2CDA With Rituximab in Hairy Cell Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00412594
Recruitment Status : Recruiting
First Posted : December 18, 2006
Last Update Posted : December 12, 2018
Genentech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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.

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 150 patients will take part in this study. All will be enrolled at MD Anderson.

Condition or disease Intervention/treatment Phase
Leukemia Drug: Cladribine Drug: Rituximab Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of 2-Chlorodeoxyadenosine (2CDA) Followed By Rituximab in Hairy Cell Leukemia
Actual Study Start Date : June 10, 2004
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
Experimental: 2CDA + Rituximab
Cladribine (2CDA) 5.6 mg/m^2 by vein over 2 hours daily for 5 days; Rituximab 375 mg/m^2 by vein weekly times 8 starting on day 28 (plus or minus 4 days) following 2CDA treatment.
Drug: Cladribine
5.6 mg/m^2 by vein over 2 hours daily for 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

Primary Outcome Measures :
  1. Complete Response [ Time Frame: 12 weeks ]
    Complete response (CR) defined as absence of hairy cells in the bone marrow (BM) or presence of less than 1% atypical cells (not definitively called hairy cells) and disappearance of all evidence of HCL on physical examination. Hematologic parameters for CR require an ANC of 1.5 x 109/L or greater; Hgb at least 12.0 g/dL (at least 11.0 g/dL for females); and PLT at least 100 x 109/L without growth factor or transfusion support. CR with residual disease (CR-RD) is defined as for CR but with persistence of 1% to 5% hairy cells in the marrow (but no circulating hairy cells).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 </= 3
  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 x 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 CNS metastases
  5. New York Heart Association Classification III or IV heart disease (See Appendix I)
  6. Prior chemotherapy (last 4 weeks)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00412594

Contact: Farhad Ravandi-Kashani, MD 713-792-7305

United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genentech, Inc.
Principal Investigator: Farhad Ravandi-Kashani, MD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00412594     History of Changes
Other Study ID Numbers: 2004-0223
NCI-2012-01394 ( Registry Identifier: NCI CTRP )
First Posted: December 18, 2006    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Hairy Cell Leukemia

Additional relevant MeSH terms:
Leukemia, Hairy Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Immunosuppressive Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action