MedTrace Logo

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

NCT00048737 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2013-06-13

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Zevalin Radioimmunotherapy

Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg

DRUG

Rituximab

250 mg/m\^2 on day 1 and day 8

DRUG

Fludarabine

30 mg/m\^2/day for 3 days

DRUG

Cyclophosphamide

750 mg/m\^2/day for 3 days, given on the same days as fludarabine, at 4-hour intervals

PROCEDURE

Allogeneic Stem Cell Transplantation

Allogeneic stem cell transplantation 2 days after chemotherapy

Sponsors & Collaborators

  • Biogen

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Issa F. Khouri, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00048737 on ClinicalTrials.gov