RECRUITING

Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2004-06-10
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT00412594

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years and older
  2. * Diagnosis of hairy cell leukemia (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. * Creatinine less than or equal to 2.0 unless related to the disease
  7. * Bilirubin less than or equal to 3.0
  8. * Transaminases less than or equal 3 x upper limit of normal unless related to the disease
  9. * No prior investigational agent in the 4 weeks prior to initiation of therapy
  1. * Unable or unwilling to sign the consent form
  2. * Known infection with human immunodeficiency virus (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)

Contacts and Locations

Study Contact

Farhad Ravandi-Kashani
CONTACT
713-792-7305
fravandi@mdanderson.org

Principal Investigator

Farhad Ravandi-Kashani
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Farhad Ravandi-Kashani, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2004-06-10
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2004-06-10
Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Hairy Cell Leukemia
  • Recurrent Hairy Cell Leukemia