2CDA With Rituximab in Hairy Cell Leukemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00412594
First received: December 14, 2006
Last updated: September 16, 2014
Last verified: September 2014
  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:


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

Primary Outcome Measures:
  • Complete Response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 150
Study Start Date: September 2004
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 150 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:

  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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Locations
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
Investigators
Principal Investigator: Farhad Ravandi-Kashani, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided by M.D. Anderson Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00412594     History of Changes
Other Study ID Numbers: 2004-0223, NCI-2012-01394
Study First Received: December 14, 2006
Last Updated: September 16, 2014
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
Rituximab
2-chloro-3'-deoxyadenosine
Cladribine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Immunosuppressive Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014