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

Who is this study for? Patients with Hairy Cell Leukemia
What treatments are being studied? Cladribine+Laboratory Biomarker Analysis+Rituximab
Status: Recruiting
Location: See location...
Intervention Type: Biological, Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This phase II trial studies the side effects and how well cladribine and rituximab work in treating patients with hairy cell leukemia. Drugs used in chemotherapy, such as cladribine, work in different ways to stop the growth of cancer cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cladribine together with rituximab may kill more cancer cells.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 years and older

• Diagnosis of hairy cell leukemia (HCL) established by bone marrow examination

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

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

• Performance status =\< 3

• Creatinine less than or equal to 2.0 unless related to the disease

• Bilirubin less than or equal to 3.0

• Transaminases less than or equal 3 x upper limit of normal unless related to the disease

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

Locations
United States
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Farhad Ravandi-Kashani
fravandi@mdanderson.org
713-792-7305
Time Frame
Start Date: 2004-06-10
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 150
Treatments
Experimental: Treatment (cladribine and rituximab)
Patients receive cladribine IV over 2 hours QD on days 1-5 and rituximab IV once weekly for 8 weeks beginning on day 28 in the absence of disease progression or unacceptable toxicity.
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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