Rituximab and ABVD for Hodgkin's Patients

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00504504
• Other study ID #: ID00-218
• Status: Completed
• Phase: Phase 2
• First received: July 19, 2007
• Last updated: May 20, 2013
• Start date: March 2001
• Est. completion date: March 2012

Study information

• Verified date: May 2013
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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 necessary.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 contraception.

3. Prior chemotherapy.

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

Study Design

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

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• Rituximab
375 mg/m^2 by vein over 3 to 8 hours weekly for 6 weeks in a row.
• Adriamycin
25 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
• Bleomycin
10 U/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
• Vinblastine
6 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
• Dacarbazine (DTIC)
375 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.

Locations

Country	Name	City	State
United States	UT MD . Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Younes A, Oki Y, McLaughlin P, Copeland AR, Goy A, Pro B, Feng L, Yuan Y, Chuang HH, Macapinlac HA, Hagemeister F, Romaguera J, Samaniego F, Fanale MA, Dabaja BS, Rodriguez MA, Dang N, Kwak LW, Neelapu SS, Fayad LE. Phase 2 study of rituximab plus ABVD in — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD	Five year Event Free Survival (EFS) is proportion of surviving participants who remain event free out of total participants at 5 years after receiving Rituximab + ABVD (RABVD). Event-free Survival (EFS) analyzed every 6 months.	Baseline to 5 Years or until disease progression	No

External Links

•   UT MD Anderson Cancer Center website