Phase 2
Completed N=30
Study of a-Interferon With Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD) With Hodgkin's Disease
Source: ClinicalTrials.gov NCT01404936 ↗Enrolled (actual)
30
Serious AEs
10.0%
Results posted
Feb 2013
Primary outcomePrimary: Participants' Response — 23; 2; 3; 1 participants
Summary
This is a clinical research study of interferon (IFN) plus chemotherapy with the standard combination of Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD). The treatment will be given to patients with Hodgkin's disease. The study will look at whether adding IFN to ABVD improves the immune response against Hodgkin's disease, and will determine whether the toxicity of ABVD is increased by adding IFN.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants' Response |
23; 2; 3; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Hodgkin's disease patients who relapse after radiation therapy alone, or in combination with Novantrone, Oncovin, Velban, and Prednisone (NOVP); and previously untreated patients with stage III and IV who are eligible for standard ABVD therapy.
- Must have adequate bone marrow reserve Absolute neutrophil count (ANC) > 1,000/uL, Platelets > 100,000
- Left ventricular ejection fraction (LVEF) >/= 50%, serum creatinine < 2mg/dl, serum bilirubin < 2mg/dl
Exclusion Criteria
- No prior therapy with Mustargen Oncovin Procarbazine Prednisone (MOPP).
- No severe pulmonary disease including Chronic obstructive pulmonary disease (COPD) and asthma.
Data sourced from ClinicalTrials.gov (NCT01404936). 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.