Study of Rituximab and Brentuximab Vedotin for Relapsed Classical Hodgkin Lymphoma

NCT01900496 | Terminated Phase 1 DMC

• 2 other identifiers: J1354NA_00080336
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done to study a combination of Brentuximab vedotin and Rituximab for the treatment of relapsed Hodgkin's Lymphoma (HL).

Conditions

Lymphoma

Keywords

cHL; Hodgkin lymphoma; Lymphoma; relapsed Lymphoma; SGN-35; Brentuximab Vedotin; Rituxan; Rituximab

Outcome Measures

Primary Outcomes (1)

• Failure-free survival

  Percentage of participants alive without any of the following: death, disease progression or relapse, or failure to achieve complete remission as defined by the Cheson criteria. Per Cheson Criteria: Complete Response (CR) is disappearance of all evidence of disease; Partial Response (PR) is regression of measurable disease and no new sites (≥50% decrease in sum of product diameters of up to 6 largest dominant masses and splenic/liver nodules), and no increase in size of other nodes/liver/spleen; reduction in target lesions, no growth of non-target or new lesions; Progression is any new lesion or increase by ≥50% of previously involved sites from the nadir

  Up to 7 months

Secondary Outcomes (6)

• Safety of combination of brentuximab vedotin and rituximab in relapsed classical Hodgkin's Lymphoma

  Up to 7 months

• Survival

  Up to 7 months

• Response rate

  Up to 7 months

• Time to best response

  Up to 7 months

• Duration of response

  Up to 7 months

Study Arms (1)

Brentuximab vedotin & Rituximab

EXPERIMENTAL

Brentuximab vedotin: Will be administered at 1.8 mg/kg IV over 30 minutes is given for up to 10 doses (cycles), with a cycle length of 21 days. Brentuximab vedotin is first given on day 1 of cycles 1, 2, 3, and 4 as a single agent (weeks 0, 3, 6, and 9, respectively). Four cycles are chosen because of the 12-week median time to CR in the pivotal phase 2 trial of brentuximab vedotin after autologous BMT for HL. Brentuximab vedotin will be administered with Rituximab at 375 mg/m2 IV is given for up to 8 "induction" doses: day 1 of week 6, 7, 8, and 9; day 1 of week 12, 15, 18 and 21. This is followed by rituximab "maintenance" (375 mg/m2 IV once every 3 months x 2 doses) to complete a \~ 1 year total course of therapy.

Biological: Brentuximab vedotin; Biological: Rituximab

Interventions

Brentuximab vedotin BIOLOGICAL

Day 1 every three weeks (weeks 0, 3, 6, 9, ... 27): 1.8 mg/kg IV. Ten doses maximum.

Also known as: SGN-35, Adcetris

Brentuximab vedotin & Rituximab

Rituximab BIOLOGICAL

Day 1 of weeks 12, 13, 14, 15, 18, 21, 24, and 27: 375 mg/m\^2 IV. Additional doses are given at three and six months post week 27.

Also known as: Rituxan

Brentuximab vedotin & Rituximab

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 16 years
• Biopsy-proven diagnosis of classical Hodgkin Lymphoma (regardless of HRS cell CD20 expression) per the World Health Organization classification criteria24; lymphocyte predominant histology is excluded
• Untreated relapse of classical Hodgkin Lymphoma (with the exception of steroids) as follows:HL that relapsed \> 3 months after completion of first-line chemotherapy or combined modality therapy, and has not yet been treated with salvage chemotherapy, Stage I-II HL that relapsed \> 3 months after first-line chemotherapy, then relapsed after radiation therapy delivered with curative intent, and has not yet been treated with salvage chemotherapy
• Radiographically measurable disease (\> 1 focus of lymphoma measuring \> 1.5 cm)
• Baseline laboratories: ANC \> 1000/uL and platelets \> 75,000/uL, unless due to bone marrow involvement by lymphoma, Serum creatinine \< 2.0 mg/dL, Total bilirubin \< 2.0 mg/dL (excluding Gilbert's syndrome), unless due to lymphoma
• ECOG performance status 0, 1 or 2.

You may not qualify if:

• Active concurrent malignancy with the exception of superficial non-melanoma skin cancer and cervical carcinoma in situ.
• Primary induction failure, defined as failure to achieve CR with first-line chemotherapy or chemoradiation, disease progression during first-line chemotherapy or chemoradiation, or progression or biopsy-proven disease persistence within 8 weeks of first-line therapy completion
• Prior brentuximab vedotin or rituximab for lymphoma
• Grade \> 2 peripheral neuropathy
• HIV infection, active hepatitis B infection, or active hepatitis C infection

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Genentech, Inc.: collaborator

Study Sites (1)

The Sidney Kimmel Comprehensive Canceer Center

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Brentuximab Vedotin; Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Murine-Derived

Study Officials

• Nina Wagner-Johnston, MD

  The Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: July 16, 2013
• Study Start: June 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 17, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)