A Phase II Study of the Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T Cell Lymphoma
All of the drugs used in this study are commonly used in the treatment of cancer. However,
using these drugs in combination is investigational.
During treatment, you will be given two different cycles of chemotherapy, which will be
alternated every 21 days.
For Cycle 1, cyclophosphamide will be given by vein two times a day on Days 1,2, and 3.
Each dose will take around 3 hours to give. Mesna will be given by vein nonstop over Days 1
through 3. Pegylated liposomal doxorubicin will be given by vein over 1 hour on Day 2.
Vincristine will be given by vein on Days 4 and 11. Dexamethasone will be given by mouth on
Days 1 through 4 and 11 through 14. Other drugs will be given before, during, and after
chemotherapy to help decrease the risk of developing side effects. These drugs may be given
by mouth or by injection.
For Cycle 2, methotrexate will be given by vein over 2 hours on Day 1 and over 22 hours on
day 1. Cytarabine will be given by vein twice a day on Days 2 and 3. Each dose will take
about 2 hours to give. Other drugs will be given before, during, and after treatment to
help decrease the risk of developing side effects. These drugs may be given by mouth or by
To help increase the blood counts and help decrease the risk of developing infections, your
doctor may decide that treatment with filgrastim is necessary. Filgrastim may be given as
once-a-day injections under the skin starting 24 hours after the end of Day 4 vincristine
(Cycle 1) and starting 24 hours after the end of Cytarabine (Cycle 2). Your blood counts
will be monitored and filgrastim is stopped when the levels become normal.
Cycles 1 and 2 will be alternated every 21 days. Both Cycles 1 and 2 can be given on an
outpatient basis if your physician authorizes it. However, if your serum creatinine (blood
test) reaches a certain level, Cycle 2 should be given on an inpatient basis.
Depending on how the disease responds, treatment may be stopped after 2,4, or 6 cycles.
However, treatment may continue for up to 8 cycles.
During treatment, you will have around 2-3 tablespoons of blood collected at least once a
week for routine tests.
After every 2 cycles, tumors will be measured using x-rays or other scans (CT, MRI, etc.)
and bone marrow samples will be taken. Heart scans or heart function tests may also be
needed if you doctor feels it is necessary.
If the disease gets worse or you experience any intolerable side effects, you will be taken
off the study and your doctor will discuss other treatment options with you.
After the last cycle of chemotherapy, you will have follow-up exams scheduled. During these
exams, you will have a chest x-ray and CT scans of the chest, abdomen (stomach) and pelvis
(waist area), and PET scan. You will have blood collected (2-3 tablespoons) for routine
tests. If your doctor feels it is necessary, you may also have a sample of bone marrow
collected. You may choose to have long-term follow-up exams at M. D. Anderson or with your
This is an investigational study. All of the study drugs are approved by the FDA for cancer
treatment and are commercially available. However, the use of the drugs in combination is
experimental. Up to 55 participants will take part in this study. All will be enrolled at
UT MD Anderson Cancer Center.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to Disease Progression
Baseline and response assessments every 2 cycles (cycle is 21 days)
Yasuhiro Oki, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|University of Texas MD Anderson Cancer Center||Houston, Texas 77030|