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A Phase II Study of Rituximab + ABVD for Patients With Hodgkin's Disease

Phase 2
16 Years
Not Enrolling

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Trial Information

A Phase II Study of Rituximab + ABVD for Patients With Hodgkin's Disease

Before treatment starts, patients will have a physical exam. Bone marrow samples will be
taken. Blood samples (4 to 8 tablespoons) will be taken before and during the study. A
chest x-ray, CT scans of the abdomen and pelvis, and a gallium scan will be done if

Patients in this study will receive rituximab by vein over 3 to 8 hours weekly for 6 weeks
in a row. ABVD will be injected over 3 hours every other week for a total of 12 treatments.
On the cycles where both rituximab and ABVD are given, rituximab will be given on day 1,
and ABVD will be given on day 2. Response to therapy will be determined after 3 months and
at the end of therapy (6 months). At the end, patients may receive radiation therapy to
areas of large masses. All treatments can be given in an outpatient setting.

Scans and x-rays will be repeated if needed after completion of therapy and every 3 months
from then on. If tumors do not shrink after 3 months of therapy, patients will be offered a
different treatment.

This is an investigational study. Although ABVD is considered the standard treatment for
patients with Hodgkin's disease, the combination of ABVD with rituximab is considered
investigational. All drugs involved in this study are commercially available and are
approved by the FDA. Up to 85 patients will take part in this study. All will be enrolled
at M. D. Anderson. This protocol is partially funded by a research grant from Genentech.

Inclusion Criteria:

1. 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.

2. Must have histologically proven diagnosis of Hodgkin's disease (Nodular sclerosis or
mixed cellularity).

3. Must have bidimensionally measurable disease.

4. Must sign a consent form.

5. Must be older than 16 years of age.

6. Must have adequate bone marrow reserve (ANC > 1,000/microL, Platelet > 100,000/microL

7. Left Ventricular Ejection Fraction (LVEF) >/= 50% by multigated acquisition (MUGA)
scan or echocardiogram.

8. Serum creatinine < 2 mg/dl, serum bilirubin < 2 mg/dl

Exclusion Criteria:

1. HIV positive.

2. Pregnant women and women of child bearing age who are not practicing adequate

3. Prior chemotherapy.

4. Severe pulmonary disease including Chronic obstructive pulmonary disease (COPD) and

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

5-year failure-free survival rate for patients with Hodgkin's disease given Rituximab with ABVD

Outcome Description:

Event free survival (EFS) using Rituximab+ABVD (RABVD) in newly diagnosed patients with advanced stage classical Hodgkin lymphoma (HL). Event-free Survival (EFS) analyzed every 6 months.

Outcome Time Frame:

Baseline to 5 Years or until disease progression

Safety Issue:


Principal Investigator

Anas Younes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

March 2001

Completion Date:

March 2012

Related Keywords:

  • Lymphoma
  • Hodgkin's Disease
  • Lymphoma
  • Rituximab
  • Rituxan
  • Adriamycin
  • Doxorubicin
  • Rubex
  • Bleomycin
  • Bleomycin sulfate
  • Blenoxane
  • BLM
  • Dacarbazine
  • DTIC
  • DTIC-Dome
  • Vincristine
  • Vinblastine
  • Vinblastine Sulfate
  • ABVD
  • ABVD Chemotherapy Treatment
  • Hodgkin Disease
  • Lymphoma



UT MD . Anderson Cancer Center Houston, Texas  77030