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

Phase 1

Active, not recruiting

• Conditions: Hodgkin Lymphoma
• Interventions: Drug: Brentuximab Vedotin; Procedure: Allogeneic Stem Cell Transplantation; Drug: Reduced Intensity Conditioning

• Registration Number: NCT02098512
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-01
• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-03-24
• Study First Posted: 2014-03-28
• Primary Completion: 2021-12-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-27
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Allogeneic Transplant and Immunotherapy	Allogeneic Stem Cell Transplantation	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.
Allogeneic Transplant and Immunotherapy	Reduced Intensity Conditioning	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.
Allogeneic Transplant and Immunotherapy	Brentuximab Vedotin	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.

Primary Outcome Measures

Name	Time	Method
Overall Survival	1 year	patients will be assessed for one year to determine survival status
Safety	1 year	Patients will be followed for one year for adverse events related to the administration of study drug.

Secondary Outcome Measures

Name	Time	Method
To assess feasibility of developing a bank of LMP-specific CTLs from healthy donors	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.

Trial Locations

Locations (1)

New York Medical College; 🇺🇸 Valhalla, New York, United States