Ibrutinib in Steroid Refractory Autoimmune Hemolytic Anemia

NCT03827603 | Unknown Phase 2

• 1 other identifier: 54179060CLL2013
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

AIHA - Warm Autoimmune Hemolytic Anemia

Outcome Measures

Primary Outcomes (1)

• Response rate

  Response rate defined by transfusion independence, hemoglobin level, DAT and duration of response of autoimmunity (DR-AI), defined as the interval between time point of best response and relapse of AIC. Relapses of CLL will be censored.

  3 month after treatment

Study Arms (1)

patients with AIHA and CLL

EXPERIMENTAL

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

Drug: Ibrutinib

Interventions

Ibrutinib DRUG

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

Also known as: Imbruvica

patients with AIHA and CLL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Flow cytometry confirmation of immunophenotype with CD5, CD19, CD20, CD23, CD79b, and surface Ig prior to Visit 2
• Proven diagnosis autoimmune hemolytic anemia or pure red cell aplasia
• Relapse of AIHA/PRCA after steroids, splenectomy or rituximab or refractoriness to glucocorticosteroid hormones
• No more than 2 lines of antileukemia treatment
• Hematology values must be within the following limits:
• Absolute neutrophil count 1000/mm3 independent of growth factor support
• Platelets 100.000/mm3 or 50.000/mm3 if bone marrow involvement independent of transfusion support in either situation
• Biochemical values within the following limits:
• Alanine aminotransferase and aspartate aminotransferase less 3 upper limit of normal (ULN)
• Total bilirubin less 1.5x ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
• Serum creatinine less 2 x ULN or estimated Glomerular Filtration Rate more 40 mL/min/1.73 m2
• Age ≥ 18 years
• ECOG Performance Status of 0-2
• Life expectancy of at least 6 months
• Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree to not donate sperm during and after the study. For females, these restrictions apply for 1 month after the last dose of study drug. For males, these restrictions apply for 3 months after the last dose of study drug.

Sponsors & Collaborators

• Eugene Nikitin: lead

Study Sites (1)

Eugene Nikitin

Moscow, 125284, Russia

Location

MeSH Terms

Interventions

ibrutinib

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: February 1, 2019
• Study Start: February 21, 2017
• Primary Completion: December 1, 2019
• Study Completion: March 31, 2022
• Last Updated: January 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)