Phase 2 Completed N=82 Treatment

Rituximab and ABVD for Hodgkin's Patients

Source: ClinicalTrials.gov NCT00504504 ↗

Enrolled (actual)

Serious AEs

48.8%

Results posted

Jul 2013

Primary outcomePrimary: 5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD — 83 percentage of participants

Summary

Primary Objective: - To determine the feasibility, toxicity, and efficacy of Rituximab with standard dose ABVD combination chemotherapy. ABVD combination chemotherapy consists of Adriamycin, Bleomycin, Vinblastine and DTIC.

Outcome Measures

Outcome	Result	p-value
PRIMARY 5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD	83	—

Eligibility Criteria

Inclusion Criteria

Hodgkin's disease patients who relapse after radiation therapy alone and previously untreated patients with stage II bulky, III and IV who are eligible for ABVD.
Must have histologically proven diagnosis of Hodgkin's disease (Nodular sclerosis or mixed cellularity).
Must have bidimensionally measurable disease.
Must sign a consent form.
Must be older than 16 years of age.
Must have adequate bone marrow reserve (ANC > 1,000/microL, Platelet > 100,000/microL
Left Ventricular Ejection Fraction (LVEF) >/= 50% by multigated acquisition (MUGA) scan or echocardiogram.
Serum creatinine < 2 mg/dl, serum bilirubin < 2 mg/dl

Exclusion Criteria

HIV positive.
Pregnant women and women of child bearing age who are not practicing adequate contraception.
Prior chemotherapy.
Severe pulmonary disease including Chronic obstructive pulmonary disease (COPD) and asthma.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00504504). 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. Informational only — not medical advice.