EL625 in Persistent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

NCT00636155 | Terminated Phase 2 Results

• 1 other identifier: Pro00001363
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Lymphoma, Small Lymphocytic; Leukemia, Lymphocytic, Chronic

Keywords

Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia; EL625; cenersen

Outcome Measures

Primary Outcomes (1)

• Number of Patients With an Overall Response (Complete Response + Partial Response)

  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.

  every 3 cycles

Secondary Outcomes (2)

• Progression Free Survival

  5 years

• Overall Survival

  5 years

Study Arms (1)

all patients

EXPERIMENTAL

EL625 combined with traditional chemotherapy (rituximab, fludarabine, and cyclophosphamide)

Drug: cenersen sodium; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Fludarabine

Interventions

cenersen sodium DRUG

2.4 mg/kg/day as a continuous infusion over 24 hours starting on day one and ending on day 4

Also known as: EL625

all patients

Rituximab DRUG

375 mg/m2 on day 2

Also known as: Rituxan

all patients

Cyclophosphamide DRUG

250 mg/m2 on days 2, 3, and 4

Also known as: Cytoxan

all patients

Fludarabine DRUG

25 mg/m2 on days 2, 3, and 4

Also known as: Fludara

all patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• David Rizzieri: lead
• Eleos, Inc.: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Rituximab; Cyclophosphamide; fludarabine; fludarabine phosphate

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Mark Lanasa, MD, PhD
• Organization: Duke University Medical Center

mark.lanasa@duke.edu

919-286-6897

Study Officials

• David Rizzieri, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: January 22, 2008
• First Posted: March 14, 2008
• Study Start: February 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: May 1, 2012
• Last Updated: November 28, 2012
• Results First Posted: August 22, 2012

Record last verified: 2012-11

Locations

US (1)