Rituximab to the Preparative Regimen of Etoposide and Total Body Irradiation in Acute Lymphoblastic Leukemia

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00427791
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Etoposide — DRUG
    60 mg/kg IV Daily Over 4 Hours for 1 Day
  • Total Body Irradiation — RADIATION
    3 Gy Daily for 4 Days
  • Rituximab — DRUG
    375 mg/m\^2 IV Weekly Over 4-8 Hours for 4 Weeks

Study Details

Primary Objective: * To determine the progression free survival (PFS) of the preparative regimen rituximab, etoposide and total body irradiation (TBI), in patients with acute lymphoblastic leukemia (ALL) receiving allogeneic hematopoietic stem cell transplantation (SCT). Secondary Objectives: * To determine the effect of rituximab on the incidence of acute graft vs. host disease (GVHD). * To determine the efficacy of adding imatinib mesylate post transplant in ALL patients with the t(9;22)(q34;q11) cytogenetic abnormality. * To estimate the probability of molecular complete remission at one year for the described treatment approach as determined by serial minimal residual disease (MRD) monitoring. * To determine the rate of GVHD, engraftment, toxicity, and overall survival (OS) for this treatment regimen.

Key Dates

Start date
Jul 31, 2005
Status verified
Apr 2012
Primary completion
Oct 31, 2009
Completion
Oct 31, 2009

Study Design

Enrollment
23 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Etoposide + Total Body Irradiation + Rituximab
    Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m\^2 IV Weekly Over 4-8 Hours for 4 Weeks
  • Experimental: Etoposide + Total Body Irradiation
    Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: 2 Years post transplant or until disease progression or death ]

Locations (1)

FacilityCityStateZIPSite coordinators
U.T.M.D. Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
U.T.M.D. Anderson Cancer Center· Houston, TX

Related Studies