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

Primary Purpose

Hodgkin Lymphoma

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Brentuximab Vedotin

Allogeneic Stem Cell Transplantation

Reduced Intensity Conditioning

About this trial

This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring Brentuximab Vedotin, Immunotherapy, Relapsed Hodgkin Lymphoma, Refractory Hodgkin Lymphoma, Reduced Intensity Conditioning, Allogeneic Stem Cell Transplantation

Eligibility Criteria

undefined - 45 Years (Child, Adult)All SexesAccepts 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.

Sites / Locations

New York Medical College

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Allogeneic Transplant and Immunotherapy

Arm 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.

Outcomes

Primary Outcome Measures

Safety

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

Overall Survival

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

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.

Full Information

NCT ID

NCT02098512

First Posted

March 17, 2014

Last Updated

October 24, 2022

Sponsor

New York Medical College

Collaborators

St. Baldrick's Foundation

1. Study Identification

Unique Protocol Identification Number

NCT02098512

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 1, 2014 (Actual)

Primary Completion Date

December 1, 2021 (Actual)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

New York Medical College

Collaborators

St. Baldrick's Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hodgkin Lymphoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Allogeneic Transplant and Immunotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Brentuximab Vedotin

Other Intervention Name(s)

Adcetris

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Allogeneic Stem Cell Transplantation

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Reduced Intensity Conditioning

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety

Description

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

Time Frame

1 year

Title

Overall Survival

Description

patients will be assessed for one year to determine survival status

Time Frame

1 year

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

3 years

10. Eligibility

Sex

All

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mitchell Cairo, MD

Organizational Affiliation

New York Medical College

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York Medical College

City

Valhalla

State/Province

New York

ZIP/Postal Code

10595

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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