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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)


Phase 2
16 Years
N/A
Open (Enrolling)
Both
Hodgkin Lymphoma

Thank you

Trial Information

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)


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 Computed tomography
(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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Patients with Event-Free Survival (EFS)

Outcome Description:

Efficacy of combination regimen of rituximab and ABVD chemotherapy (R-ABVD) and ABVD alone measured as event-free survival (EFS).

Outcome Time Frame:

Baseline to 3 Years

Safety Issue:

No

Principal Investigator

Michelle Fanale, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

U.T MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2007-0144

NCT ID:

NCT00654732

Start Date:

March 2008

Completion Date:

Related Keywords:

  • Hodgkin Lymphoma
  • Hodgkin Lymphoma
  • Lymphoma
  • Adriamycin
  • Doxorubicin Hydrochloride
  • Adriamycin PFS®
  • Adriamycin RDF™
  • Rituxan
  • Rituximab
  • Bleomycin
  • Bleomycin sulfate
  • Blenoxane®
  • BLM
  • Vinblastine
  • Velban
  • Dacarbazine
  • DTIC
  • DTIC-Dome®
  • R-ABVD
  • ABVD
  • Hodgkin Disease
  • Lymphoma

Name

Location

Cleveland ClinicCleveland, Ohio  44195
UT MD Anderson Cancer CenterHouston, Texas  77030
Memorial Sloan-KetteringNew York, New York  
University of MiamiMiami, Florida  33136
Rush UniversityChicago, Illinois  60612