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
12 Years
N/A
Both
Lymphoma, Large-Cell
Trial Information
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
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective response rate
Authority:
United States: Food and Drug Administration
Study ID:
MDX060-04
NCT ID:
NCT00298467
Start Date:
February 2006
Completion Date:
Related Keywords:
- Lymphoma, Large-Cell
- ALCL
- csALCL
- pcALCL
- Lymphoma
- Non-Hodgkin's Lymphoma
- Anaplastic Large Cell Lymphoma
- classic systemci Anaplastic Large Cell Lymphoma (csALCL)
- primary cutaneous Anaplastic Large Cell Lymphoma (pcALCL)
- Lymphoma
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Non-Hodgkin
- Lymphoma, Large-Cell, Anaplastic
- Lymphoma, Primary Cutaneous Anaplastic Large Cell
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
| Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
| Roswell Park Cancer Center | Buffalo, New York 14263 |
| California Oncology of the Central Valley | Fresno, California 93710 |
| Carolina BioOncology Institute | Huntersville, North Carolina 28078 |
| City of Hope, National Medical Center | Duarte, California 91010 |
| The Cancer Institute of New Jersey - Robert Wood Johnson Unv. Hosp. | New Brunswick, New Jersey 08901 |
