Recruiting

Phase 2

Cladribine & RituximabCladribine and Rituximab in Treating Patients With Hairy Cell Leukemia

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT00412594

Conditions

Hairy Cell Leukemia

Recurrent Hairy Cell Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cladribine

Laboratory Biomarker Analysis

Rituximab

Study Details

Brief summary:

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

Study ID

NCT00412594

Start date

Jun 10, 2004

Status verified date

Jun, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (cladribine and rituximab)

Patients receive cladribine IV over 2 hours 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.

Interventions

Cladribine

Given IV

Laboratory Biomarker Analysis

Correlative studies

Rituximab

Given IV

Primary outcome measure

Efficacy of rituximab on achievement of complete response after therapy with cladribine [ Time Frame: At 12 weeks ]
Monitoring the related toxicity for the therapy Grade 3-4 [ Time Frame: Up to 1 year ]
Efficacy of rituximab in eradication of minimal residual disease after cladribine therapy, assessed by immunophenotyping of bone marrow and peripheral blood [ Time Frame: Up to 4 weeks after the last dose of rituximab ]
Efficacy of rituximab on prolongation of event-free survival [ Time Frame: Up to 1 year ]
Efficacy of rituximab on prolongation of overall survival [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

Farhad Ravandi-Kashani

713-792-7305 fravandi@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Farhad Ravandi-Kashani, MD

713-792-7305 fravandi@mdanderson.org

Principal Investigator:

Farhad Ravandi-Kashani, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-06-11.