Immunotherapy Following Reduced Intensity Conditioning and Allogeneic Stem Cell Transplant for Poor Risk CD30+ Hodgkin Lymphoma Patients
NCT ID: NCT02098512
Last Updated: 2022-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2014-03-01
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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
Allogeneic Stem Cell Transplantation
Following conditioning with chemotherapy, patients will receive stem cells from a matched related or unrelated donor.
Reduced Intensity Conditioning
Patients will receive reduced intensity chemotherapy with one of three regimens: Busulfan/Fludarabine; Gemcitabine/Fludarabine/Melphalan; Fludarabine/Cyclophosphamide
Interventions
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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
Allogeneic Stem Cell Transplantation
Following conditioning with chemotherapy, patients will receive stem cells from a matched related or unrelated donor.
Reduced Intensity Conditioning
Patients will receive reduced intensity chemotherapy with one of three regimens: Busulfan/Fludarabine; Gemcitabine/Fludarabine/Melphalan; Fludarabine/Cyclophosphamide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
45 Years
ALL
Yes
Sponsors
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St. Baldrick's Foundation
OTHER
New York Medical College
OTHER
Responsible Party
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Principal Investigators
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Mitchell Cairo, MD
Role: PRINCIPAL_INVESTIGATOR
New York Medical College
Locations
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New York Medical College
Valhalla, New York, United States
Countries
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Other Identifiers
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NYMC 564
Identifier Type: -
Identifier Source: org_study_id
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