Efficacy and Safety Study of MDV9300 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Lymphoma, Large B-Cell, Diffuse Clinical Trial

Official title:

An International, Phase 2, Open-Label, Efficacy and Safety Study of MDV9300 in Patients With an Incomplete Response Following Salvage Therapy or Autologous Stem Cell Transplantation for Relapsed or Refractory CD20+ Diffuse Large B-Cell Lymphoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02653989
• Other study ID #: MDV9300-01
• Status: Withdrawn
• Phase: Phase 2
• First received: January 11, 2016
• Last updated: November 22, 2016
• Start date: December 2016
• Est. completion date: August 2018

Study information

• Verified date: November 2016
• Source: Medivation, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of MDV9300 in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that have achieved either stable disease or a partial remission following definitive salvage therapy.

Two cohorts of patients will be enrolled: a cohort treated with salvage chemotherapy but considered ineligible for autologous stem cell transplant (ASCT), and a cohort of patients who have received ASCT following salvage chemotherapy.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older and willing and able to provide informed consent;

• Histologically confirmed relapsed or refractory CD20+ DLBCL, transformed indolent lymphoma (follicular or other), or primary mediastinal large B-cell lymphoma;

• Received prior treatment with a standard anthracycline and therapeutic anti-CD20 monoclonal antibody-based regimen;

• For transplant-ineligible patients, salvage therapy just prior to MDV9300 treatment must have resulted in a PR or stable disease;

• For post autologous stem cell transplant (ASCT) patients, salvage therapy plus ASCT just prior to MDV9300 treatment must have resulted in a PR or stable disease;

• Adequate bone marrow reserve as defined per protocol;

• Eastern Cooperative Oncology Group (ECOG) performance status = 1. Patients with stable ECOG scores of 2 may be allowed with medical monitor approval.

Exclusion Criteria:

• Burkitt, mantle cell, follicular, or mucosa-associated lymphoid tissue lymphoma

• History of serious autoimmune disease;

• History of central nervous system involvement of lymphoma;

• Prior therapy with agents targeting immune coinhibitory receptors.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Primary Mediastinal Large B-cell Lymphoma
• Transformed Indolent Lymphoma

Intervention

Biological:
• MDV9300
MDV9300 will be administered at a dose of 200 mg by intravenous (IV) infusion every 2 weeks until treatment discontinuation criteria are met.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medivation, Inc.	Medivation is now a wholly owned subsidiary of Pfizer Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best overall response rate	Defined as the proportion of patients in the intent-to-treat population with a complete response (CR) or partial response (PR) attributable to study treatment, as assessed by the independent review committee (IRC).	no later than 6 months after the last patient is enrolled in a cohort	No
Secondary	Duration of response (for responders)	Defined as the time from the first objective evidence of CR or PR as assessed by the IRC to the first objective evidence of disease progression or death due to any cause, whichever occurs first.	no later than 6 months after the last patient is enrolled in a cohort	No
Secondary	Progression-free survival	Defined as the time from the date of first study drug infusion to the first objective evidence of disease progression or death due to any cause, whichever occurs first.	no later than 6 months after the last patient is enrolled in a cohort	No
Secondary	Time to response (for responders)	Defined as the time from the date of first study drug infusion to the first objective evidence of CR or PR as assessed by the IRC.	no later than 6 months after the last patient is enrolled in a cohort	No
Secondary	Overall survival	Defined as the time from the date of first study drug infusion to death due to any cause.	no later than 6 months after the last patient is enrolled in a cohort	No
Secondary	Composite of safety	Safety will be evaluated by incidence and severity of adverse events, including serious adverse events and incidence of permanent treatment discontinuation due to adverse events.	no later than 6 months after the last patient is enrolled in a cohort	Yes