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

Completed · Phase 1/Phase 2

Conditions studied: Lymphoma, Leukemia

In brief

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 facts

Study ID

NCT00048737

Run by

M.D. Anderson Cancer Center

People needed

70

Starts

2002-10-01

Expected to finish

2011-12-01

Last updated by the study team

2013-06-13

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients in relapse or considered at high risk for relapse or refractory CD-20-positive B-cell NHL or CLL. Patients considered for high risk of relapse are patients who do not achieve complete response (CR) with frontline chemotherapy, CLL is Richter's and CLL with high risk chromosomal abnormalities.
• Measurable disease.
• Age 18-70 years, expected survival >/= 3 months, performance status 0 to 2.
• Availability of a matched related donor.
• </+ 50% bone marrow involvement.
• CLL with </+ 10,000 circulating lymphocytes.
• Availability of a matched related or unrelated donor.

You may not qualify if…

• Prior myeloablative therapies or radioimmunotherapy.
• Prior external beam radiation therapy to >25% of active bone marrow.
• Prior therapy with 90Y Zevalin or Campath.
• CNS lymphoma, HIV, HTLV-1 positivity, some creatinine >1.6 mg/dl or serum bilirubin >1.5 mg/dl.
• Pregnancy or lactation.
• Symptomatic pulmonary or cardiac disease.

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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