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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00924 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2560.00 | Other Identifier | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
| P30CA015704 | U.S. NIH Grant/Contract | View source | |
| P01CA018029 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Seagen Inc. | INDUSTRY |
| National Cancer Institute (NCI) | NIH |
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This phase I/II trial studies the side effects and best way to give brentuximab vedotin and to see how well it works after donor stem cell transplant in treating patients with hematologic malignancies. Monoclonal antibodies, such as brentuximab vedotin, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Monoclonal antibodies may kill cancer cells that are left after donor stem cell transplant.
PRIMARY OBJECTIVES:
I. To determine the incidence of durable donor hematopoietic engraftment (defined by donor T-cell chimerism > 50% at day +84 after hematopoietic cell transplantation [HCT]) after allogeneic HCT and post-transplant brentuximab vedotin.
SECONDARY OBJECTIVES:
I. Rates of complete and partial response; incidence of acute graft-versus-host disease (GVHD) grades II-IV and chronic GVHD; overall and progression-free survival; rates of serious adverse events associated with brentuximab vedotin.
OUTLINE:
Patients receive brentuximab vedotin intravenously (IV) on day 1. Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (brentuximab vedotin) | Experimental | Patients receive brentuximab vedotin IV on day 1. Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brentuximab vedotin | Drug | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of durable hematopoietic engraftment defined as the achievement of > 50% donor CD3+ cell chimerism | Evaluated according to the allogeneic transplant protocol on which patients are co-enrolled, or according to institutional standard practice if no monitoring scheme is specified in the transplant protocol. | At day 84 after HCT |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of relapse | Response criteria will be based on the 2007 revisions to the International Working Group criteria for malignant lymphoma. | Up to 5 years |
| Non-relapse mortality | Response criteria will be based on the 2007 revisions to the International Working Group criteria for malignant lymphoma. |
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Inclusion Criteria:
Patients must have a cluster of differentiation (CD)30+ malignancy, with CD30 positivity demonstrated either at time of original diagnosis or at any subsequent time point
Patients must have undergone allogeneic HCT from a related or unrelated donor; acceptable donors include:
Patients must have documented post-transplant donor CD3+ chimerism of > 50% in sorted peripheral-blood CD3+ cells
Patients must be at least 28 days out from allogeneic HCT at the time of enrollment; in general, patients should be no more than 60 days out from allogeneic HCT at time of enrollment; however, patients more than 60 days out from allogeneic HCT may be considered for enrollment in discussion with the protocol investigator (Dr. Maloney)
Patients must be enrolled on an FHCRC non-myeloablative allogeneic transplant protocol (not standard treatment plan); for eligibility purposes, "non-myeloablative" is defined here as conditioning therapy consisting of =< 4 Gy total body irradiation, with or without fludarabine
Patients with prior exposure to brentuximab vedotin are eligible for enrollment on this trial, regardless of previous disease response
Women of childbearing age and men with female partners of childbearing age must be willing and able to use an effective method of contraception during the study and for at least 30 days after the last study dose of brentuximab vedotin
Patients must be able to give informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Maloney | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| laboratory biomarker analysis | Other | Correlative studies |
|
| pharmacological study | Other | Correlative studies |
|
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| Up to 5 years |
| Incidence of acute GVHD | Up to 5 years |
| Peak grade of acute GVHD | Up to 5 years |
| Incidence of chronic GVHD | Up to 5 years |
| Severity of chronic GVHD | Up to 5 years |
| Incidence of adverse events related to brentuximab vedotin, graded according to National Cancer Institute Common Toxicity Criteria version 4 | Up to 30 days after completion of study treatment |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000079963 | Brentuximab Vedotin |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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