Brentuximab Vedotin + Rituximab as Frontline Therapy for Pts w/ CD30+ and/or EBV+ Lymphomas

Conditions

• Adult Grade III Lymphomatoid Granulomatosis
• Adult Nasal Type Extranodal NK/T-cell Lymphoma
• Anaplastic Large Cell Lymphoma
• Angioimmunoblastic T-cell Lymphoma
• Contiguous Stage II Adult Burkitt Lymphoma
• Contiguous Stage II Adult Diffuse Large Cell Lymphoma
• Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma
• Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
• Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma
• Contiguous Stage II Adult Lymphoblastic Lymphoma
• Contiguous Stage II Grade 1 Follicular Lymphoma
• Contiguous Stage II Grade 2 Follicular Lymphoma
• Contiguous Stage II Grade 3 Follicular Lymphoma
• Contiguous Stage II Mantle Cell Lymphoma
• Contiguous Stage II Marginal Zone Lymphoma
• Contiguous Stage II Small Lymphocytic Lymphoma
• Cutaneous B-cell Non-Hodgkin Lymphoma
• Epstein-Barr Virus Infection
• Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
• Hepatosplenic T-cell Lymphoma
• Intraocular Lymphoma
• Nodal Marginal Zone B-cell Lymphoma
• Noncontiguous Stage II Adult Burkitt Lymphoma
• Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
• Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma
• Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
• Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma
• Noncontiguous Stage II Adult Lymphoblastic Lymphoma
• Noncontiguous Stage II Grade 1 Follicular Lymphoma
• Noncontiguous Stage II Grade 2 Follicular Lymphoma
• Noncontiguous Stage II Grade 3 Follicular Lymphoma
• Noncontiguous Stage II Mantle Cell Lymphoma
• Noncontiguous Stage II Marginal Zone Lymphoma
• Noncontiguous Stage II Small Lymphocytic Lymphoma
• Noncutaneous Extranodal Lymphoma
• Peripheral T-cell Lymphoma
• Post-transplant Lymphoproliferative Disorder
• Progressive Hairy Cell Leukemia, Initial Treatment
• Recurrent Adult Burkitt Lymphoma
• Recurrent Adult Diffuse Mixed Cell Lymphoma
• Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
• Recurrent Adult Grade III Lymphomatoid Granulomatosis
• Recurrent Adult Hodgkin Lymphoma
• Recurrent Adult Immunoblastic Large Cell Lymphoma
• Recurrent Adult Lymphoblastic Lymphoma
• Recurrent Adult T-cell Leukemia/Lymphoma
• Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
• Recurrent Grade 1 Follicular Lymphoma
• Recurrent Grade 2 Follicular Lymphoma
• Recurrent Grade 3 Follicular Lymphoma
• Recurrent Mantle Cell Lymphoma
• Recurrent Marginal Zone Lymphoma
• Recurrent Mycosis Fungoides/Sezary Syndrome
• Recurrent Small Lymphocytic Lymphoma
• Refractory Hairy Cell Leukemia
• Small Intestine Lymphoma
• Splenic Marginal Zone Lymphoma
• Stage I Adult Burkitt Lymphoma
• Stage I Adult Diffuse Large Cell Lymphoma
• Stage I Adult Diffuse Mixed Cell Lymphoma
• Stage I Adult Diffuse Small Cleaved Cell Lymphoma
• Stage I Adult Hodgkin Lymphoma
• Stage I Adult Immunoblastic Large Cell Lymphoma
• Stage I Adult Lymphoblastic Lymphoma
• Stage I Adult T-cell Leukemia/Lymphoma
• Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
• Stage I Grade 1 Follicular Lymphoma
• Stage I Grade 2 Follicular Lymphoma
• Stage I Grade 3 Follicular Lymphoma
• Stage I Mantle Cell Lymphoma
• Stage I Marginal Zone Lymphoma
• Stage I Small Lymphocytic Lymphoma
• Stage IA Mycosis Fungoides/Sezary Syndrome
• Stage IB Mycosis Fungoides/Sezary Syndrome
• Stage II Adult Hodgkin Lymphoma
• Stage II Adult T-cell Leukemia/Lymphoma
• Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
• Stage IIA Mycosis Fungoides/Sezary Syndrome
• Stage IIB Mycosis Fungoides/Sezary Syndrome
• Stage III Adult Burkitt Lymphoma
• Stage III Adult Diffuse Large Cell Lymphoma
• Stage III Adult Diffuse Mixed Cell Lymphoma
• Stage III Adult Diffuse Small Cleaved Cell Lymphoma
• Stage III Adult Hodgkin Lymphoma
• Stage III Adult Immunoblastic Large Cell Lymphoma
• Stage III Adult Lymphoblastic Lymphoma
• Stage III Adult T-cell Leukemia/Lymphoma
• Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
• Stage III Grade 1 Follicular Lymphoma
• Stage III Grade 2 Follicular Lymphoma
• Stage III Grade 3 Follicular Lymphoma
• Stage III Mantle Cell Lymphoma
• Stage III Marginal Zone Lymphoma
• Stage III Small Lymphocytic Lymphoma
• Stage IIIA Mycosis Fungoides/Sezary Syndrome
• Stage IIIB Mycosis Fungoides/Sezary Syndrome
• Stage IV Adult Burkitt Lymphoma
• Stage IV Adult Diffuse Large Cell Lymphoma
• Stage IV Adult Diffuse Mixed Cell Lymphoma
• Stage IV Adult Diffuse Small Cleaved Cell Lymphoma
• Stage IV Adult Hodgkin Lymphoma
• Stage IV Adult Immunoblastic Large Cell Lymphoma
• Stage IV Adult Lymphoblastic Lymphoma
• Stage IV Adult T-cell Leukemia/Lymphoma
• Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
• Stage IV Grade 1 Follicular Lymphoma
• Stage IV Grade 2 Follicular Lymphoma
• Stage IV Grade 3 Follicular Lymphoma
• Stage IV Mantle Cell Lymphoma
• Stage IV Marginal Zone Lymphoma
• Stage IV Small Lymphocytic Lymphoma
• Stage IVA Mycosis Fungoides/Sezary Syndrome
• Stage IVB Mycosis Fungoides/Sezary Syndrome
• T-cell Large Granular Lymphocyte Leukemia
• Testicular Lymphoma
• Untreated Hairy Cell Leukemia
• Waldenström Macroglobulinemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• brentuximab vedotin — DRUG
  Given IV
• rituximab — BIOLOGICAL
  Given IV
• laboratory biomarker analysis — OTHER
  Correlative studies

