Clinical trial · Interventional
EL625 in Persistent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
A Phase II Study of EL625 in Patients in Persistent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
NCT00636155CI-TRIAL-00008547terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): funding
Summary
Brief summary (as posted)
The purpose of this research study is to see if the investigational drug EL625, when combined with traditional chemotherapy (rituximab, fludarabine, and cyclophosphamide), is effective in Persistent Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)
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 |
|---|---|---|---|
| Leukemia, Lymphocytic, Chronic | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Small Lymphocytic | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cenersen sodium | Drug | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- all patients
- description
- EL625 combined with traditional chemotherapy (rituximab, fludarabine, and cyclophosphamide)
- interventionNames
- Drug: cenersen sodium
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Fludarabine
Primary outcomes (1)
- measure
- Number of Patients With an Overall Response (Complete Response + Partial Response)
- timeFrame
- every 3 cycles
- description
- Overall Response is the total number of participants with a Complete (CR) or Partial (PR) response. CR requires the absence of lymphadenopathy, hepatomegaly or splenomegaly and constitutional symptoms and a normal CBC; bone marrow must be at least normocellular for age, with less than 30% nucleated cells being lymphocytes with no lymphoid nodules. Partial Response: requires ≥ 50% decrease in one of the following: peripheral blood lymphocyte count, lymphadenopathy, enlargement of liver and/or spleen, or bone marrow involvement by CLL AND at least one hematologic parameter met for 2 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a diagnosis of CLL/SLL who have received at least one prior treatment regimen and have persistent disease (i.e. any evidence of active disease). Patients with a chromosome 17 abnormality or a p53 mutation of any type may be enrolled without having received prior treatment. * Patients must be 18 years of age or older. * Patient has an estimated or measured creatinine clearance ≥30 ml/min at study enrollment. * AST, ALT, total bilirubin \< than 2.5 times the upper limit of normal. * WBC \> 1.5; ANC \>500; Plt \>50,000 unless documented as due to disease * ECOG performance status of 0-2. * Voluntary written informed consent before performance of any study-related procedure not part of normal medical care. * Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for 2 weeks after administration of the study drug. * Male subject agrees to use an acceptable method for contraception for the duration of the study therapy and for 2 weeks after administration of study drug. Exclusion Criteria: * Female who is pregnant or lactating. * 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, resected early stage prostate cancer not requiring systemic treatment or CIS of the cervix or fully treated early stage prostate cancer. * 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 (NYHA class ≥ 2), uncontrolled cardiac arrhythmias, and disseminated intravascular coagulation. * Patients who are unable to refrain from taking acetaminophen * Investigational agent within 14 days of enrolling on the study. * Patients unable or unwilling to refrain from antioxidants including vitamin A, vitamin C, vitamin E, lycopene, lutein, grape seed extract, pycnogenol, green tea extract, and the like. * Patients who have received a prior allogenic stem cell transplant and have at least 2.5% donor cells still evident on engraftment studies.
References
Publications (0)
Data not yet available
No reference posted for this study.