2CDA With Rituximab in Hairy Cell Leukemia - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Genentech
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00412594

Purpose

The goal of this clinical research study is to learn if treatment with 2CDA (cladribine) followed by treatment with rituximab can help to control HCL. The safety of this combination treatment will also be studied.

Condition	Intervention	Phase
Leukemia	Drug: Cladribine Drug: Rituximab	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Study of 2-Chlorodeoxyadenosine (2CDA) Followed By Rituximab in Hairy Cell Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia

Drug Information available for: Cladribine Rituximab

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Complete Response [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	74
Study Start Date:	September 2008
Estimated Primary Completion Date:	September 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 2CDA + Rituximab 2CDA = Cladribine	Drug: Cladribine 5.6 mg/m^2 by vein over 2 hours daily x 5 days Other Names: Leustatin 2-Cda Drug: Rituximab 375 mg/m^2 by vein weekly x 8 starting on day 28 (plus or minus 4 days) following 2CDA treatment. Other Name: Rituxan

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18 years and older
Diagnosis of 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
Adequate renal function: creatinine less than or equal to 2.0 unless related to the disease
Adequate liver function: 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

Exclusion Criteria:

Unable or unwilling to sign the consent form
Known infection with HIV, hepatitis B or C
Presence of active infection
Presence of CNS metastases
New York Heart Association Classification III or IV heart disease (See Appendix I)
Prior chemotherapy (last 4 weeks)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412594

Contacts

Contact: Farhad Ravandi-Kashani, MD

713-792-7305

Locations

United States, Texas
UT MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Farhad Ravandi-Kashani, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Genentech

Investigators

Principal Investigator:

Farhad Ravandi-Kashani, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided by M.D. Anderson Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ravandi F, O'Brien S, Jorgensen J, Pierce S, Faderl S, Ferrajoli A, Koller C, Challagundla P, York S, Brandt M, Luthra R, Burger J, Thomas D, Keating M, Kantarjian H. Phase 2 study of cladribine followed by rituximab in patients with hairy cell leukemia. Blood. 2011 Oct 6;118(14):3818-23. Epub 2011 Aug 5.

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00412594 History of Changes
Other Study ID Numbers:	2004-0223
Study First Received:	December 14, 2006
Last Updated:	May 17, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Hairy Cell Leukemia
Leukemia
2CDA
2-chlorodeoxyadenosine

Rituximab
Rituxan
HCL

Additional relevant MeSH terms:

Leukemia
Leukemia, Hairy Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
2-chloro-3'-deoxyadenosine
Rituximab
Cladribine

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 22, 2012