Ibrutinib in Steroid Refractory Autoimmune Hemolytic Anemia (ISRAEL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03827603|
Recruitment Status : Active, not recruiting
First Posted : February 1, 2019
Last Update Posted : January 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|AIHA - Warm Autoimmune Hemolytic Anemia||Drug: Ibrutinib||Phase 2|
Subjects will give informed consent before any protocol specific assessments. Blood samples, physical examination, CT scan and bone marrow examination will be performed to determine baseline disease status and study eligibility. All examinations must be performed ≤ 14 days prior to first infusion, with the exception of the CT scan and bone marrow examination. The CT scan and the bone marrow examination will be performed within 6 weeks of first infusion.
treatment regimen: Rituximab 375 mg/m2 8 weekly infusions (days 1, 8, 15, 22, 29, 36, 43, 50, 57), then 3 infusion every 28 days (days 85, 113, 141) Ibrutinib 420 mg (3 tablets) daily, constantly for 6 months
Disease status assessments to determine subject response or progression will be performed monthly according to NCI Criteria and will include:
- Physical examination including lymph node examination, spleen and liver measurement, and detection of constitutional symptoms
- Peripheral blood sample evaluation of complete blood count (CBC) and differential (expressed in % and absolutes)
- Direct antiglobulin test
- In addition, subjects will be monitored for safety, efficacy.
After completion of the induction phase, subjects achieving CR or PR (for AIC and CLL) will continue maintenance phase. During maintenance phase patients will receive:
ibrutinib 420 mg (3 tablets) daily, constantly until progression or unacceptable toxicity Survival and disease status assessments will be performed 1 month post treatment and every 2 months until total observation time.
In addition, subjects will be monitored for safety and efficacy.
- Bone marrow examination is required for confirmation of CR 1 months post final rituximab infusion. Minimal Residual Disease (MRD) assessment of the bone marrow aspirate will also be performed for subjects demonstrating a CR.
- In PRCA patients with clinical evidence of response for anemia the bone marrow examination is required independently of CLL status at 1 month post last rituximab infusion.
- All subjects with clinical CR will receive MRD assessment of the peripheral blood during maintenance phase. In subjects achieved MRD-negative result in blood in two consecutive measurements bone marrow examination is required for confirmation of CR.
- CT-Scans will be performed for patients achieving a CR, PR or SD at 1 month post last rituximab infusion. CT-Scans must be repeated every 12 months beginning since final assessment of response after induction phase.
Follow-up assessment for subjects experiencing CLL progression or relapse of AIC during the maintenance phase requires a 1 month post-treatment safety assessment. Subsequent follow up visits include assessment of survival status, date of next CLL therapy, type of therapy and response to therapy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ibrutinib in Steroid Refractory Autoimmune Hemolytic Anemia: ELaboration of Treatment Approach|
|Actual Study Start Date :||February 21, 2017|
|Actual Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||March 31, 2022|
Experimental: patients with AIHA and CLL
patients with CLL and in Steroid Refractory AIHA receive ibrutinib 420 mg per day till progression or intolerance
Ibrutinib and rituximab combination for the treatment of steroid refractory AIC (warm type AIHA and PRCA) with underlying CLL.
Other Name: Imbruvica
- Response rate [ Time Frame: 3 month after treatment ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827603
|Moscow, Russian Federation, 125284|