Phase 2 N=80 Treatment

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

Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT00101010 ↗

Enrolled (actual)

Serious AEs

1.3%

Results posted

Oct 2020

Primary outcome: Primary: Disease Response (Complete, Complete Unconfirmed, and Partial Responses) After 4 Courses — 47; 8; 14 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Filgrastim (Biological); Pegfilgrastim (Biological); Rituximab (Biological); Cyclophosphamide (Drug); Pegylated liposomal doxorubicin hydrochloride (Drug); Prednisone (Drug); Vincristine Sulfate (Drug)
Age: Adult, Older Adult · 61+ yrs
Sex: All
Sponsor: M.D. Anderson Cancer Center
Primary completion: Sep 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Disease Response (Complete, Complete Unconfirmed, and Partial Responses) After 4 Courses	47; 8; 14	—
PRIMARY Number of Participants Experienced Grade 3 or Higher Cardiac Toxicity After Treatment: Cardiac Toxicity as Measured by Left Ventricular Ejection Fraction (LVEF) on Echocardiogram (ECHO) After 8 Courses	10	—
SECONDARY Survival Rate	—	—
SECONDARY Disease-free Survival	—	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00101010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.