The investigators expect to enroll 15 participants with relapsed or refractory IgM-associated AL amyloidosis onto this Phase II clinical trial. Idelalisib will be self-administered orally at a dose of 100 mg twice daily (may be increased to 150 mg (one tablet) twice daily after 3 months at investigator discretion). Participants will be treated until disease progression, unacceptable toxicity, or decision to withdraw from the trial. Disease evaluations will be performed every three months until disease progression.
Name: Idelalisib
Description: Idelalisib daily until unacceptable toxicity or disease progression.Type: DrugIdelalisib
Description: Evaluate hematologic response according to standard criteria
Measure: Overall Response Time: 3 monthsDescription: Evaluate time to progression
Measure: Progression Free Survival Time: 1 yearDescription: Number of patients with organ response using standard AL amyloidosis criteria.
Measure: Organ Response Time: 3 monthsDescription: Number of Participants With Treatment-Related Adverse Events as Assessed by Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0
Measure: Evaluate Safety and Tolerability of Agent Time: 3 monthsDescription: Evaluate quality of life according to Functional Assessment of Cancer Therapy Lymphoma Subscale (FACT-Lym) assessment tool
Measure: Quality of Life Time: 3 monthsSingle Group Assignment
There is one SNP
IgM paraprotein identified on serum immunofixation electrophoresis OR light chain-restricted CD20+ lymphoplasmacytic population on biopsy of bone marrow or lymph node (identified by H&E/immunohistochemistry or flow cytometry) OR positive myeloid differentiation primary response gene 88 (MYD88-L265P) OR CXCR4WHIM mutation (CXCR4 mutation - warts, hypogammaglobulinemia, infections, myelokathexis) on submitted samples 3.1.2 --- L265P ---