Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
perifosine · 1 trial · 2 indications
Per International Workshop on Chronic Lymphocytic Leukemia, Complete Response (CR):normal CBC; absence of the following: clonal lymphocytes in blood and marrow, lymphadenopathy, hepatomegaly or splenomegaly, and constitutional symptoms; and bone marrow has \<30% lymphocytes, is normocellular, and is without B-lymphoid nodules. Partial Response(PR): one of the following: decrease lymphadenopathy ≥ 50%; decrease of liver and/or spleen size ≥ 50%, any constitutional symptoms, Polymorphonuclear leukocytes ≥ 1,500/µl or a 50% improvement, or decrease of circulating clonal B lymphocytes ≥ 50% AND one of the following: Platelets ≥ 100,000/µl or a 50% improvement, Hemoglobin ≥ 11.0 g/dl or a 50% improvement, Bone marrow has ≥ 30% lymphocytes, or B-lymphoid nodules, or not done. Overall Response (OR)= CR+PR
| Arm | Type | Description |
|---|---|---|
| Perifosine | EXPERIMENTAL | Perifosine 50 mg twice a day for a total of six 28-day cycles. |
| Name | Type | Description |
|---|---|---|
| perifosine | DRUG | Perifosine 50 mg will be taken orally twice a day for a maximum of six 28-day cycles |
Inclusion Criteria: * A diagnosis of CLL or SLL based on iwCLL diagnostic criteria. * Prior therapy for CLL (no limit on number of prior regimens). * Patients requiring therapy, based on at least one of the iwCLL criteria. * 18 years of age or older. * Performance status ECOG 0, 1, or 2. * An estim...
Perifosine is an investigational small molecule being studied for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It was evaluated in a Phase 2 clinical trial for patients with relapsed or refractory disease. Perifosine is not approved by the FDA and remains in clinical development.
Perifosine is being developed by Akebia Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AKBA. The company sponsored a Phase 2 clinical trial of perifosine in chronic lymphocytic leukemia and small lymphocytic lymphoma.
Perifosine is in Phase 2 clinical development. A single Phase 2 trial in relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma has been completed. Perifosine is an investigational drug and has not received FDA approval.
Perifosine has been studied in one completed Phase 2 clinical trial, identified as NCT00873457, titled "Perifosine in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma." The trial enrolled 16 participants in the United States and was not randomized or blinded.
Perifosine is a small molecule that targets the AKT signaling pathway, which is involved in cell survival and proliferation. By inhibiting this pathway, perifosine is intended to induce apoptosis in cancer cells. The Phase 2 trial in chronic lymphocytic leukemia was biomarker-selected, indicating patient selection based on specific molecular markers.