Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00048737
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Zevalin Radioimmunotherapy — DRUG
    Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg
  • Rituximab — DRUG
    250 mg/m\^2 on day 1 and day 8
  • Fludarabine — DRUG
    30 mg/m\^2/day for 3 days
  • Cyclophosphamide — DRUG
    750 mg/m\^2/day for 3 days, given on the same days as fludarabine, at 4-hour intervals
  • Allogeneic Stem Cell Transplantation — PROCEDURE
    Allogeneic stem cell transplantation 2 days after chemotherapy

Study Details

The goal of this clinical research study is to see if low intensity chemotherapy given together with the new drug 90Y Zevalin, followed by a transplant of blood or marrow stem cells from a donor can increase the length of remission in patients with leukemia and lymphoma. The safety of this treatment will also be studied.

Key Dates

Start date
Oct 31, 2002
Status verified
Jun 2013
Primary completion
Dec 31, 2011
Completion
Dec 31, 2011

Study Design

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

Arms

  • Experimental: 90Y Zevalin in ASCT
    Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.

Primary Outcome Measure

Number of Participants With Graft Failure [ Time Frame: 100 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
MD Anderson Cancer Center· Houston, TX

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