Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT00412594

Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia

Led by M.D. Anderson Cancer Center · Updated on 2025-12-22

150

Participants Needed

1

Research Sites

1202 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years and older
  • Diagnosis of hairy cell leukemia established by bone marrow examination
  • Patients with relapsed disease allowed if they have had no more than one prior therapy
  • Women of child-bearing potential must use birth control during the study
  • Performance status of 3 or less
  • Creatinine level less than or equal to 2.0 unless related to the disease
  • Bilirubin level less than or equal to 3.0
  • Transaminases less than or equal to 3 times the upper limit of normal unless related to the disease
  • No prior investigational agent use within 4 weeks before starting therapy
Not Eligible

You will not qualify if you...

  • Unable or unwilling to sign the consent form
  • Known infection with HIV, hepatitis B, or hepatitis C
  • Presence of active infection
  • Presence of central nervous system metastases
  • New York Heart Association class III or IV heart disease
  • Prior chemotherapy within the last 4 weeks

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

F

Farhad Ravandi-Kashani

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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