Phase 1/2 Study of VSLI Plus Rituximab in Patients With Relapsed and/or Refractory NHL

NCT01851551 | Completed Phase 1

• 1 other identifier: CA00005
• Study Type: interventional
• Target: 22
• Locations: 2 countries
• Sites: 2

Brief Summary

This was a Phase 1/2 study performed at two clinical centers in the US and UK. It was a single arm, open label study evaluating VSLI plus rituximab in adults with aggressive relapsed or refractory non-Hodgkin's lymphoma.

Conditions

Non-Hodgkin's Lymphoma; Diffuse Large B-cell Lymphoma; Mantle Cell Lymphoma

Keywords

NHL; non-Hodgkin's lymphoma; diffuse large b-cell lymphoma; mantle cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  The primary efficacy endpoint was the objective response rate (ORR) defined as the proportion of patients whose best responses were complete response (CR) and partial response (PR) (ORR = CR + PR).

  Assessed prior to each cycle for up to 12 cycles (24 weeks). For patients achieving a complete or partial response, follow-up assessments were to be made 2, 8, 16, and 24 weeks after treatment was discontinued (up to ~48 wks).

Secondary Outcomes (3)

• Assessment of the number of events and number and percentage of patients with treatment-emergent AEs

  AEs were assessed up to 30 days post last dose. Dosing may last up to 24 weeks.

• Time to Progression

  First dose to disease progression. Follow up was reported approximately every 3 months post-dose up to the date of patient death. Patients were followed up to 2 yrs.

• Overall survival

  The interval between first dose and death due to any cause. Reported every 3 months post dose up to patient death. Follow up was approximately 2 years

Study Arms (1)

VSLI plus rituximab

EXPERIMENTAL

VSLI (vincristine sulfate liposome injection) plus rituximab

Drug: Vincristine Sulfate Liposome Injection plus rituximab

Interventions

Vincristine Sulfate Liposome Injection plus rituximab DRUG

Also known as: Marqibo, VSLI, rituximab, rituxan

VSLI plus rituximab

Eligibility Criteria

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

You may qualify if:

• Histologically-confirmed diffuse large B-cell non-Hodgkin's lymphoma (NHL), as defined by the Revised European American Lymphoma/WHO classification. This included: diffuse large B-cell, primary mediastinal large B-cell lymphoma with sclerosis,intravascular large B-cell lymphoma, immunoblastic B-cell lymphoma, T-cell rich B-cell lymphoma or anaplastic large B-cell lymphoma. In the US protocol only, patients who had transformation from an indolent lymphoma and those who had mantle cell lymphoma were eligible.
• Confirmation of CD20 expression on lymphoma cells.
• Eastern Cooperative Oncology Group (ECOG) ≤2.
• One or more prior chemotherapy regimens. Patients who had received prior rituximab therapy as part of an induction chemotherapy regimen or who had a previous response to rituximab as a single agent were eligible.
• Measurable disease in at least 1 site, which had not been previously irradiated.
• Measurable disease was defined as at least 1 bidimensionally measurable lesion with clearly defined margins that were ≥1.5 cm in the largest dimension determined by physical examination or computed tomography (CT) scan.
• Total bilirubin and serum creatinine ≤2 times the ULN.
• Absolute neutrophil count (ANC) ≥0.5 × 109/L, and platelets ≥50 × 109/L.
• years of age or older.
• Women of childbearing potential who were willing to use an acceptable method of contraception throughout the course of the study.
• Signed and dated informed consent form.

You may not qualify if:

• Known transformation from an indolent lymphoma (UK protocol only).
• Eligible for conventional or high-dose chemotherapy with curative intent.
• Radiotherapy, chemotherapy, immunotherapy, or corticosteroids (\>10 mg/day of prednisone or equivalent) within the past 4 weeks.
• Any previous malignancies with less than a 5-year complete remission interval, except for curatively resected basal cell carcinoma or curatively resected in situ carcinoma of the uterine cervix.
• History of or active CNS-lymphoma, AIDS-related lymphoma, or any uncontrolled severe medical illness or infection.
• History of neurologic disorders unrelated to chemotherapy (including familial neurologic diseases and acquired demyelinating disorders).
• Grade 3 or 4 sensory or motor neuropathy at screening related to prior chemotherapy.
• Major surgery (excluding that for diagnosis) within 4 weeks of enrollment.
• Pregnant or lactating women (women of childbearing potential underwent a pregnancy test).
• Allergy to vincristine, or other vinca alkaloids.
• Progressive disease while receiving or within 1 month of having received previous rituximab therapy (US protocol only).
• Hypersensitivity to any component of rituximab or to murine proteins (UK protocol only).

Sponsors & Collaborators

• Acrotech Biopharma Inc.: lead

Study Sites (2)

University of California

San Francisco, California, 94110, United States

Location

Leeds General Infirmary

Leeds, West Yorkshire, LS1 3EX, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Mantle-Cell

Interventions

Rituximab; Vincristine

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Lawrence Kaplan, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Gareth Morgan, Prof.

  Leeds General Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 10, 2013
• Study Start: September 1, 2001
• Primary Completion: April 1, 2004
• Study Completion: April 1, 2005
• Last Updated: January 3, 2020

Record last verified: 2019-12

Locations

US (1); GB (1)