Study Stopped
sponsor decision
MDX-060 in Patients With Relapsed or Refractory Classic Systemic or Primary Cutaneous Anaplastic Large Cell Lymphoma
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
1 other identifier
interventional
45
2 countries
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 1, 2006
CompletedFirst Posted
Study publicly available on registry
March 2, 2006
CompletedApril 26, 2010
April 1, 2010
March 1, 2006
April 23, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Objective response rate
progression free survival
response duration
Quality of Life
Immunogenicity
best objective response rate
safety
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
City of Hope, National Medical Center
Duarte, California, 91010, United States
California Oncology of the Central Valley
Fresno, California, 93710, United States
Moores UCSD Cancer Center
La Jolla, California, 92093, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
The Cancer Institute of New Jersey - Robert Wood Johnson Unv. Hosp.
New Brunswick, New Jersey, 08901, United States
Roswell Park Cancer Center
Buffalo, New York, 14263, United States
Carolina BioOncology Institute
Huntersville, North Carolina, 28078, United States
Centre Hospitalier Regional Unv. de Lille, Hopital Claude Huriez
Lille, 59037, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 1, 2006
First Posted
March 2, 2006
Study Start
February 1, 2006
Last Updated
April 26, 2010
Record last verified: 2010-04