Weekly Subcutaneous Alemtuzumab and Rituximab for Relapsed CLL

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT00330252
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    Given intravenously on day 1 of every week for eight weeks (or 16 weeks)
  • Alemtuzumab — DRUG
    Drug: Alemtuzumab Dosage will vary during Phase I of trial: Given intravenously on days 1, 3, and 5 for weeks one and two, on days 1 and 4 for weeks three and four and on day 1 for weeks five through eight. Participants may receive either one eight-week course of treatment or two eight-week courses of treatment (16 weeks).

Study Details

The purpose of this study is to determine whether the combination of alemtuzumab and rituximab is safe and effective in treating patients with relapsed Chronic Lymphocytic Leukemia (CLL) and to determine whether alemtuzumab can be given as a single weekly subcutaneous dose, together with rituximab.

Key Dates

Start date
May 31, 2006
Status verified
May 2016
Primary completion
Jan 31, 2013
Completion
Jan 31, 2014

Study Design

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

Arms

  • Experimental: Alemtuzumab & Rituximab
    Alemtuzumab Dosage will vary during Phase I of trial: Given intravenously on days 1, 3, and 5 for weeks one and two, on days 1 and 4 for weeks three and four and on day 1 for weeks five through eight. Participants may receive either one eight-week course of treatment or two eight-week courses of treatment (16 weeks) Rituximab- Given intravenously on day 1 of every week for eight weeks (or 16 weeks)

Primary Outcome Measure

Maximum tolerated dose of alemtuzumab given once weekly [ Time Frame: 2 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02115-

Find similar trials in Boston, MA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Beth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MA

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