Clinical trial NCT00901927
Conditions: Follicular Lymphoma
Keywords: Lymphoma Non-Hodgkin's Lymphoma Untreated High Risk Follicular Lymphoma Bendamustine hydrochloride Bendamustine HCI Bendamustine CEP-18083 SDX-105 Treanda Mitoxantrone Novantrone Rituximab Rituxan
Sponsor: M.D. Anderson Cancer Center
Start date: 2009-05-01; Completion date: 2016-01-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn if the combination of bendamustine hydrochloride, mitoxantrone, and rituximab can help to control follicular lymphoma.

The safety of this drug combination will also be studied.

Detailed description:
The Study Drugs:

Bendamustine is designed to damage and destroy the DNA (genetic material) of cancer cells.

Mitoxantrone is designed to stop cancer cells from making DNA, which may stop the cells from making more cells.

Rituximab is designed to attach to lymphoma cells, which may cause them to die.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive the study drugs in 28-day "cycles."

On Days 1 and 2 of each cycle, you will receive bendamustine through a needle in a vein over 30-60 minutes.

On Day 1 of each cycle, you will receive rituximab by vein over several hours, depending on how well you tolerate it. Usually, the first dose of rituximab is given over 6-8 hours. If you tolerate the first dose well, you will receive the next doses over 4 hours.

On Day 2 of each cycle, you will receive mitoxantrone by vein over 15 minutes.

Study Visits:

At every study visit (Days 1, 8, 15, and 22 of each cycle), your vital signs will be measured. You will be asked if you have experienced any side effects and to list any drugs you may be taking. The measurement of vital signs on Days 8, 15, and 22 of each cycle may be done by your personal doctor, and the results can be sent in to the study staff.

On Day 1 of each cycle, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your weight.
* Blood (about 1-2 teaspoons) will be drawn for routine tests.
* You will have a performance status evaluation.

On Days 8, 15, and 22 of each cycles, blood (about 1 teaspoon) will be drawn for routine tests. These tests may be performed by your personal doctor, and the results can be sent in to the study staff.

At the end of Cycle 3, you will have a positron emission tomography (PET) scan and/or CT scan to check the status of the disease.

If your bone marrow showed lymphoma at the beginning of the study, you will have an additional bone marrow aspiration and biopsy if the disease goes away while you are on study. This will be to check the status of the disease.

If at any time the doctor thinks it is necessary, you will have extra blood and urine collected for routine tests.

Length of Study Participation:

You may receive up to 6 cycles (about 6 months) of study treatment. If the disease gets worse or intolerable side effects occur, you will be taken off study treatment early.

End-of-Study Visit:

At 30-40 days after your last dose of study drugs, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs and weight.
* You will have a performance status evaluation.
* Blood (about 1-2 teaspoons) will be drawn for routine tests.
* You will have CT and PET scans to check the status of the disease.
* You will be asked if you have experienced any side effects and to list any drugs you may be taking.

Long-Term Follow-Up:

Every 3 months for 2 years after your study treatment ends, you will have follow-up visits. If after 2 years your body shows no signs of cancer, you will have follow-up visits every 6 months after that. These follow-up tests are considered routine care.

The following tests and procedures will be performed at these visits:

* You will have a performance status evaluation.
* Blood (about 1-2 teaspoons) will be drawn for routine tests.
* You will be asked how you are doing and whether you are receiving any new treatments for the disease.
* You will have CT and PET scans to check the status of the disease.
* The study doctor will check the results of any other scans and tests you may have for routine care. The study doctor will also check the results of physical exams you may have.

This is an investigational study. All 3 study drugs are commercially available. Rituximab is FDA approved to treat follicular lymphoma. Mitoxantrone is FDA approved for use in combination for certain types of leukemia. Bendamustine is FDA approved to treat chronic lymphocytic leukemia.

The combination of rituximab, mitoxantrone, and bendamustine is not FDA approved to treat follicular lymphoma. At this time, it is only being used in research.

Up to 37 patients will take part in this study. All will be enrolled at M. D. Anderson.

Arms: arm 1: Bendamustine starting dose 90 mg/m\^2 intravenously (IV) over 30-60 minutes on Days 1 and 2 of each 8-day cycle. Mitoxantrone 10 mg/m\^2 IV over 15 minutes on Day 2 of each cycle. Rituximab 375 mg/m\^2 IV over several hours on Day 1 of each cycle.
Interventions: intervention 1: Bendamustine intervention 2: Mitoxantrone intervention 3: Rituximab
Intervention descriptions: intervention 1: Starting dose 90 mg/m\^2 by vein over 30-60 minutes on Days 1 and 2 of each cycle. intervention 2: 10 mg/m\^2 by vein over 15 minutes on Day 2 of each cycle. intervention 3: 375 mg/m\^2 by vein over several hours on Day 1 of each cycle.

Protocol documents: