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Study Summary
No. 2004-0305:.......Lymphoma......Alma [Lymphoma - VP Medical Affairs] Rodriguez......Lymphoma/Myeloma
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Study Summary Title
Study Summary
Number:
2004-0305
Study 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
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Physician New Patient Referral
Name:Alma [Lymphoma - VP Medical Affairs] RodriguezPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Lymphoma/MyelomaReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2860
Contact us about clinical trials
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General Information
Disease Group:LymphomaSupported By:N/A
Phase of Study:Phase IIReturn
Visit:
Patients will have up to 8 study visits.
Treatment
Agents:
Cyclophosphamide
Liposomal Doxorubicin
Prednisone
Home Care:N/A
Treatment Loc:MDACC + Community Programs (CCOP/Network)
Estimated
Length of Stay
in Houston:
No hospitalization is required for this study.
Description/
Intervention:
The goal of this clinical research study is to see if a new form of one of the
drugs in the standard chemotherapy is safer and more effective than the
original form. The new drug is pegylated liposomal doxorubicin, also called
liposomal doxorubicin.
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Study Objectives / Outcomes
Primary
    1. To determine the clinical response rate in patients older than 60 years of age with aggressive "B" cell lymphoma (B-cell lymphoma treated with a modification of rituximab, cyclophosphamide, hydroxyldaunorubicin [doxorubicin:Adriamycin], Oncovin [vincristine], and prednisone [RCHOP] in which the doxorubicin is replaced with pegylated liposomal doxorubicin.)

2. To determine whether the acceptable levels in cardiotoxicity and myelosuppression of the pegylated liposomal doxorubicin modification of RCHOP can be achieved in patients over 60 years of age.

Secondary
    1. To determine the disease free survival and overall survival of the patients enrolled on this trial.
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Study Status Information
Study Activation / Registration Date:06/21/2005
IRB Review and Approval Date:06/02/2004
Study Type:
Recruitment Status:Closed
Projected Accrual:80
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Histologically documented diagnosis of aggressive B-cell non-Hodgkin's lymphoma, including diffuse large B-cell lymphoma.

2) Measurable or evaluable disease, of stage II or greater, is required for study entry.

3) Previously untreated.

4) Age > 60 (i.e., >/= 61) years of age.

5) Adequate bone marrow reserve (ANC >1,000/ul, Platelets >100,000/ul), unless due to lymphoma-related hypersplenism or bone marrow infiltration.

6) Serum creatinine < 2 mg/dl, serum bilirubin < 2 mg/dl.

7) LVEF greater than or equal to 50% by echocardiogram.

8) Patients with known heart disease and Stage A Heart Failure are eligible for the trial at the discretion of the pts treating physician. It is strongly recommended that a consulting cardiologist review the pt. Patients with pre-existing hypertension and cardiac symptoms must be on well-controlled medication regimens. [Regardless of the cardiac status prior to treatment, consultation with a cardiologist is recommended before the second course of therapy for all pts.]

9) (Continuation from #8) Patients with known heart disease include those with diastolic dysfunciton, prior coronary artery bypass graft, percutanious transluminal coronary angioplasty or stent insertion, and prior radiation to the chest.

10) Zubrod performance status less than or equal to 2.

11) Signed informed consent

Exclusion Criteria:1) Primary central nervous system lymphoma and follicular B-cell lymphoma are excluded.

2) Excluded are patients with, myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities.

3) No psychiatric illness that precludes understanding concepts of the trial or signing informed consent.

4) No other major life-threatening illnesses that may preclude chemotherapy.

5) Patients who test positive/reactive for HBAg (Hepatitis B surface antigen), HbcAb (Hepatitis B core antibody), and Hepatitis C Virus Antibody. (Note: Patients vaccinated for Hepatitis who have positive antibodies are not excluded).

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Links
Registration Number: NCT00101010
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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