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

Launched by BRISTOL-MYERS SQUIBB · Mar 1, 2006

Keywords

ClinConnect 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 diseas...

Gender

ALL

Eligibility criteria

• 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.