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RecruitingPhase 2

Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 weeks, 1 year

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the side effects of cladribine and rituximab and how well they work together for adults with hairy cell leukemia. Cladribine is chemotherapy that stops cancer cell growth. Rituximab may help the body's immune system attack cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • A bone marrow test shows that you have hairy cell leukemia.
  • If your cancer has come back, you have had no more than one past treatment.
  • Women who could become pregnant must use birth control or avoid sex during the study.
  • Your ability to do daily activities must score 3 or lower on the study's scale.
  • Your creatinine level (a kidney test) must be 2.0 or lower, unless the disease causes the higher level.
  • Your liver tests must show bilirubin of 3.0 or lower and transaminases no more than 3 times the normal upper limit. Higher transaminases are allowed if caused by the disease.
  • You have not received an experimental drug in the 4 weeks before study treatment starts.

Who can't join

  • You cannot or do not want to sign the consent form.
  • You have a known HIV, hepatitis B, or hepatitis C infection.
  • You have an active infection.
  • Cancer has spread to your brain or spinal cord.
  • You have severe heart disease rated class III or IV on the New York Heart Association scale.
  • You have had chemotherapy in the past 4 weeks.

Simplified for readability. The official criteria below are what the study team uses.

Official 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)

Study sites (1)

TX