Study of Rituximab and Brentuximab Vedotin for Relapsed Classical Hodgkin Lymphoma

Johns Hopkins Medicine

Status and phase: Terminated; Phase 1

Conditions: Lymphoma

Treatments: Biological: Brentuximab vedotin; Biological: Rituximab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01900496

J1354

NA_00080336 (Other Identifier)

Details and patient eligibility

About

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

Full description

This research is being done to study a combination of drugs for relapsed Hodgkin's Lymphoma (HL) that may be easier to tolerate than standard therapies and that does not involve an autologous blood or marrow transplant (BMT, also called a stem cell transplant).The study is for people with HL who have never received treatment for relapsed lymphoma, except for radiation therapy. Usually, when HL relapses for the first time, the standard is to receive combinations of chemotherapy, including an autologous blood or marrow transplant (BMT, also called a stem cell transplant) which has about a 40% cure rate. BMT may cure the HL, but also may be associated with serious side effects and risks. This research looks at a combination of drugs for relapsed HL that may not have the side effects of standard therapies and that does not involve BMT. The goal is to treat the lymphoma effectively with drugs that we expect will have fewer side effects, while avoiding a treatment like BMT.

Enrollment: 6 patients

Sex: All

Ages: 16 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

6 participants in 1 patient group

Brentuximab vedotin & Rituximab

Experimental group

Description:

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.

Treatment:

Biological: Brentuximab vedotin

Biological: Rituximab