What side effects are associated with this type of intervention?

Common treatments for Chronic Lymphocytic Leukemia (CLL) include Janus Kinase inhibitors like Ruxolitinib, as well as other targeted therapies such as venetoclax and ibrutinib. Ruxolitinib can cause side effects like cytopenias, infections, and potential withdrawal syndrome. Venetoclax is associated with tumor lysis syndrome, neutropenia, and gastrointestinal issues. Ibrutinib may lead to bleeding complications, atrial fibrillation, and hypertension. Patients should discuss these potential side effects with their healthcare provider to make informed treatment decisions.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Lymphocytic Leukemia (CLL), including targeted therapies and immunotherapies. Notably, ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, and venetoclax, a BCL-2 inhibitor, have been approved for CLL. While Ruxolitinib Phosphate, a JAK inhibitor, is being studied for its efficacy in reducing fatigue in CLL patients, it is not yet approved for this indication. Other approved treatments include chemoimmunotherapy regimens such as fludarabine, cyclophosphamide, and rituximab (FCR), and bendamustine plus rituximab (BR). These therapies aim to target specific pathways involved in CLL cell survival and proliferation.

What other types of research exist?

Promising alternatives to Ruxolitinib Phosphate for CLL patients include BTK inhibitors (ibrutinib, acalabrutinib, zanubrutinib), venetoclax (often combined with obinutuzumab), and monoclonal antibodies (rituximab, obinutuzumab). These therapies have shown high efficacy in clinical trials, with BTK inhibitors providing durable single-agent activity and venetoclax achieving high rates of undetectable minimal residual disease.

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Janus Kinase (JAK) Inhibitor

Ruxolitinib Phosphate for Chronic Lymphocytic Leukemia Fatigue

Phase 2

Waitlist Available

Led By Zeev Estrov

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

Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Subjects must be diagnosed with CLL and do not meet the IWCLL criteria for treatment

Must not have

Females of non-childbearing potential are defined as women who (a) are equal to or greater than 55 years of age with history of amenorrhea for 1 year, or (b) are surgically sterile for at least 3 months

Females who are pregnant or are currently breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well ruxolitinib phosphate works in reducing fatigue in patients with chronic lymphocytic leukemia. The medication blocks a protein that helps cancer cells grow, which might also help with tiredness and other symptoms. Patients take the medication regularly unless their disease gets worse or they experience severe side effects.

Who is the study for?

This trial is for patients with chronic lymphocytic leukemia who experience fatigue, have stable blood counts, and are not in immediate need of CLL treatment. They must understand the study and consent to participate. Pregnant or breastfeeding women, those with recent serious illnesses or infections, and individuals on certain medications are excluded.

What is being tested?

The trial tests Ruxolitinib Phosphate's effectiveness in reducing fatigue associated with chronic lymphocytic leukemia by blocking a protein called JAK that cancer cells need to grow. It also evaluates changes in lymph node size and leukemia cell counts.

What are the potential side effects?

Ruxolitinib may cause side effects such as low blood cell counts leading to increased infection risk, anemia causing tiredness, bruising or bleeding issues due to low platelets, liver function abnormalities, kidney problems and potential drug interactions.

Eligibility Criteria

Inclusion Criteria

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

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I am able to care for myself and perform daily activities.

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I have been diagnosed with CLL but do not require treatment yet.

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I experience noticeable symptoms from my condition.

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I stopped all CLL treatments 30 days ago.

Exclusion Criteria

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

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I am a woman over 55 with no menstrual period for a year or have been surgically sterile for 3 months.

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I am not pregnant or breastfeeding.

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I have a heart condition that is not well-controlled.

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I have been treated with JAK inhibitor therapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months

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

Treatment Details

Study Objectives

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

Primary study objectives

Change in fatigue

Secondary study objectives

20% improvement in symptoms

Proportion of patients with 2 point reductions in the BFI #3 score

Side effects data

From 2021 Phase 2 trial • 71 Patients • NCT01431209

23%

anemia

13%

Fever

11%

platelet count decreased

neutrophil count decreased

sepsis

lymphocyte count decreased

dyspnea

thromboembolic event

fever

hypoxia

hypercalcemia

hypophosphatemia

Acute kidney injury

sinus tachycardia

respiratory failure

fatigue

lung infection

ileus

hypotension

anorexia

cognitive disturbance

Investigations

pneumonitis

hypertension

Hepatobiliary - Other

nausea

dizziness

abdominal pain

diarrhea

pain in extremity

confusion

creatinine increased

delirium

pleural effusion

upper respiratory infection

vomiting

wound infection

Fall

cardiac disorder, Other

seizure

skin infection

syncope

tumor lysis syndome

Infections and infestiations - Other

Anemia

Musculoskeletal, Other

fracture

gait disturbance

gastric hemorrhage

sore throat

leukemia secondary to oncology chemotherapy

lymphedema

100%

80%

60%

40%

20%

Study treatment Arm

Diffuse Large B-cell Lymphoma (DLBCL)

Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)

Awards & Highlights

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: Supportive care (ruxolitinib phosphate)Experimental Treatment2 Interventions

Patients receive ruxolitinib phosphate PO BID (approximately 12 hours apart) for up to 2 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruxolitinib Phosphate

2011

Completed Phase 2

~390

0 / 8Eligibility 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 Chronic Lymphocytic Leukemia (CLL) include targeted therapies such as BTK inhibitors (e.g., ibrutinib), BCL-2 inhibitors (e.g., venetoclax), and JAK inhibitors (e.g., ruxolitinib phosphate). BTK inhibitors work by blocking Bruton's tyrosine kinase, a protein essential for B-cell receptor signaling, thereby inhibiting the growth and survival of CLL cells. BCL-2 inhibitors promote apoptosis in CLL cells by targeting the BCL-2 protein, which prevents programmed cell death. JAK inhibitors, like ruxolitinib, block Janus kinase enzymes involved in the signaling pathways that promote cancer cell growth and survival. These mechanisms are crucial for CLL patients as they offer more precise and effective treatment options with potentially fewer side effects compared to traditional chemotherapy, improving patient outcomes and quality of life.

Agony of choice-selecting chronic lymphocytic leukemia treatment in 2022.Targeted therapy in the treatment of chronic lymphocytic leukemia: facts, shortcomings and hopes for the future.A critical appraisal of ibrutinib in the treatment of mantle cell lymphoma and chronic lymphocytic leukemia.