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Phase II Study of 2-Chlorodeoxyadenosine (2CDA) Followed By Rituximab in Hairy Cell Leukemia


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Leukemia

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Trial Information

Phase II Study of 2-Chlorodeoxyadenosine (2CDA) Followed By Rituximab in Hairy Cell Leukemia


Cladribine is a chemotherapy drug that has been used for over 10 years to treat HCL with
very good results and very low rate of side effects. Rituximab is an antibody protein that
targets a specific molecule on the surface of cancer cells in order to eliminate them. It
has been used for over 5 years to treat a number of cancers of blood and lymph nodes and has
been used with some success to treat patients with HCL whose disease has returned after a
previous remission.

If you are found to be eligible to take part in this study, you will receive cladribine by
vein over 2 hours once a day for 5 days in a row. You will only receive 1 cycle (5 days) of
this treatment. Then you will receive rituximab by vein once a week for 8 weeks. Treatment
with rituximab will start around Day 28.

After the first dose of each study drug has been given to you at MD Anderson, all later
doses of both drugs can be given to you by your community doctor in your home town. You
will have a weekly blood tests (about 1 teaspoon each) for the first 4 weeks and before
receiving rituximab. You will have a repeat bone marrow biopsy before starting rituximab in
order to see how much disease is left behind. You will then have a blood test (about 1
teaspoon) every 2 to 4 weeks while you are receiving rituximab. A bone marrow biopsy will
also be done at the end of rituximab treatment.

You will be taken off the study if the disease gets worse or if intolerable side effects
occur. After completing rituximab, you will return for a follow-up visit every 3 months for
one year. At these visits you will have blood (about 1 teaspoon) tests performed.

This is an investigational study. Both drugs are approved by the FDA and are commercially
available. Their use together in this study, however, is experimental. A total of 74
patients will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. Age 18 years and older

2. Diagnosis of HCL established by bone marrow examination

3. Patients with relapsed disease are eligible if they have had no more than one prior
therapy

4. Women of child-bearing potential must use birth control (oral contraceptive, barrier,
abstinence or any other acceptable method) for the duration of the study

5. Performance status
6. Adequate renal function: creatinine less than or equal to 2.0 unless related to the
disease

7. Adequate liver function: bilirubin less than or equal to 3.0, transaminases less than
or equal 3 * upper limit of normal unless related to the disease

8. No prior investigational agent in the 4 weeks prior to initiation of therapy

Exclusion Criteria:

1. Unable or unwilling to sign the consent form

2. Known infection with HIV, hepatitis B or C

3. Presence of active infection

4. Presence of Central Nervous System (CNS) metastases

5. New York Heart Association Classification III or IV heart disease

6. Prior chemotherapy (last 4 weeks)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete Response

Outcome Time Frame:

12 weeks

Safety Issue:

Yes

Principal Investigator

Farhad Ravandi-Kashani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2004-0223

NCT ID:

NCT00412594

Start Date:

September 2004

Completion Date:

Related Keywords:

  • Leukemia
  • Hairy Cell Leukemia
  • Leukemia
  • 2CDA
  • 2-chlorodeoxyadenosine
  • Rituximab
  • Rituxan
  • HCL
  • Leukemia
  • Leukemia, Hairy Cell

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030