Know Cancer

or
forgot password

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


Phase 2
N/A
45 Years
Open (Enrolling)
Both
Hodgkins Lymphoma

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Outcome Description:

The number of serious adverse events associated with administering allogeneic HLA matched donor derived LMP specific-CTLs in CAYA with EBV-associated refractory/relapsed HL following reduced intensity conditioning (RIC) and allogeneic HSCT will be monitored to determine the safety of this treatment.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Mitchell S Cairo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York Medical College

Authority:

United States: Food and Drug Administration

Study ID:

NYMC-553

NCT ID:

NCT01636388

Start Date:

March 2013

Completion Date:

December 2015

Related Keywords:

  • Hodgkins Lymphoma
  • Relapsed Hodgkins Lymphoma
  • Refractory Hodgkins Lymphoma
  • Allogeneic Stem Cell Transplantation
  • Adoptive Immunotherapy
  • Cellular Therapy
  • Cytotoxic T cell lymphocytes
  • Hodgkin Disease
  • Lymphoma

Name

Location

New York Medical CollegeValhalla, New York  10595