Protocol

CD22AB: A phase I, multi-center, dose escalation study of CAT-8015 in children, adolescents and young adults with refractory CD22+ acute lymphoblastic leukemia (ALL), or non-Hodgkin’s Lymphoma (NHL) (CAT-8015-1004)

Diseases

Leukemias / Lymphomas : acute lymphoblastic leukemia (ALL), non-Hodgkin’s lymphoma (NHL), including lymphoblastic lymphoma, Burkitt’s lymphoma, and large cell lymphoma

Description

The main purpose of this study is to estimate the maximum tolerated dose (MTD), defined as the highest dose of CAT-8015 that can be safely administered to a patient. This information will be used to recommend the next phase dosage for further pediatric development. The drug CAT-3888, a closely related predecessor compound, has been well tolerated and highly effective in adult patients with lymphoid malignancies.

CAT-8015 is made up of two parts: 1) a modified mouse antibody that combines with a protein from the immune system, called “CD22”, which can also be found on the surface of cancer cells, and 2) a toxin (a type of poison). In laboratory experiments, CAT-8015 has been shown to kill leukemia cells that have the CD22 protein on their surface.

CAT-8015 will be given in "cycles" with each cycle lasting about 3 weeks. How long you stay on this study will depend on the number of treatment cycles that you receive.

Objectives

• To estimate the maximum tolerated dose (MTD), defined as the highest dose that can be safely administered to a patient, and, to establish a safe dose, based on the MTD, for subsequent clinical testing.
• To characterize the tolerability and safety profile.
• To study the clinical pharmacology
• To observe anti-tumor activity of CAT-8015, if any

Eligibility

• Histologically confirmed diagnosis of acute lymphoblastic leukemia (ALL) or non-Hodgkin's lymphoma (NHL) including lymphoblastic lymphoma, Burkitt’s lymphoma, and large cell lymphoma.
• Patients must have relapsed or refractory disease and have received at least one standard chemotherapy and one salvage regimen.
• Evidence of CD22 positive malignancy
• In the view of the PI and the primary oncologist, there must be no available alternative curative therapies and patients must either be ineligible for a hematopoietic stem cell transplant (BMT), have refused BMT, or have disease activity that prohibits the time required to identify a suitable stem cell donor.
• If relapse after allogeneic BMT, the patient must be at least Day 100 post BMT and have no evidence of acute graft vs. host disease
• Must be between the ages of > 6 months and < 25 years
• Adequate organ function and performance status as defined by protocol specifications
• Female and male subjects and their sexual partners, who are of child-bearing potential, must agree to use an approved method of contraception during the study.

Exclusion:

• Any physical, social or psychiatric condition, which in the opinion of the investigator, would prevent effective cooperation or participation in the study.

• For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE  (1-866-278-5833).

Contact

Deepa Bhojwani, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN  38105  USA
Voice: 1-866-2ST-JUDE  (1-866-278-5833)
FAX: 901-521-9005

Referring or consulting physicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.