Ibrutinib in Steroid Refractory Autoimmune Hemolytic Anemia

Conditions

• AIHA - Warm Autoimmune Hemolytic Anemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ibrutinib — DRUG
  Ibrutinib and rituximab combination for the treatment of steroid refractory AIC (warm type AIHA and PRCA) with underlying CLL.

Study Details

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.

Key Dates

Start date

Feb 21, 2017

Status verified

Jan 2020

Primary completion

Dec 1, 2019

Completion

Mar 31, 2022

Study Design

Enrollment

50 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: patients with AIHA and CLL
  patients with CLL and in Steroid Refractory AIHA receive ibrutinib 420 mg per day till progression or intolerance

Primary Outcome Measure

Response rate [ Time Frame: 3 month after treatment ]