Ibrutinib in Steroid Refractory Autoimmune Hemolytic Anemia
Status:
Active, not recruiting
Trial end date:
2022-03-31
Target enrollment:
Participant gender:
Summary
This is an open-labeled, single arm, Phase II, two staged study of combination of ibrutinib
and rituximab in patients with autoimmune cytopenia and underlying CLL. In stage I (remission
induction) patients will receive ibrutinib and rituximab for 6 months; in stage II
(maintenance) - only ibrutinib until relapse, progression or unacceptable toxicity. A total
of 50 patients will be enrolled into the trial. The results will be compared to historical
control, efficacy of rituximab as monotherapy or in combination with chemotherapy in patients
with AIC and underlying CLL.