EL625 in Persistent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Part of paid clinical trials in Durham, North Carolina.

Sponsor
David Rizzieri
Study ID
NCT00636155
Phase
PHASE2
Status
Terminated

Conditions

  • Leukemia, Lymphocytic, Chronic
  • Lymphoma, Small Lymphocytic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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
  • Rituximab — DRUG
    375 mg/m2 on day 2
  • Cyclophosphamide — DRUG
    250 mg/m2 on days 2, 3, and 4
  • Fludarabine — DRUG
    25 mg/m2 on days 2, 3, and 4

Study Details

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)

Key Dates

Start date
Feb 29, 2008
Status verified
Nov 2012
Primary completion
Aug 31, 2011
Completion
May 31, 2012

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: all patients
    EL625 combined with traditional chemotherapy (rituximab, fludarabine, and cyclophosphamide)

Primary Outcome Measure

Number of Patients With an Overall Response (Complete Response + Partial Response) [ Time Frame: every 3 cycles ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By research site
Duke University Medical Center· Durham, NC

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