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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by New York Medical College
Sponsor:
Collaborator:
St. Baldrick's Foundation
Information provided by (Responsible Party):
New York Medical College
ClinicalTrials.gov Identifier:
NCT02098512
First received: March 17, 2014
Last updated: April 29, 2015
Last verified: April 2015
  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.

Condition Intervention Phase
Hodgkin Lymphoma
Drug: Brentuximab Vedotin
Procedure: Allogeneic Stem Cell Transplantation
Drug: Reduced Intensity Conditioning
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by New York Medical College:

Primary Outcome Measures:
  • Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Patients will be followed for one year for adverse events related to the administration of study drug.

  • Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    patients will be assessed for one year to determine survival status


Secondary Outcome Measures:
  • To assess feasibility of developing a bank of LMP-specific CTLs from healthy donors [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: March 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Allogeneic Transplant and Immunotherapy
We 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.
Drug: Brentuximab Vedotin

Brentuximab Vedotin will be administered every 21 days starting on or around Day +42 post allogeneic stem cell transplant for a TOTAL of 4 doses as outlined below:

  • 42 (+/-7 days) Brentuximab Vedotin 1.8 mg/kg (max=180 mg) IV x 1
  • 63 (+/- 7 days) Brentuximab Vedotin 1.8 mg/kg (max=180 mg) IV x 1
  • 84 (+/- 7 days) Brentuximab Vedotin 1.8 mg/kg (max = 180 mg) IV x 1
  • 105 (+/- 7 days) Brentuximab Vedotin 1.8 mg/kg (max=180 mg) IV x 1
Other Name: Adcetris
Procedure: Allogeneic Stem Cell Transplantation
Following conditioning with chemotherapy, patients will receive stem cells from a matched related or unrelated donor.
Drug: Reduced Intensity Conditioning
Patients will receive reduced intensity chemotherapy with one of three regimens: Busulfan/Fludarabine; Gemcitabine/Fludarabine/Melphalan; Fludarabine/Cyclophosphamide

  Eligibility

Ages Eligible for Study:   up to 45 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02098512

Contacts
Contact: Mitchell Cairo, MD 914-594-2150 mitchell_cairo@nymc.edu
Contact: Jessica Hochberg, MD 914-594-2132 jessica_hochberg@nymc.edu

Locations
United States, New York
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Mitchell Cairo    914-594-2150    mitchell_cairo@nymc.edu   
Contact: Jessica Hochberg, MD    914-594-2132    jessica_hochberg@nymc.edu   
Sponsors and Collaborators
New York Medical College
St. Baldrick's Foundation
Investigators
Principal Investigator: Mitchell Cairo, MD New York Medical College
  More Information

Responsible Party: New York Medical College
ClinicalTrials.gov Identifier: NCT02098512     History of Changes
Other Study ID Numbers: NYMC 564 
Study First Received: March 17, 2014
Last Updated: April 29, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by New York Medical College:
Brentuximab Vedotin
Immunotherapy
Relapsed Hodgkin Lymphoma
Refractory Hodgkin Lymphoma
Reduced Intensity Conditioning
Allogeneic Stem Cell Transplantation

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2016