Allogeneic Stem Cell Transplantation With Adoptive Immunotherapy in Epstein-Barr Virus Positive Recurrent/Refractory Hodgkins Lymphoma



Status:Terminated
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 45
Updated:12/24/2017
Start Date:January 2013
End Date:December 2017

Use our guide to learn which trials are right for you!

A Multicenter Pilot Study of Reduced Intensity Allogeneic Stem Cell Transplantation Followed by Adoptive Cellular Immunotherapy With Donor Derived Latent Membrane Protein (LMP) Specific-CTLs in Patients With Epstein-Barr Virus (EBV)Positive Refractory or Recurrent Hodgkin Lymphoma

The investigators intend to utilize reduced intensity conditioning and allogeneic stem cell
transplant from EBV positive HLA matched sibling or unrelated adult donor combined with post
AlloSCT allogeneic donor derived LMP specific cytotoxic T-lymphocyte (CTL) infusions in EBV
positive patients with poor risk Hodgkin Lymphoma. One of three reduced intensity
conditioning regimens predetermined at each institutional center of the Childhood, Adolescent
and Young Adult Lymphoma Cell Therapy Consortium (LCTC) will be utilized for related or
matched unrelated adult donor allogeneic transplant followed by donor LMP specific CTL
infusion for three doses post AlloSCT. The investigators hypothesize that the addition of
donor derived LMP specific CTLs will be safe and feasible.


Inclusion Criteria:

Patient must be 45 years of age or less.

Patient or the patient's legally authorized guardian must be fully informed about their
illness and the investigational nature of the study protocol (including foreseeable risks
and possible side effects), and must sign an informed consent in accordance with the
institutional policies approved by the U.S. Department of Health and Human Services.

Patients should have been off other investigational therapy for one month prior to entry in
this study.

Patient must have adequate organ function as below

Adequate renal function defined as:

Serum creatinine <2.0 x normal, or Creatinine clearance or radioisotope GFR > 40 ml/min/m2
or >60 ml/min/1.73 m2 or an equivalent GFR as determined by the institutional normal range

Adequate liver function defined as:

Total bilirubin <2.0 x normal; and SGOT (AST) or SGPT (ALT) <5.0 x normal

Adequate cardiac function defined as:

Shortening fraction of >27% by echocardiogram

Hodgkin Lymphoma with either of the following:

Primary induction failure (failure to achieve initial CR) and/or primary refractory
disease.First relapse ; Early relapse (within 12 months off therapy) (excluding those who
received no therapy or radiation therapy only for initial therapy); Late relapse (greater
than 12 months off therapy). Only patients with recurrent Stage III or IV disease and/or
those with B symptoms at relapse (all other late relapses are excluded); Second relapse;
Third relapse.

History of prior ablative auto HSCT or ineligible for an ablative auto HSCT or ≥25%
residual disease after at least two reinduction chemotherapy cycles.

EBV seropositive IgG HLA matched family or unrelated donor (MUD) HLA matched family donor
(6/6 or 5/6) or matched unrelated adult donor (MUD) (7/8 or 8/8) All patients entered into
the study ideally will have tumor tissue from the original diagnostic specimen and/or
relapse reviewed centrally for confirmation of Hodgkin lymphoma. If no specimen is
available, local pathology report documenting EBV positivity is acceptable. Appropriate
immunophenotyping to confirm the diagnosis will be performed. In addition, in situ
hybridization for EBV (LMP1, and/or EBER positivity) will be performed. All central
morphologic analysis and immunohistochemical/insitu hybridization staining will be
performed in the laboratory of Sherrie Perkins and Rodney Miles at the University of Utah.

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.

EBV negative Hodgkin Lymphoma. Patients who don't have an eligible donor (outlined in 7.0)
are ineligible. Women who are pregnant are ineligible. Negative pregnancy test in women of
childbearing age is required.
We found this trial at
1
site
40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
New York Medical College The College was founded in 1860 by a group of New...
?
mi
from
Valhalla, NY
Click here to add this to my saved trials