Clinical trial · Interventional
Perifosine in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Phase II Trial of Perifosine in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
NCT00873457CI-TRIAL-00010436completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Perifosine inhibits the AKT pathway (a way cells communicate with each other). This pathway is felt to be important in the development of several types of cancers including chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It is thought perifosine may be able to block this pathway and lead to an improvement in the CLL or SLL. The purpose of this trial is to see if perifosine is an effective treatment for relapsed or refractory CLL or SLL. Another purpose of this study is to look at the effect perifosine has on cells.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| perifosine | Drug | Perifosine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Perifosine
- description
- Perifosine 50 mg twice a day for a total of six 28-day cycles.
- interventionNames
- Drug: perifosine
Primary outcomes (2)
- measure
- Overall Response
- timeFrame
- after 3 months of treatment
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 estimated or measured creatinine clearance ≥30 ml/min at study enrollment. * AST, ALT, and total bilirubin ≤ 2.5 times the upper limit of normal, unless due to CLL/SLL. * Female subject who is either post-menopausal or surgically sterilized or male or female subject willing to use an acceptable method of birth control for the duration of the study therapy and for 2 weeks after study therapy completion. Exclusion Criteria: * Female subject is pregnant or lactating. * Patient has received other investigational drugs for this disease within 14 days of enrollment. * Patient with known HIV prior to enrollment. * Serious medical or psychiatric illness likely to interfere with participation in this clinical study. * Patients with another malignancy within the last three years (from documentation of remission) other than basal or squamous cell skin cancer or CIS of the cervix or early stage prostate cancer not requiring systemic treatment. * Patients who underwent allogeneic stem cell transplant and have at least 2% donor cells engrafted will be excluded. * Significant cardiac or vascular events within 6 months: acute MI, unstable angina, severe peripheral vascular disease (ischemic pain at rest class 3 or worse, non-healing ulcers/wounds, congestive heart failure (NHYA class ≥ 2), uncontrolled cardiac arrhythmias. * Known severe hypersensitivity to perifosine or any component of the formulation. * Life expectancy less than six months due to co-morbid illness * Active autoimmune hemolytic anemia or immune thrombocytopenia, requiring current steroid therapy. * De novo prolymphocytic leukemia (PLL) or PLL arising from CLL (≥ 55% prolymphocytes). * Richter's transformation
References
Publications (0)
Data not yet available
No reference posted for this study.