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....
Drug: Yttrium-Daclizumab (CHX-A Daclizumab)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy 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|
- Assess safety and adverse events assoc with 90Y-daclizumab radioimmunotherapy (RIT) in combination w/BEAM and ASCT.
- Determine MTD in mCi of 90Y-daclizumab RIT in combination w/BEAM and ASCT.
- Assess the frequency of the failure to engraft, myelodysplastic syndrome (MDS), secondary leukemia.
- Estimate response rate in patients with refractory or relapsed HD to 90Y-daclizumab RIT in combination w/BEAM and ASCT.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||September 2021|
|Estimated Primary Completion Date:||September 2021 (Final data collection date for primary outcome measure)|
|Contact: Tatyana Worthy, R.N.||(301) firstname.lastname@example.org|
|Contact: Thomas A Waldmann, M.D.||(301) email@example.com|
|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)|