Phase 2
Completed N=70
Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies
Source: ClinicalTrials.gov NCT00048737 ↗Enrolled (actual)
70
Serious AEs
10.0%
Results posted
Jun 2013
Primary outcomePrimary: Number of Participants With Graft Failure — 1 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Graft Failure |
1 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT00048737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.