Phase 2 N=50 Treatment

Phase 2 Study of Rituximab-ABVD in Classical Hodgkin Lymphoma

Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT00369681 ↗

Enrolled (actual)

Serious AEs

32.0%

Results posted

Jul 2015

Primary outcome: Primary: Effect of Rituximab on EBV(+) Tumors — 0 relapses

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Bleomycin (Drug); Rituximab (Biological); Dacarbazine (Drug); Doxorubicin (Drug); Vinblastine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Primary completion: Oct 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Effect of Rituximab on EBV(+) Tumors	—	—
PRIMARY Relationship Between Marker Detection and Clinical Outcome	0; 2	—
SECONDARY Event-free Survival	83	—
SECONDARY Addition of Information to Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) by Plasma DNA Biomarkers	—	—

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 patients with newly diagnosed stage II, stage III, or stage IV Hodgkin's lymphoma.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed classical Hodgkin's lymphoma
No lymphocyte-predominant histology
Stage II, III, or IV disease
Newly diagnosed disease

PATIENT CHARACTERISTICS:

Performance status 0-2
Creatinine < 2.0 mg/dL
Bilirubin < 5 mg/dL
Not pregnant or nursing
No HIV positivity
Hepatitis B surface antigen negative
No active concurrent malignancy except for superficial nonmelanoma skin cancer or cervical carcinoma in situ

PRIOR CONCURRENT THERAPY:

No prior chemotherapy or radiotherapy for Hodgkin's lymphoma
Steroids allowed if medically required before chemotherapy initiation

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00369681). 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.