Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia

Hairy Cell Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00412594
• Other study ID #: 2004-0223
• Secondary ID: NCI-2012-0139420
• Status: Recruiting
• Phase: Phase 2
• Start date: June 10, 2004
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: Farhad Ravandi-Kashani
• Phone: 713-792-7305
• Email: fravandi[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

PRIMARY OBJECTIVES:

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).

OUTLINE:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hairy Cell Leukemia
• Leukemia
• Leukemia, Hairy Cell
• Recurrent Hairy Cell Leukemia

Intervention

Drug:
• Cladribine
Given IV

Other:
• Laboratory Biomarker Analysis
Correlative studies

Biological:
• Rituximab
Given IV

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of rituximab on achievement of complete response after therapy with cladribine	Defined as the absence of hairy cells in the bone marrow or the presence of less than 1 percent atypical cells and the disappearance of all evidence of hairy cell leukemia on physical examination. Monitored using the method of Thall, Simon, Estey as extended by Thall and Sung.	At 12 weeks
Primary	Monitoring the related toxicity for the therapy Grade 3-4	Monitored using the method of Thall, Simon, Estey as extended by Thall and Sung.	Up to 1 year
Primary	Efficacy of rituximab in eradication of minimal residual disease after cladribine therapy, assessed by immunophenotyping of bone marrow and peripheral blood	The method of Thall, Simon, Estey as extended by Thall and Sung will be used for efficacy and safety monitoring.	Up to 4 weeks after the last dose of rituximab
Primary	Efficacy of rituximab on prolongation of event-free survival		Up to 1 year
Primary	Efficacy of rituximab on prolongation of overall survival		Up to 1 year

External Links

•   MD Anderson Cancer Center Website