What side effects are associated with this type of intervention?

The most common treatments for Hairy Cell Leukemia include cladribine and rituximab. Cladribine, a chemotherapy agent, can cause side effects such as myelosuppression (leading to low blood counts), increased risk of infections, fever, and potential bone marrow hypoplasia or aplasia. Rituximab, an immunotherapy, may lead to infusion reactions, which can be severe, especially during the first cycle, and include symptoms like fever, chills, and low blood pressure. Both treatments aim to kill cancer cells and support the immune system in attacking the cancer, but they come with significant risks that need to be managed under medical supervision.

What prior FDA approvals exist?

Cladribine, a purine analog, has been FDA-approved as a standard first-line treatment for Hairy Cell Leukemia due to its effectiveness in killing cancer cells and preventing their division and spread. Rituximab, an anti-CD20 monoclonal antibody, is used in combination with chemotherapy for its ability to enhance the immune system's attack on cancer cells and interfere with tumor growth. This combination therapy has been effective in treating relapsed or refractory HCL, offering a comprehensive approach to disease management.

What other types of research exist?

Promising novel alternatives for Hairy Cell Leukemia treatment in 2024 include BTK inhibitors (e.g., ibrutinib, acalabrutinib, zanubrutinib) and BCL-2 inhibitors (e.g., venetoclax). These targeted therapies have shown high efficacy and improved tolerability in other hematologic malignancies. Additionally, newer monoclonal antibodies like obinutuzumab and CAR T-cell therapies are emerging as effective options. These treatments offer novel mechanisms of action and have the potential to provide better outcomes for HCL patients.

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Anti-metabolites

Cladribine + Rituximab for Hairy Cell Leukemia

Q: What is the mechanism of action of this treatment?

The most common treatments for Hairy Cell Leukemia (HCL) include cladribine and rituximab. Cladribine, a chemotherapy agent, kills cancer cells, stops them from dividing, and prevents their spread. Rituximab, an immunotherapy, is a monoclonal antibody that targets CD20 on B-cells, aiding the immune system in attacking cancer cells and interfering with tumor cell growth and spread. These treatments are vital for HCL patients as they directly target and reduce the malignant cells, aiming to improve disease control and patient outcomes.

Phase 2

Recruiting

Led By Farhad Ravandi-Kashani

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years and older

Performance status =< 3

Must not have

Known infection with human immunodeficiency virus (HIV), hepatitis B or C

Presence of central nervous system (CNS) metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial studies how well two drugs, cladribine and rituximab, work together in treating patients with hairy cell leukemia. Cladribine helps stop cancer cells from growing, while rituximab helps the immune system attack cancer cells. The combination aims to be more effective in treating this type of leukemia.

Who is the study for?

This trial is for adults with hairy cell leukemia who may have had one prior therapy. They must not be pregnant and should agree to use birth control. Participants need a performance status of <=3, acceptable kidney and liver function tests, and no recent investigational drugs or active infections.

What is being tested?

The study is testing the combination of Cladribine (a chemotherapy drug) with Rituximab (an immunotherapy antibody) to see if they work better together in treating hairy cell leukemia by killing cancer cells or stopping their growth.

What are the potential side effects?

Possible side effects include reactions related to immune system activation by Rituximab, such as fever and chills, as well as typical chemotherapy-related issues from Cladribine like nausea, fatigue, infection risk increase due to low blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can take care of myself but cannot do any physical work.

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My leukemia was confirmed through a bone marrow test.

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My condition has returned, but I've only had one prior treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with HIV, hepatitis B, or hepatitis C.

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My cancer has spread to my brain or spinal cord.

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My heart condition severely limits my daily activities.

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I currently have an active infection.

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I haven't had chemotherapy in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy of rituximab in eradication of minimal residual disease after cladribine therapy, assessed by immunophenotyping of bone marrow and peripheral blood

Therapeutic procedure

Monitoring the related toxicity for the therapy Grade 3-4

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (cladribine and rituximab)Experimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

FDA approved

Cladribine

FDA approved

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Hairy Cell Leukemia (HCL) include cladribine and rituximab. Cladribine, a chemotherapy agent, kills cancer cells, stops them from dividing, and prevents their spread. Rituximab, an immunotherapy, is a monoclonal antibody that targets CD20 on B-cells, aiding the immune system in attacking cancer cells and interfering with tumor cell growth and spread. These treatments are vital for HCL patients as they directly target and reduce the malignant cells, aiming to improve disease control and patient outcomes.