UnknownPhase 2

Ibrutinib in Steroid Refractory Autoimmune Hemolytic Anemia

Russia50 participantsStarted 2017-02-21

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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:

What they're measuring

Response rate

Timeframe: 3 month after treatment

Trial details

NCT IDNCT03827603

SponsorEugene Nikitin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-01

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