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

New York Medical College

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Hodgkin Lymphoma

Treatments: Procedure: Allogeneic Stem Cell Transplantation; Drug: Reduced Intensity Conditioning; Drug: Brentuximab Vedotin

Study type: Interventional

Funder types: Other

Identifiers

NCT02098512

NYMC 564

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: Under 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Allogeneic Transplant and Immunotherapy

Experimental group

Description:

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.

Treatment:

Procedure: Allogeneic Stem Cell Transplantation

Drug: Brentuximab Vedotin

Drug: Reduced Intensity Conditioning