCT00290446
Other Study ID Numbers: CDR0000407533, MDA-CCOP-2004-0305, NCI-6485, 2004-0305
Study First Received: January 7, 2005
Last Updated: October 29, 2013
Health Authority: United States: Federal Government

Keywords provided by M.D. Anderson Cancer Center:
contiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
stage III adult diffuse large cell lymphoma
stage IV adult diffuse large cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
Rituximab
Doxorubicin
Prednisone
Vincristine
Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on July 23, 2014