Clinical trial NCT02653989: Efficacy and Safety Study of MDV9300 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Lymphoma, Large B-Cell, Diffuse
Primary Mediastinal Large B-cell Lymphoma
Transformed Indolent Lymphoma
Lead sponsor: Medivation, Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Best overall response rate
timeFrame: no later than 6 months after the last patient is enrolled in a cohort
Secondary outcomes:
measure: Duration of response (for responders)
timeFrame: no later than 6 months after the last patient is enrolled in a cohort
measure: Progression-free survival
timeFrame: no later than 6 months after the last patient is enrolled in a cohort
measure: Time to response (for responders)
timeFrame: no later than 6 months after the last patient is enrolled in a cohort
measure: Overall survival
timeFrame: no later than 6 months after the last patient is enrolled in a cohort
measure: Composite of safety
timeFrame: no later than 6 months after the last patient is enrolled in a cohort
Other outcomes:
Locations:
city: Nashville
country: United States
state: Tennessee
Study officials:
References: