Research

Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Chemotherapy with Bortezomib – Phase II Pilot

Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Protocol Description

This Children’s Oncology Group Phase II Pilot trial is being done to determine safe dose levels for the drug bortezomib in combination with intensive reinduction chemotherapy in young patients whose lymphoblastic lymphoma (LL), a cancer of the immune system, or acute lymphoblastic leukemia (ALL), a cancer of blood cells, has relapsed. Bortezomib has been approved for use in certain adult blood cancers, but not yet for childhood ALL. This study aims to improve treatment for relapsed ALL, a condition with no generally accepted standard treatment.

Study Level: Phase II Pilot

Eligibility Criteria

Subject to certain exclusion criteria, the study is open to individuals of both genders, from age 1 through 21, who have been diagnosed with ALL and LL that has relapsed or shown to be resistant to conventional therapy.
Males: Ages 1 through 21 years
Females: Ages 1 through 21 years

Requirements
Treatment consists of 3, 5-week blocks of chemotherapy, with a specific dosage of bortezomib given in blocks 1 and 2. Drugs will be administered intravenously in the outpatient clinic. Blood and bone marrow samples will also be collected.
Duration: Approximately 15 weeks with participants followed for about 5 years after the study closes.

Status: Open for Enrollment

Source(s) of Support
Children’s Oncology Group (Study AALL07P1)
National Cancer Institute
Third Party

Additional Resources
Study Description at National Institutes of Health