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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02098512
Recruitment Status : Unknown
Verified March 2019 by New York Medical College.
Recruitment status was:  Recruiting
First Posted : March 28, 2014
Last Update Posted : March 13, 2019
St. Baldrick's Foundation
Information provided by (Responsible Party):
New York Medical College

Brief Summary:
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 or disease Intervention/treatment Phase
Hodgkin Lymphoma Drug: Brentuximab Vedotin Procedure: Allogeneic Stem Cell Transplantation Drug: Reduced Intensity Conditioning Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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)
Actual Study Start Date : March 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

  2. Overall Survival [ Time Frame: 1 year ]
    patients will be assessed for one year to determine survival status

Secondary Outcome Measures :
  1. To assess feasibility of developing a bank of LMP-specific CTLs from healthy donors [ Time Frame: 3 years ]
    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.

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Ages Eligible for Study:   up to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02098512

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Contact: Mitchell Cairo, MD 914-594-2150
Contact: Jessica Hochberg, MD 914-594-2132

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United States, New York
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Mitchell Cairo    914-594-2150   
Contact: Jessica Hochberg, MD    914-594-2132   
Sponsors and Collaborators
New York Medical College
St. Baldrick's Foundation
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Principal Investigator: Mitchell Cairo, MD New York Medical College
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Responsible Party: New York Medical College Identifier: NCT02098512    
Other Study ID Numbers: NYMC 564
First Posted: March 28, 2014    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Keywords provided by New York Medical College:
Brentuximab Vedotin
Relapsed Hodgkin Lymphoma
Refractory Hodgkin Lymphoma
Reduced Intensity Conditioning
Allogeneic Stem Cell Transplantation
Additional relevant MeSH terms:
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Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases