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NCT Number: NCT00532259

CT-011 MAb in DLBCL Patients Following ASCT

Autologous peripheral blood stem cell transplantation combined with high dose chemotherapy is the treatment of choice given to patients with diffuse large-B cell lymphoma (DLBCL) following relapse of the disease. Although many people are cured of their lymphoma with this therapy, the disease comes back in a certain proportion of patients. The purpose of this study is to test the safety and effectiveness of the monoclonal antibody, CT-011, in patients with DLBCL who have received autologous peripheral blood stem cell transplantation. All final eligible patients will receive an IV infusion of CT-011 on Day 1 (30 to 90 days post autologous PBSCT). Treatment will be repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85. Follow-up for safety and clinical outcome will be conducted throughout the study till 18 months post autologous PBSCT. Approximately 70 patients will participate in this study.

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Key information

Conditions

Lymphoma, Large Cell, Diffuse Disease Attributes Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Mixed Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Mediastinal Large B-Cell Lymphoma Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jaslok Hospital and Research Centre, Mumbai, Maharashtra, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient's age is 18 years or older, both genders.
  • Confirmed Diffuse Large B-cell Lymphoma, transformed follicular lymphoma, diffuse mixed cell lymphoma or primary mediastinal large cell lymphoma with B-cell lineage.
  • The lymphoma is chemosensitive.
  • The lymphoma did not progress since pre-transplant chemotherapy.
  • ECOG performance status 0-1.

Exclusion criteria

  • Serious other illness.
  • Active autoimmune disease.
  • Type 1 diabetes.
  • Known immune deficiency.
  • Clinical evidence of primary or secondary brain or spinal cord involvement by lymphoma.
  • Active bacterial, fungal, or viral infection.
  • Positive HIV, Hepatitis B surface antigen plus viremia, or Hepatitis C antibody plus viremia.
  • Pregnant or nursing (positive pregnancy test).
  • Other concurrent clinical study or investigational therapy.

Treatment and study plan

CT-011

Drug

IV infusion of 1.5 mg/kg of CT-011 on Day 1(60 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.

Other names: Pidilizumab

Primary outcomes

  1. Progression-free Survival

    Time frame: 16 months following the first CT-011 administration (approximately 18 months following autologous PBSCT).

    PFS (progression-free survival ) will be determined at the eligible patient populations

Secondary outcomes

  1. Overall Survival

    Time frame: within 16 months following the first CT-011 treatment (18 months following autologous PBSCT).

Sponsors and collaborators

Lead sponsor

CureTech Ltd

Industry

Registry information

Official study title

Phase II Safety and Efficacy Study of the Monoclonal Antibody CT-011 in Patients With Diffuse Large B-Cell Lymphoma Following Autologous Stem Cell Transplantation

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Sep 20, 2007
Registry last updated
Sep 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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