MDX-060 in Patients With Relapsed or Refractory Classic Systemic or Primary Cutaneous Anaplastic Large Cell Lymphoma

Lymphoma, Large-Cell Clinical Trial

Official title:

An Open-label, Fixed-dose, Multicenter, Phase II Study of MDX-060 in Patients With Relapsed or Refractory Classic Systemic or Primary Cutaneous Anaplastic Large Cell Lymphoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00298467
• Other study ID #: MDX060-04
• Status: Withdrawn
• Phase: Phase 2
• First received: March 1, 2006
• Last updated: April 23, 2010
• Start date: February 2006

Study information

• Verified date: April 2010
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is an open-label, fixed-dose, multicenter study of MDX-060 in patients with ALCL who have relapsed or refractory disease. There will be 3 phases of this study: Induction, Maintenance, and Follow-up. Patients will be required to attend all protocol-required visits in the 4-week Induction Phase, in which administration of MDX-060 will occur, as well as other testing. Patients who complete the Induction Phase may be eligible for additional MDX-060 treatment ever 2 months for 1 year in the Maintenance Phase. Patients who complete the Maintenance Phase with a response of stable disease or better will be followed every 2 months for 1 year or until disease progression. The purpose of this study is to determine objective response rate at Day 50 in patients with relapsed or refractory classic systemic ALCL or primary cutaneous ALCL treated with MDX-060. Other objectives will be evaluated.

Description:

This study is an open-label, fixed-dose, multicenter study of MDX-060 in patients with ALCL who have relapsed or refractory disease. There will be 3 phases of this study: Induction, Maintenance, and Follow-up. Patients will be required to attend all protocol-required visits in the 4-week Induction Phase, in which administration of MDX-060 will occur, as well as other testing. Patients who complete the Induction Phase may be eligible for additional MDX-060 treatment ever 2 months for 1 year in the Maintenance Phase. Patients who complete the Maintenance Phase with a response of stable disease or better will be followed every 2 months for 1 year or until disease progression.

The primary objective of the study is to determine the objective response rate (ORR) at Day 50 in patients with relapsed or refractory classic systemic anaplastic large cell lymphoma (csALCL) or primary cutaneous ALCL (pcALCL) treated with MDX-060. The ORR will be based on an adaption of the NCI Response Criteria for Non-Hodgkin's Lymphoma (NHL) for patients with csALCL and will be based on the Physician's Global Assessment (PGA) for patient with pcALCL.

Secondary objectives include 1) characterizing progression-free survival (PFS); 2) determining response duration (RD); 3) characterizing the effect of MDX-060 on health-related Quality of Life (QoL); 4) evaluating patients with pcALCL using an adaption of the NCI Response Criteria for NHL; 5) characterizing the immunogenicity of MDX-060; 6) characterizing the safety of MDX-060; and 7) determining the best objective response rate (BORR) during the Maintenance Phase of the study.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 45
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• signed informed consent

• confirmed diagnosis of ALCL

• patient with csALCL must be confirmed CD30+

• patients with csALCL must have failed or relapsed following second line (i.e. salvage) chemotherapy or relapsed or failed following autologous stem cell transplant.

• patients with pcALCL must have progressed after treatment with local radiation therapy or surgical excision or failed systemic therapy with a single agent or multi-agent regimen.

• patients with pcALCL must be confirmed CD30+

• ECOG performance of 0 to 2

• at least 12 years of age

• life expectancy 12 weeks or greater

• must meet screening laboratory values

• women must be post-menopausal for at least 1 year; surgically incapable of bearing children; or utilizing a reliable form of contraception. All women must have a negative pregnancy test.

• men must agree to the use of male contraception for the duration of the study

• patients on corticosteroids must be tapered off the medication 2 weeks prior to the first MDX-060 administration and remain off corticosteroids until day 365.

Exclusion Criteria:

• previous treatment with any anti-CD30 antibody

• history of allogenic transplantation

• any tumor lesion 10 cm or greater in diameter

• any other malignancy, excluding basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ. Any cancer from which the patient has been disease free for at least 5 years is permissible.

• any significant acter or chronic infection.

• prior known serum positivity for HIV, hepatitis B or C as determined at screening.

• treatment with an investigational agent within 30 days or 5 half-lives (whichever is longer) of study screening.

• apparent active or latent tuberculosis infection (TB).

• patients who are pregnant or nursing

• any underlying medical condition which, in the investigator's opinion, will make the administration of MDX-060 hazardous or obscure the interpretation of adverse events.

• concomitant chemotherapy, corticosteroids, investigational agents, other anti-ALCL biologics, or radiation therapy

• patients with mycosis fungoides, or

• patients with recurrent, self-healing papulonodular eruptions only or any other lymphoma other than ALCL.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Large-Cell
• Lymphoma, Large-Cell, Anaplastic
• Lymphoma, Non-Hodgkin
• Lymphoma, Primary Cutaneous Anaplastic Large Cell

Intervention

Drug:
• MDX-060

Locations

Country	Name	City	State
France	Centre Hospitalier Regional Unv. de Lille, Hopital Claude Huriez	Lille
United States	Roswell Park Cancer Center	Buffalo	New York
United States	City of Hope, National Medical Center	Duarte	California
United States	California Oncology of the Central Valley	Fresno	California
United States	Carolina BioOncology Institute	Huntersville	North Carolina
United States	Moores UCSD Cancer Center	La Jolla	California
United States	The Cancer Institute of New Jersey - Robert Wood Johnson Unv. Hosp.	New Brunswick	New Jersey
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate
Primary	progression free survival
Primary	response duration
Primary	Quality of Life
Primary	Immunogenicity
Primary	best objective response rate
Primary	safety

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm