Phase 2
N=82
Rituximab and ABVD for Hodgkin's Patients
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00504504 ↗Enrolled (actual)
82
Serious AEs
48.8%
Results posted
Jul 2013
Primary outcome: Primary: 5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD — 83 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rituximab (Drug); Adriamycin (Drug); Bleomycin (Drug); Vinblastine (Drug); Dacarbazine (DTIC) (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD |
83 | — |
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.
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.
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.