Loading clinical trials...

Allogeneic Stem Cell Transplantation With Adoptive Immunotherapy in Epstein-Barr Virus Positive Recurrent/Refractory Hodgkins Lymphoma | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

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

NCT01636388•New York Medical College

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

0 - 45 years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

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.

Locations (1)

New York Medical College

Valhalla, New York, United States

Key Dates

Start Date

January 1, 2013

Primary Completion Date

June 1, 2017

Completion Date

December 1, 2017

Last Updated

December 22, 2017

Enrollment

ACTUAL participants

Conditions

Hodgkins Lymphoma

Interventions

allogeneic donor derived LMP specific cytotoxic T-lymphocyte

BIOLOGICAL

Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

NCT03314974

Acute LeukemiaAcute Myeloid Leukemia+26 more

View study

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL)

NCT04661007

Non Hodgkins LymphomaDiffuse Large B-cell Lymphoma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL)

Resiliency in Older Adults Undergoing Bone Marrow Transplant

Conditioning Regimen and the Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematologic Malignancies.

Study of the Efficacy and Safety of Ublituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Study of 90Y-hLL2 to Treat Non-Hodgkin's Lymphoma