Phase 2 Completed N=72 Treatment

CT-011 MAb in DLBCL Patients Following ASCT

Non-Hodgkin's Lymphoma

Source: ClinicalTrials.gov NCT00532259 ↗

Enrolled (actual)

Serious AEs

31.9%

Results posted

Sep 2014

Primary outcomePrimary: Progression-free Survival — 72 Percent

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression-free Survival	72	—
SECONDARY Overall Survival	85	—

Eligibility Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT00532259). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.