Ibrutinib in Treating Patients With Relapsed Hairy Cell Leukemia (NCT01841723) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Ibrutinib in Treating Patients With Relapsed Hairy Cell Leukemia
United States44 participantsStarted 2013-04-30
Plain-language summary
This phase II trial studies how well ibrutinib works in treating patients with hairy cell leukemia that has returned after a period of improvement. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically confirmed diagnosis of hairy cell leukemia or variant according to World Health Organization (WHO) criteria with any of the following indications for therapy:
* Hemoglobin \< 11 g/dL
* Platelet count \< 100,000/mL
* Absolute neutrophil count \< 1,000/mL
* Progressive or symptomatic splenomegaly or hepatomegaly
* Enlarging lymphadenopathy \>= 2 cm
* Absolute lymphocyte count \> 5,000/mL
* Disease related constitutional symptoms consisting of unexplained weight loss exceeding 10% of body weight over the preceding 6 months, Cancer Therapy Evaluation Program (CTEP) active version of the Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or 3 fatigue, fevers \> 100.5 degrees Fahrenheit (F) or night sweats for greater than 2 weeks without evidence of infection
* Patients with classic hairy cell leukemia may receive therapy under the following conditions:
* After at least 1 prior purine nucleoside analog-containing regimen (fludarabine, pentostatin, or cladribine), or
* Relapsed or de novo disease if deemed medically unfit for therapy with a purine nucleoside analog
* Because there is no recognized standard of care for patients with variant hairy cell leukemia, both previously treated and previously untreated patients with this diagnosis will be eligible
* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of ibrutinib in patients \< 18 years of age, children are exclud…
What they're measuring
1
Overall response rate (complete response [CR] and partial response [PR])