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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Tolerability, Response and Best Response, Survival

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 2
~1950
Ibrutinib
2014
Completed Phase 3
~1880
Fludarabine
2012
Completed Phase 3
~1090

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,814 Previous Clinical Trials
47,290,860 Total Patients Enrolled
Adrian U Wiestner, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)

Media Library

Fludarabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03204188 — Phase 2
Chronic Lymphocytic Leukemia Research Study Groups: Ibrutinib, Fludarabine, and Pembrolizumab in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia Clinical Trial 2023: Fludarabine Highlights & Side Effects. Trial Name: NCT03204188 — Phase 2
Fludarabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03204188 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What ailments commonly necessitate the use of Pembrolizumab?

"Pembrolizumab is commonly used for the treatment of unresectable melanoma and has been found to be beneficial in other cases such as microsatellite instability high, a heightened risk of recurrence, and general disease progression."

Answered by AI

Is enrollment ongoing for this research endeavor?

"Sadly, according to clinicaltrials.gov this particular medical research is no longer recruiting individuals for the trial. It was originally posted in September of 2017 and last updated on August 2nd 2022. Fortunately there are a substantial number (2347) of other studies that are still searching for participants at the moment."

Answered by AI

In what other research initiatives has Pembrolizumab been utilized?

"Currently, 1466 clinical trials are in progress concerning Pembrolizumab. Of these investigations, 165 are currently in phase 3. Although Houston is the main hub for this treatment's research and development, there exists 45691 different sites running related studies."

Answered by AI

How many participants are involved in this scientific experiment?

"Unfortunately, recruitment for this trial has now closed. Initially posted on September 22nd 2017 and most recently edited on August 2nd 2022, the study is no longer enrolling participants. For alternative options, 881 trials related to weight loss are actively recruiting patients at present and there are 1466 studies involving Pembrolizumab currently accepting applications from participants."

Answered by AI

Has the Food and Drug Administration (FDA) given their stamp of approval to Pembrolizumab?

"Pembrolizumab's safety is judged to be a 2, since it has only been tested in Phase 2 trials. There have not yet been any studies validating its efficacy."

Answered by AI
~2 spots leftby Mar 2025