Clinical Trials /

Immunotherapy Following Reduced Intensity Conditioning and Allogeneic Stem Cell Transplant for Poor Risk CD30+ Hodgkin Lymphoma Patients

NCT02098512

Description:

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.

Related Conditions:
  • Hodgkin Lymphoma
Recruiting Status:

Unknown status

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT02098512

Trial Eligibility

Document

Title

  • Brief Title: Immunotherapy Following Reduced Intensity Conditioning and Allogeneic Stem Cell Transplant for Poor Risk CD30+ Hodgkin Lymphoma Patients
  • Official Title: 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)

Clinical Trial IDs

  • ORG STUDY ID: NYMC 564
  • NCT ID: NCT02098512

Conditions

  • Hodgkin Lymphoma

Interventions

DrugSynonymsArms
Brentuximab VedotinAdcetrisAllogeneic Transplant and Immunotherapy
Reduced Intensity ConditioningAllogeneic Transplant and Immunotherapy

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Allogeneic Transplant and ImmunotherapyExperimentalWe intend to utilize reduced intensity conditioning and allogeneic stem cell transplant from HLA matched sibling or unrelated adult donor followed by post-AlloSCT Brentuximab Vedotin in patients with poor risk Hodgkin Lymphoma.
  • Brentuximab Vedotin
  • Reduced Intensity Conditioning

Eligibility Criteria

        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.
Maximum Eligible Age:45 Years
Minimum Eligible Age:N/A
Eligible Gender:All
Healthy Volunteers:Accepts Healthy Volunteers

Primary Outcome Measures

Measure:Safety
Time Frame:1 year
Safety Issue:
Description:Patients will be followed for one year for adverse events related to the administration of study drug.

Secondary Outcome Measures

Measure:To assess feasibility of developing a bank of LMP-specific CTLs from healthy donors
Time Frame:3 years
Safety Issue:
Description:A bank of from identified EBV positive donors will be established for potential use in current and future clinical trials in LMP-positive lymphomas. Annual review will occur to assess the feasibility of recruiting healthy donors to help build this cell line bank. If there are no cell lines developed within the first year, an alternative design may be considered.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Unknown status
Lead Sponsor:New York Medical College

Trial Keywords

  • Brentuximab Vedotin
  • Immunotherapy
  • Relapsed Hodgkin Lymphoma
  • Refractory Hodgkin Lymphoma
  • Reduced Intensity Conditioning
  • Allogeneic Stem Cell Transplantation

Last Updated

March 13, 2019