Study Details

The purpose of this study is to evaluate how safe and effective the combination of two different drugs (brentuximab vedotin and rituximab) is in patients with certain types of lymphoma. This study is for patients who have a type of lymphoma that expresses a tumor marker called CD30 and/or a type that is associated with the Epstein-Barr virus (EBV-related lymphoma) and who have not yet received any treatment for their cancer, except for dose-reduction or discontinuation (stoppage) of medications used to prevent rejection of transplanted organs (for those patients who have undergone transplantation). This study is investigating the combination of brentuximab vedotin and rituximab as a first treatment for lymphoma patients

Key Dates

Start date

Mar 5, 2013

Status verified

Aug 2021

Primary completion

Sep 18, 2017

Completion

Dec 31, 2018

Study Design

Enrollment

20 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (brentuximab vedotin, rituximab)
  INDUCTION: Patients receive brentuximab vedotin IV over 30 minutes once weekly for 3 weeks and rituximab IV once weekly for 4 weeks. Patients unable to achieve CR may receive additional optional consolidation therapy identical to induction therapy. MAINTENANCE THERAPY: Patients receive brentuximab vedotin IV once every 3 weeks and rituximab IV once every 6 weeks. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

For Phase I: The Recommended Phase 2 Dose of Brentuximab Vedotin in Combination With Rituximab. [ Time Frame: The first 21 days of Induction ]

Locations (3)

Find similar trials in Chicago, IL

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