drugset / Trial / NCT01468311

Yttrium-90-labeled Daclizumab With Chemotherapy and Stem Cell Transplant for Hodgkin's Lymphoma

NCT01468311

Phase 1/2 Terminated 6 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

Background: * Hodgkins lymphoma (HL) is a highly treatable cancer. However, if HL does not respond to chemotherapy or returns after chemotherapy, further treatments often are not successful. * Some HL cells have a molecule called cluster of differentiation 25 (CD25) on the surface. Daclizumab is a drug that can detect CD25 on cells. In a treatment study for HL that did not respond to chemotherapy, daclizumab plus a radioactive atom called Yttrium 90 helped kill these HL cells. Researchers want to combine this 90Y daclizumab with high-dose chemotherapy and stem cell transplant. This treatment may be more effective than the daclizumab alone. Objectives: \- To see if yttrium-90 daclizumab, high-dose chemotherapy, and stem cell transplants can treat HL that has not responded to earlier treatments. Eligibility: \- Individuals at least 18 years of age who have Hodgkins lymphoma that has not responded to chemotherapy. Design: * Participants will be screened with a physical exam and medical history. They will also have blood and urine tests. * Participants will have filgrastim and plerixafor to move stem cells into the blood. Stem cells will be collected with apheresis. * Four weeks after stem cells are collected, participants will have the 90Y daclizumab and normal daclizumab to treat the HL. Chemotherapy will start 9 days after the first treatment. * Most participants will have a second dose of 90Y daclizumab 6 weeks after the first dose. * After each daclizumab treatment, participants will have several imaging studies of the chest and abdomen. Blood samples will also be collected. * On the day after the last day of chemotherapy, participants will receive the stem cells collected earlier. Filgrastim injections will help stimulate stem cell growth....

Timeline

Start
2011-10-11
Primary completion
2014-11-16
Completion
2020-10-22

Drugs

EvaluationDrugModalityDoseRoute
Background Cytarabine Small molecule
Background Etoposide Small molecule
Background Melphalan Small molecule
Background carmustine Small molecule

Indications