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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Biogen
• Treatments: Antibodies, Monoclonal; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Rituximab; Vidarabine

Criteria

Inclusion Criteria:

1. 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.

2. Measurable disease.

3. Age 18-70 years, expected survival >/= 3 months, performance status 0 to 2.

4. Availability of a matched related donor.

5.

6. CLL with

7. Availability of a matched related or unrelated donor.

Exclusion Criteria:

1. Prior myeloablative therapies or radioimmunotherapy.

2. Prior external beam radiation therapy to >25% of active bone marrow.

3. Prior therapy with 90Y Zevalin or Campath.

4. CNS lymphoma, HIV, HTLV-1 positivity, some creatinine >1.6 mg/dl or serum bilirubin >1.5 mg/dl.

5. Pregnancy or lactation.

6. Symptomatic pulmonary or cardiac disease.