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

NCT02098512 | Unknown Phase 1 DMC

• 1 other identifier: NYMC 564
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hodgkin Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Safety

  Patients will be followed for one year for adverse events related to the administration of study drug.

  1 year

• Overall Survival

  patients will be assessed for one year to determine survival status

  1 year

Secondary Outcomes (1)

• To assess feasibility of developing a bank of LMP-specific CTLs from healthy donors

  3 years

Study Arms (1)

Allogeneic Transplant and Immunotherapy

EXPERIMENTAL

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; Procedure: Allogeneic Stem Cell Transplantation; Drug: Reduced Intensity Conditioning

Interventions

Brentuximab Vedotin DRUG

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

Also known as: Adcetris

Allogeneic Transplant and Immunotherapy

Allogeneic Stem Cell Transplantation PROCEDURE

Following conditioning with chemotherapy, patients will receive stem cells from a matched related or unrelated donor.

Allogeneic Transplant and Immunotherapy

Reduced Intensity Conditioning DRUG

Patients will receive reduced intensity chemotherapy with one of three regimens: Busulfan/Fludarabine; Gemcitabine/Fludarabine/Melphalan; Fludarabine/Cyclophosphamide

Allogeneic Transplant and Immunotherapy

Eligibility Criteria

• Age: Up to 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York Medical College: lead
• St. Baldrick's Foundation: collaborator

Study Sites (1)

New York Medical College

Valhalla, New York, 10595, United States

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Mitchell Cairo, MD

  New York Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2014
• First Posted: March 28, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2021
• Study Completion: December 31, 2022
• Last Updated: October 27, 2022

Record last verified: 2022-10

Locations

US (1)