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Anti-metabolites

Triple Drug Therapy for Chronic Lymphocytic Leukemia

Phase 2

Waitlist Available

Led By Adrian U Wiestner, M.D.

Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)

Eligibility Criteria Checklist

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

Must have

Active disease meeting at least one of the specified IWCLL consensus criteria

Individuals greater than or equal to 18 years old

Must not have

Major surgery within 4 weeks of first dose of study drug

Known additional malignancy that is progressing or requires active treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to treat leukemia. The drugs are ibrutinib, fludarabine, and pembrolizumab. The trial is open to patients with leukemia who have not responded to other treatments.

Who is the study for?

This trial is for adults with active, high-risk or relapsed/refractory Chronic Lymphocytic Leukemia (CLL) who meet specific criteria including weight loss, presence of certain mutations, progressive symptoms, and adequate organ function. Participants must not have a history of certain infections or conditions that could affect the study's safety or outcomes.

What is being tested?

The trial tests a combination treatment for CLL using Ibrutinib continuously from cycle -3 until progression/intolerable side effects; Fludarabine on days 1-5 in cycle -2 only; Pembrolizumab every 3 weeks starting from cycle 1 for one year. The goal is to achieve greater reduction in CLL cells and restore immune response.

What are the potential side effects?

Potential side effects include reactions related to the immune system such as inflammation in various organs, infusion-related reactions, fatigue, digestive issues like nausea and diarrhea, blood disorders like anemia or bleeding problems due to low platelet counts.

Eligibility Criteria

Inclusion Criteria

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

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My condition meets one of the required criteria for active disease.

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I am 18 years old or older.

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I am fully active or have some restrictions but can still take care of myself.

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I have been diagnosed with CLL or SLL.

Exclusion Criteria

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

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I have not had major surgery in the last 4 weeks.

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I have another cancer that is getting worse or needs treatment.

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I am not pregnant, breastfeeding, and I am willing to use contraception.

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I have a serious illness or a condition that affects how my organs work.

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I am a male and unwilling to follow contraception guidelines.

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I have a serious liver condition right now.

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I have not needed treatment for an autoimmune disease in the last 2 years.

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I need to take blood thinners like Coumadin.

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I understand the study's purpose and can give informed consent.

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My CLL has transformed into a non-Hodgkin lymphoma.

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I do not have major digestive system issues or related surgeries.

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I have had lung inflammation treated with steroids.

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I have a serious heart condition that is currently affecting me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants With Complete Response of the Combination of Ibrutinib, Fludarabine, and Pembrolizumab in Patients With High-risk and/or Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Leukemia

Secondary study objectives

Tolerability, Response and Best Response, Survival

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: Ibrutinib, Fludarabine, and Pembrolizumab in Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaExperimental Treatment3 Interventions

Ibrutinib, Fludarabine, and Pembrolizumab combination therapy will be administered in participants with High-Risk or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL). Ibrutinib will be administered daily by mouth starting cycle -3 at 420 mg until end study or disease progression or intolerable side effects occur. Fludarabine will be administered intravenously only on cycle -2 at 25mg/m\^2 x5 days. Pembrolizumab will be administered intravenously every 3 weeks at 200 mg starting from cycle 1 through cycle 17 or 1 year of immunotherapy phase.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

Ibrutinib

2014

Completed Phase 4

~2060