MDACC Study Summary 2007-0144

Study Summary
No. 2007-0144:.......Lymphoma......Anas Younes......Lymphoma/Myeloma

Study Summary Title



Study Summary Number:	2007-0144

Study Title:	A RANDOMIZED PHASE II STUDY OF RITUXIMAB WITH ABVD VERSUS STANDARD ABVD FOR PATIENTS WITH ADVANCED-STAGE CLASSICAL HODGKIN LYMPHOMA WITH POOR RISK FEATURES (IPS SCORE > 2)

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:	Genentech

Phase of Study:	Phase II	Return Visit:	Every 2 weeks for chemotherapy for 6 months. After treatment ends, patients will return for follow-up every 3 months for 1st year, every 4 months for 2nd year, every 6 months for Years 3-5, and annually thereafter.

Treatment Agents:	Adriamycin Bleomycin Dacarbazine Rituximab Vincristine	Home Care:	N/A

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to compare the effectiveness of receiving Adriamycin (doxorubicin hydrochloride), bleomycin, vinblastine, and dacarbazine (ABVD) therapy alone to receiving ABVD with rituximab.

Study Objectives / Outcomes

Primary:

To evaluate the event free survival (EFS) following therapy with rituximab plus ABVD or standard ABVD in patients with newly diagnosed classical Hodgkin lymphoma who have poor prognosis defined as International prognostic score (IPS) of > 2.

Secondary:

1. To compare the effect of the two treatment arms on PET scan results after 2 cycles of therapy.

2. To compare the effect of the two treatment arms on the level of circulating malignant Hodgkin stem cells.

Study Status Information



Study Activation / Registration Date:	03/19/2008

IRB Review and Approval Date:	11/13/2007

Study Type:	Phase Iii

Recruitment Status:	Open

Projected Accrual:	120

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) Previously untreated patient with classical Hodgkin's lymphoma patients with stage III and IV.

2) International Prognostic Score of > 2 (patient must have > 2 of the following risk features: Male, >/= 45 years of age, Stage IV, Albumin <4, WBC >/= 15, Lymphocytes <8% or <600, Hgb <10.5).

3) Must sign a consent form.

4) Must be older than 16 years.

5) Must have adequate bone marrow reserve (ANC >/= 1,500/microL, Platelet > 100,000/microL).

6) LVEF >/= 50% by MUGA scan or echocardiogram.

7) Serum creatinine < 2 mg/dl, serum bilirubin < 2 mg/dl, AST or ALT < 2 x ULN.

8) Bi-dimensionally measurable disease.

Exclusion Criteria:

1) Lymphocyte Predominant Hodgkin's Lymphoma.

2) Known HIV infection.

3) Pregnant women and women of child bearing age who are not practicing adequate contraception.

4) Prior chemotherapy or radiation therapy.

5) Severe pulmonary disease as judged by the PI including COPD and asthma.

6) Active infection requiring treatment with intravenous therapy.

7) Presence of CNS lymphoma.

8) Concomitant malignancies or previous malignancies within the last 5 years (exception made for adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of cervix).

9) Active hepatitis B or C infection.

Links

Registration Number: NCT00654732
Study Information on Clinical Trials Registry (clinicaltrials.gov)