Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia

  • End date
    Jun 30, 2023
  • participants needed
  • sponsor
    M.D. Anderson Cancer Center
Updated on 23 January 2022
monoclonal antibodies
monoclonal antibody therapy


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.



I. To demonstrate the efficacy in achieving complete response of combination of cladribine administered intravenously over 2 hours for 5 days followed by rituximab weekly for 8 weeks in patients with untreated or previously treated hairy cell leukemia.

II. To examine the efficacy of rituximab to eradicate minimal residual disease (MRD) after cladribine therapy (as assessed by immunophenotyping of bone marrow and peripheral blood).

III. To examine the effect of addition of rituximab to cladribine on the long term disease-free (DFS) and overall survival (OS) (as compared with historical controls).

IV. To evaluate potential predictors of outcome including molecular and flow evaluations of MRD, as well as other potential molecular predictors such as v-raf murine sarcoma viral oncogene homolog B1 (BRAF).


Patients receive cladribine intravenously (IV) over 2 hours once daily (QD) on days 1-5 and rituximab IV once weekly for 8 weeks beginning on day 28 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year.

Condition Hairy Cell Leukemia, Recurrent Hairy Cell Leukemia
Treatment Rituximab, laboratory biomarker analysis, cladribine
Clinical Study IdentifierNCT00412594
SponsorM.D. Anderson Cancer Center
Last Modified on23 January 2022


Yes No Not Sure

Inclusion 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

Exclusion Criteria

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)
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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