Clinical trial NCT00412594: Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
Official title: Phase II Study of 2-Chlorodeoxyadenosine (2CDA) Followed by Rituximab in Hairy Cell Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hairy Cell Leukemia
Recurrent Hairy Cell Leukemia
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-12-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Efficacy of rituximab on achievement of complete response after therapy with cladribine
timeFrame: At 12 weeks
measure: Monitoring the related toxicity for the therapy Grade 3-4
timeFrame: Up to 1 year
measure: Efficacy of rituximab in eradication of minimal residual disease after cladribine therapy, assessed by immunophenotyping of bone marrow and peripheral blood
timeFrame: Up to 4 weeks after the last dose of rituximab
measure: Efficacy of rituximab on prolongation of event-free survival
timeFrame: Up to 1 year
measure: Efficacy of rituximab on prolongation of overall survival
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Farhad Ravandi-Kashani
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ravandi F, O'Brien S, Jorgensen J, Pierce S, Faderl S, Ferrajoli A, Koller C, Challagundla P, York S, Brandt M, Luthra R, Burger J, Thomas D, Keating M, Kantarjian H. Phase 2 study of cladribine followed by rituximab in patients with hairy cell leukemia. Blood. 2011 Oct 6;118(14):3818-23. doi: 10.1182/blood-2011-04-351502. Epub 2011 Aug 5.