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A Phase 1 Study of Brentuximab Vedotin Combined With ABVD for Hodgkin Lymphoma

2014-07-23 21:10:53 | BioPortfolio

Summary

The purpose of this study is to assess the safety profile of brentuximab vedotin in combination with ABVD in treatment-naive Stage IIa or IIb-IV Hodgkin lymphoma. It is a phase 1, single-arm, open-label dose escalation study designed to define the MTD, PK, immunogenicity and anti-tumor activity of brentuximab vedotin in combination with frontline therapy.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Disease, Hodgkin

Intervention

brentuximab vedotin, doxorubicin, vinblastine, dacarbazine, bleomycin

Location

Mayo Clinic Rochester
Rochester
Minnesota
United States
55905

Status

Recruiting

Source

Seattle Genetics, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:10:53-0400

Clinical Trials [1463 Associated Clinical Trials listed on BioPortfolio]

Phase 3 Frontline Therapy Trial in Patients With Advanced Classical Hodgkin Lymphoma

This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin (ADCET...

Doxorubicin Hydrochloride, Vinblastine, Dacarbazine, Brentuximab Vedotin, and Nivolumab in Treating Patients With Stage I-II Hodgkin Lymphoma

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A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma

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Brentuximab Vedotin and Nivolumab in Treating Participants With Early Stage Classic Hodgkin Lymphoma

This phase II trial studies how well brentuximab vedotin and nivolumab work in treating participants with stage I-II classic Hodgkin lymphoma. Monoclonal antibodies, such as brentuximab ve...

A Safety Study of Growth Factor Use in Treatment With Brentuximab Vedotin Plus Chemotherapy

This trial will study a treatment combination for Hodgkin lymphoma. The drugs used in this trial are a targeted anticancer drug (brentuximab vedotin) and three chemotherapy drugs (doxorubi...

PubMed Articles [15007 Associated PubMed Articles listed on BioPortfolio]

Cost-effectiveness of brentuximab vedotin plus chemotherapy as frontline treatment of stage III or IV classical Hodgkin lymphoma.

The ECHELON-1 trial demonstrated efficacy and safety of brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine (A + AVD) versus doxorubicin, bleomycin, vinblastine, and dacarbazine (AB...

Multicenter Phase II Study of Sequential Brentuximab Vedotin and Doxorubicin, Vinblastine, and Dacarbazine Chemotherapy for Older Patients With Untreated Classical Hodgkin Lymphoma.

Purpose To improve the curability of older patients with newly diagnosed Hodgkin lymphoma. Patients and Methods We conducted a multicenter phase II study that administered brentuximab vedotin (Bv) seq...

Provisional Title: Safety Analysis of Brentuximab Vedotin From the Phase 3 AETHERA Trial in Hodgkin Lymphoma in the Posttransplant Consolidation Setting.

The phase 3 AETHERA trial demonstrated brentuximab vedotin's (BV) efficacy as consolidation therapy in patients with classical Hodgkin lymphoma (HL) at high risk of relapse or progression following au...

Brentuximab Vedotin: A Nursing Perspective on Best Practices and Management of Associated Adverse Events.

Brentuximab vedotin (BV) is an antibody-drug conjugate that targets CD30-expressing cells.

Brentuximab vedotin for recurrent Hodgkin lymphoma after allogeneic hematopoietic stem cell transplantation: A report from the EBMT Lymphoma Working Party.

The treatment of patients with Hodgkin lymphoma (HL) who develop disease progression after undergoing allogeneic stem cell transplantation (allo-SCT) remains challenging.

Medical and Biotech [MESH] Definitions

Any of a group of malignant tumors of lymphoid tissue that differ from HODGKIN DISEASE, being more heterogeneous with respect to malignant cell lineage, clinical course, prognosis, and therapy. The only common feature among these tumors is the absence of giant REED-STERNBERG CELLS, a characteristic of Hodgkin's disease.

A complex of related glycopeptide antibiotics from Streptomyces verticillus consisting of bleomycin A2 and B2. It inhibits DNA metabolism and is used as an antineoplastic, especially for solid tumors.

A malignant disease characterized by progressive enlargement of the lymph nodes, spleen, and general lymphoid tissue. In the classical variant, giant usually multinucleate Hodgkin's and REED-STERNBERG CELLS are present; in the nodular lymphocyte predominant variant, lymphocytic and histiocytic cells are seen.

Two or more distinct types of malignant lymphoid tumors occurring within a single organ or tissue at the same time. It may contain different types of non-Hodgkin lymphoma cells or both Hodgkin and non-Hodgkin lymphoma cells.

Clinically benign, histologically malignant, recurrent cutaneous T-cell lymphoproliferative disorder characterized by an infiltration of large atypical cells surrounded by inflammatory cells. The atypical cells resemble REED-STERNBERG CELLS of HODGKIN DISEASE or the malignant cells of CUTANEOUS T-CELL LYMPHOMA. In some cases, lymphomatoid papulosis progresses to lymphomatous conditions including MYCOSIS FUNGOIDES; HODGKIN DISEASE; CUTANEOUS T-CELL LYMPHOMA; or ANAPLASTIC LARGE-CELL LYMPHOMA.

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Relevant Topic

Hodgkin lymphoma
Hodgkin Lymphoma is a  disorder caused by malignant proliferation of lymphocytes, which contain characteristic mirror-image nuclei (Reed-Sternburg cells). The resulting lymphadenopathy can be limited to a single lymph node region (Stage 1) or spread...


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