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

This study has been completed.
Sponsor:
Collaborators:
Ortho Biotech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00101010
First received: January 7, 2005
Last updated: September 10, 2014
Last verified: September 2014

January 7, 2005
September 10, 2014
September 2005
September 2014   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00101010 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
Rituximab and Combination Chemotherapy in Treating Older Patients With Diffuse Large B-Cell Lymphoma
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

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
  • 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
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
Interventions:
  • Biological: Filgrastim
  • Biological: Pegfilgrastim
  • Biological: Rituximab
  • Drug: Cyclophosphamide
  • Drug: Pegylated liposomal doxorubicin hydrochloride
  • Drug: Prednisone
  • Drug: Vincristine Sulfate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
Not Provided
September 2014   (final data collection date for primary outcome measure)

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
Both
61 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00101010
CDR0000407533, MDA-CCOP-2004-0305, NCI-6485, 2004-0305, NCI-2009-00064, 2 U10 CA45809
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)
  • Ortho Biotech, Inc.
Study Chair: Maria A. Rodriguez, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP