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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


Phase 2
61 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease response (complete, complete unconfirmed, and partial responses) after courses 4 and 8

Outcome Time Frame:

Up to 24 weeks (8 cycles of 21 days)

Safety Issue:

No

Principal Investigator

Maria A. Rodriguez, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000407533

NCT ID:

NCT00101010

Start Date:

September 2005

Completion Date:

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

Name

Location

CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - KalamazooKalamazoo, Michigan  49007-3731
Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Hembree Mercy Cancer Center at St. Edward Mercy Medical CenterFt. Smith, Arkansas  72903
University of Texas M.D. Anderson CCOP Research BaseHouston, Texas  77030-4009
Hematology Oncology Associates of Central New York, PC - Northeast CenterEast Syracuse, New York  13057-4510