New combo aims to boost remission in leukemia

NCT ID NCT02514083

Ongoing Disease control Sponsor: National Heart, Lung, and Blood Institute (NHLBI) Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot phase 2 study tests a combination of ibrutinib (taken daily) and a short course of fludarabine (given in cycles 3 and 4) in 29 patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. The goal is to see how many patients achieve a complete response after 24 weeks and how many stop treatment due to side effects. Ibrutinib is continued long-term unless the disease worsens or side effects become intolerable.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Ibrutinib (Imbruvica) and fludarabine (Fludara)
What this could lead to: If successful, this combination could offer a more effective initial treatment for CLL/SLL, potentially leading to higher remission rates without long-term chemotherapy.
What could go wrong: This is a small, early-phase pilot study with only 29 participants. The combination may cause intolerable side effects, and results may not apply to all patients. Ibrutinib is taken indefinitely, so it is not a cure.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CHRONIC LYMPHOCYTIC LEUKEMIA SMALL LYMPHOCYTIC LYMPHOMA

Contacts and locations

Locations

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

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