Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Cladribine
  Given IV
• Другое Laboratory Biomarker Analysis
  Correlative studies
• Биопрепарат Rituximab
  Given IV

Первичные конечные точки

• Efficacy of rituximab on achievement of complete response after therapy with cladribine [Срок оценки: At 12 weeks]
• Monitoring the related toxicity for the therapy Grade 3-4 [Срок оценки: 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 [Срок оценки: Up to 4 weeks after the last dose of rituximab]
• Efficacy of rituximab on prolongation of event-free survival [Срок оценки: Up to 1 year]
• Efficacy of rituximab on prolongation of overall survival [Срок оценки: Up to 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• M D Anderson Cancer Center — Houston

Публикации

• 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. PMID 21821712

Идентификаторы

NCT: NCT00412594 · 2004-0223 · NCI-2012-01394 · 2004-0223

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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