Yttrium-90-labeled Daclizumab With Chemotherapy and Stem Cell Transplant for Hodgkin s Lymphoma
- Hodgkin s 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 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.
- To see if yttrium-90 daclizumab, high-dose chemotherapy, and stem cell transplants can treat HL that has not responded to earlier treatments.
- Individuals at least 18 years of age who have Hodgkin s lymphoma that has not responded to chemotherapy.
- 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....
Procedure: Auto stem cell transplant
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Trial of Yttrium-90-labeled Daclizumab (Anti-CD25) Radioimmunotherapy With High-dose BEAM Chemotherapy and Autologous Hematopoietic Stem Cell Rescue in Recurrent and Refractory Hodgkin s Lymphoma|
- safe tolerated dose of 90Y-daclizumab w BEAM and ASCT [ Time Frame: after 1st dose of 90Y-daclizumab ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||September 2021|
|Estimated Primary Completion Date:||September 2020 (Final data collection date for primary outcome measure)|
Yttrium-90-labeled Daclizumab + BEAM + ASCT
Procedure: Auto stem cell transplant
Auto stem cell transplant (ASCT) is given after 90Y-daclizumabDrug: BEAM
BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumabRadiation: 111In-daclizumab
111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.Radiation: 90Y-daclizumab
90Y-daclizumab administered with a fixed dose of Ca-DTPA followed by BEAM Chemo and Auto stem cell transplant
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01468311
|Contact: Tatyana Worthy, R.N.||(301) email@example.com|
|Contact: Thomas A Waldmann, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937|
|Principal Investigator:||Thomas A Waldmann, M.D.||National Cancer Institute (NCI)|