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Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Chimeric Anti-CD20 Monoclonal Antibody (Rituximab) for Stage IV Indolent Lymphoma


Phase 3
N/A
76 Years
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Chimeric Anti-CD20 Monoclonal Antibody (Rituximab) for Stage IV Indolent Lymphoma


Rituximab is a monoclonal antibody that is designed to attach to leukemia cells and activate
a series of events that may cause the cancer cells to die.

Fludarabine is designed to make cancer cells less able to repair damaged DNA (the genetic
material of cells). This may increase the likelihood of the cells dying.

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

Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body.
Dexamethasone is often given to MM patients in combination with other chemotherapy to treat
cancer.

Study Groups:

If you are found eligible to take part in this study, you will be randomly assigned (as in
the flip of a coin) to 1 of 2 study groups. Each group will receive 8 "cycles" of
treatment. One (1) cycle will last 28 days.

Group 1:

If you are in Group 1, you will receive the following drugs at the following times. Each
study cycle is 28 days:

- Rituximab will be given through a needle in the vein over about 90 minutes on Days 1
and 8 of the first course Cycle 1, and on Day 1 only of Cycles 2-5 of Fludarabine/
Mitoxantrone/ Dexamethasone (FND) treatment.

- Fludarabine will be given through a needle in the vein over about 15 minutes on Days
2-4 of each cycle.

- Mitoxantrone will be given through a needle in the vein over about 15 minutes on Day 2
of each cycle.

- You will take dexamethasone by mouth with water on Days 1-5 of each 28-day cycle (FND).

If you miss any doses of the study drugs, please contact the research staff for
instructions.

You will not receive rituximab in Cycles 6-8. When the 8 cycles are finished, you will
begin receiving the drug interferon on Days 1-14 each month for 1 year. Dexamethasone will
be given on Days 1-3 every month for 1 year.

Patients in group 2 will receive fludarabine on Days 1-3, mitoxantrone on Day 1, and
dexamethasone on Days 1-5 of each 28-day cycle. When 8 cycles of treatment are finished,
patients will begin receiving the drug interferon on Days 1-14 each month for 1 year.
Dexamethasone will be given on Days 1-3 every month for 1 year. About 4 months after
interferon treatment starts, patients in group 2 will begin receiving rituximab once a month
for 6 months.

Other drugs may be given to help decrease the risk of or ease side effects. Treatment may
be delayed or stopped if side effects are severe.

Most of the drugs are given by vein. A catheter (a tube) will be placed in a vein to
decrease the number of needle sticks. Dexamethasone may be taken by mouth instead of given
by vein.

Some patients in this study, with changes in certain genes will receive different
chemotherapy drugs than other patients in the study will. The patients will, like all the
other patients, receive rituximab and interferon. But instead of the FND chemotherapy
regimen, they will receive a sequence of three regimens, CHOD-Bleo, ESHAP, and NOPP. The
drugs in these regimens include: cyclophosphamide, doxorubicin, vincristine, bleomycin,
VP-16, Ara-C, cisplatin, mitoxantrone, procarbazine, and corticosteroids (prednisone,
methylprednisolone, dexamethasone).

During the study, patients will have blood tests every week. Complete exams will be given
in Cycles 2 and 4; patients will return to the clinic for these. Every 2 or 3 cycles,
patients will have a chest x-ray and CT scans of the abdomen and pelvis. Bone marrow
samples will be taken. Heart function tests (EKG) will be done as needed.

After the study ends, patients will return for checkups every 3 months in the first year,
every 4 months in years 2 and 3, and every 6 months in years 4 and 5. After that, checkups
will be needed once a year. Blood and bone marrow samples will be taken at these visits.

This is an investigational study. Rituximab is approved by FDA for commercial use. The
other drugs used in the study are also approved for commercial use. About 210 patients will
take part in the study. All will be enrolled at UTMDACC.


Inclusion Criteria:



1. Previously untreated stage IV indolent B-cell lymphoma [Amendment May 2001:
eligibility restricted to follicular lymphoma]

2. Age <76

Exclusion Criteria:

N/A

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To study and compare molecular response rates with the FND regimen followed by rituximab (chimeric anti-CD20 antibody) and interferon versus FND plus rituximab concurrently, followed by interferon

Outcome Time Frame:

10 Years

Safety Issue:

No

Principal Investigator

Nathan Fowler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

DM97-261

NCT ID:

NCT00577993

Start Date:

March 1998

Completion Date:

December 2014

Related Keywords:

  • Lymphoma
  • Lymphoma
  • Follicular Lymphoma
  • Indolent Lymphoma
  • Fludarabine
  • Novantrone
  • Mitoxantrone
  • Decadron
  • Dexamethasone
  • Rituximab
  • Anti-CD20
  • IDEC-C2B8
  • Chimeric Anti-CD20 Antibody
  • Interferon
  • Interferon Alpha-2b
  • IFN
  • Doxorubicin
  • Vincristine
  • Bleomycin
  • Cyclophosphamide
  • Etoposide
  • Cisplatin
  • Ara-C
  • Methyl-Prednisolone
  • Procarbazine
  • Prednisone
  • FND
  • Lymphoma

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030