Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia

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.

Conditions

Hairy Cell Leukemia, Recurrent Hairy Cell Leukemia

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Study Overview

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Study Details

Study overview

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.

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

Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia

Condition
Hairy Cell Leukemia
Intervention / Treatment

-

Contacts and Locations

Houston

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * Unable or unwilling to sign the consent form
  • * Known infection with human immunodeficiency virus (HIV), hepatitis B or C
  • * Presence of active infection
  • * Presence of central nervous system (CNS) metastases
  • * New York Heart Association classification III or IV heart disease
  • * Prior chemotherapy (last 4 weeks)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

M.D. Anderson Cancer Center,

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

Study Record Dates

2025-06-30