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Phase II R-ABVD Versus ABVD for Advanced Stage Classical Hodgkin Lymphoma

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hodgkin Lymphoma

Intervention: Rituximab (Drug); Adriamycin (Drug); Bleomycin (Drug); Vinblastine (Drug); Dacarbazine (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Michelle Fanale, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

Summary

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.

Clinical Details

Official 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)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Patients with Event-Free Survival (EFS)

Detailed description: The Study Drugs: ABVD is a combination of chemotherapy drugs and is made up of doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine. The combination of drugs is designed to stop the growth of cancer cells, which may cause the cells to die. Rituximab is designed to attach to cancer cells, which may cause them to die. Study Groups: If you are eligible to take part in this study, you will be randomly assigned (like the flip of a coin) to 1 of 2 treatment "groups". If you are in Group 1, you will receive ABVD with rituximab. If you are in Group 2, you will receive ABVD. No matter which group you are assigned to, the doses of the drugs will be the standard doses that are currently used to treat lymphoma. Group 1: If you are assigned to Group 1, you will receive the ABVD combination through a needle in your vein for about 1 hour on Day 1 and 15 of every cycle (every 2 weeks). Each cycle is 4 weeks. You will also receive rituximab by vein for about 7 hours on Days 1, 8 ,15 and 22 (once a week) of Cycle 1. For Cycle 1 only, if there is not enough time for both ABVD and Rituximab to be given on Day 1, you may receive Rituximab on Day 2. For Cycle 2, you will receive rituximab on Days 1 and 8 only. You will only take rituximab for the first 2 cycles. Group 2: If you are assigned to Group 2, you will receive the ABVD combination through a needle in your vein for about 1 hour on Day 1 and 15 of every cycle (every 2 weeks). Each cycle is 4 weeks. You will not receive rituximab. Study Visits: While on study you will have tests and procedures performed at certain times and when the study doctor thinks it may be necessary. The following tests and procedures will be performed:

- On Day 1 and 15 of each cycle, blood (about 3-4 teaspoons) will be drawn for routine

tests.

- After every 4 doses of ABVD, you will also have a chest x-ray and CT scans of the neck,

chest, abdomen, and pelvis.

- If your first PET scan showed lymphoma in your body, you will have a PET scan after

every 4 doses of ABVD until the PET scan shows that there is no more lymphoma tumors in your body. Length of Study: You will remain on study for up to 6 cycles (23 weeks). You will be taken off study early if the disease gets worse, you start a new treatment for the cancer, or you experience intolerable side effects. End-of-Treatment Visit: Before you are taken off study, you will have an end-of-study visit. The following tests and procedures will be performed:

- You will have a physical exam.

- Your complete medical history will be recorded.

- Blood (about 3-4 teaspoons) will be drawn for routine tests.

- You will also have a chest x-ray and CT scans of the neck, chest, abdomen, and pelvis

to check on the size and locations of the cancer.

- If your first PET scan showed lymphoma in your body, you will have a PET scan.

Follow-up Visits: After your last study visit, you will return for follow up visits every 3 months during Year 1, every 4 months during Year 2, every 6 months during Years 3-5, and then once a year to check on the status of the disease. At these visits, the following tests and procedures will be performed:

- You will have a physical exam.

- Your complete medical history will be recorded.

- Blood (about 3-4 teaspoons) will be drawn for routine tests.

- You will also have a chest x-ray and CT scans of the neck, chest, abdomen, and pelvis

to check on the size and locations of the cancer.

- If your first PET scan showed lymphoma in your body, you will have a PET scan.

About 2 weeks after your last dose of the study drug(s), if there were lymphoma cells in your first bone marrow aspiration and biopsy, you will have a bone marrow aspiration and biopsy to check the status of the disease. This is an investigational study. The ABVD combination is FDA approved and commercially available for patients with Hodgkin's disease. Rituximab is FDA approved and commercially available. The combination of ABVD with rituximab is considered investigational. Up to 120 patients will take part in this study. Up to 70 will be enrolled at MD Anderson.

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Previously untreated patient with classical Hodgkin's lymphoma patients with stage

III and IV.

- International Prognostic Score of > 2 (patient must have > 2 of the following risk

features: Male, >/= 45 years of age, Stage IV, Albumin <4, White Blood Count (WBC) >/= 15, Lymphocytes <8% or <600, Hgb <10. 5).

- Must sign a consent form.

- Must be older than 16 years.

- Must have adequate bone marrow reserve (absolute neutrophil count (ANC) >/=

1,500/microL, Platelet > 100,000/microL).

- Left ventricular ejection fraction (LVEF) >/= 50% by Multi Gated Acquisition Scan

(MUGA) scan or echocardiogram.

- Serum creatinine < 2 mg/dl, serum bilirubin < 2 mg/dl, aspartate aminotransferase

(AST or SGOT) and alanine aminotransferase (ALT or SGPT) < 2 * ULN.

- Bi-dimensionally measurable disease.

Exclusion Criteria:

- Lymphocyte Predominant Hodgkin's Lymphoma.

- Known HIV infection.

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

contraception.

- Prior chemotherapy or radiation therapy.

- Severe pulmonary disease as judged by the PI including chronic obstructive pulmonary

disease (COPD) and asthma.

- Active infection requiring treatment with intravenous therapy.

- Presence of central nervous system (CNS) lymphoma.

- 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).

- Active hepatitis B or C infection.

Locations and Contacts

University of Miami, Coral Gables, Florida 33124, United States

Rush University, Chicago, Illinois 60612, United States

Memorial Sloan-Kettering, New York, New York 10065, United States

Cleveland Clinic, Cleveland, Ohio 44195, United States

University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States

Additional Information

University of Texas MD Anderson Cancer Center Website

Starting date: March 2008
Last updated: September 25, 2014

Page last updated: August 23, 2015

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