MDACC Study Summary ID00-218

Study Summary
No. ID00-218:.......Lymphoma......Anas Younes......Lymphoma/Myeloma

Study Summary Title



Study Summary Number:	ID00-218

Study Title:	A Phase II Study of Rituximab + ABVD for Patients with Hodgkin's Disease

Physician

New Patient Referral



Name:	Anas Younes	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Lymphoma/Myeloma	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2860 Contact us about clinical trials

General Information



Disease Group:	Lymphoma	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Every 2 weeks.

Treatment Agents:	Adriamycin Bleomycin DTIC Rituximab Vinblastine Sulfate	Home Care:	None

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to find out if ABVD chemotherapy (sometimes with radiation therapy to areas of large lymph nodes) given with rituximab can improve the cure rate of patients with Hodgkin's disease. The safety of this new combination therapy will also be studied.

Study Objectives / Outcomes

To determine the feasibility, toxicity, and efficacy of Rituximab with standard dose ABVD
combination chemotherapy.

Study Status Information



Study Activation / Registration Date:	03/09/2001

IRB Review and Approval Date:	08/02/2000

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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) LVEF >/= 50% by 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 COPD and asthma.

Links

Registration Number: NCT00504504
Study Information on Clinical Trials Registry (clinicaltrials.gov)