Immunotherapy Following Reduced Intensity Conditioning and Allogeneic Stem Cell Transplant for Poor Risk CD30+ Hodgkin Lymphoma Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any - 45 |
| Updated: | 3/15/2019 |
| Start Date: | March 2014 |
| End Date: | December 2020 |
| Contact: | Mitchell Cairo, MD |
| Email: | mitchell_cairo@nymc.edu |
| Phone: | 914-594-2150 |
A Multicenter Pilot Study of Reduced Intensity Conditioning and Allogeneic Stem Cell Transplantation Followed by Targeted Immunotherapy in Children, Adolescents and Young Adults With Poor Risk CD30+ Hodgkin Lymphoma (HL)
Patients with relapsed or refractory Hodgkin Lymphoma who are CD30+ will receive a standard
of care reduced intensity regimen and an allogeneic stem cell transplant (from another
person, related or unrelated). Following recovery, patients will receive a medication called
Brentuximab Vendotin which is targeted against CD30+ cells. The study hypothesis is that this
treatment will be safe and well tolerated in children and young adults.
of care reduced intensity regimen and an allogeneic stem cell transplant (from another
person, related or unrelated). Following recovery, patients will receive a medication called
Brentuximab Vendotin which is targeted against CD30+ cells. The study hypothesis is that this
treatment will be safe and well tolerated in children and young adults.
Inclusion Criteria:
- 45 years of age or less.
- Patients with Hodgkin Lymphoma with either of the following:
• Primary induction failure (failure to achieve initial CR) and/or primary refractory
disease OR First, Second or Third relapse AND History of prior ablative auto HSCT or
ineligible for an ablative auto HSCT or ≥25% residual disease after at least two
reinduction chemotherapy cycles AND HLA matched family donor (6/6 or 5/6) or matched
unrelated adult donor (MUD) (8/8) or matched umbilical cord blood unit (≥5/6) with
prethaw cell dose of at least 3 x 107/kg TNC.
- off other investigational therapy for one month prior to entry in this study.
- adequate organ function
Exclusion Criteria:
- Patients with HD with 4th or greater CR, PR, and/or SD are ineligible.
- Patients with rapidly progressive disease (PD) unresponsive to reinduction chemo,
radio, or immunotherapy are ineligible.
- Patients who don't have an eligible donor are ineligible.
- Women who are pregnant are ineligible.
We found this trial at
1
site
40 Sunshine Cottage Road
Valhalla, New York 10595
Valhalla, New York 10595
(914) 594-4000
Phone: 914-594-2150
New York Medical College The College was founded in 1860 by a group of New...
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