Clinical Trial Title Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Trial Status Closed to Enrollment
Start Date 06/08/2009
Location randall-childrens-hospital-at-legacy-emanuel
Trial Type Pediatric Cancer (Oncology)
Specific Condition Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)
Description A Phase II Pilot Trial of Bortezomib (PS-341, Velcade®, IND# 58,443) in Combination with Intensive Re-Induction Therapy for Children with Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)
Eligibility Criteria Age: >1 and <31 years of age at the time of study enrollment

Pre-B ALL in first early (<36 months from diagnosis) isolated bone marrow or combined bone marrow/extramedullary relapse; OR T-cell ALL in first isolated bone marrow or combined relapse; OR T-LL in first relapse

Patients with leukemia must have had histologic verification of the malignancy at relapse, including immunophenotyping to confirm diagnosis

Patients with lymphoblastic lymphoma must have measurable disease documented by clinical, radiographic, or histologic criteria

Patients must have relapsed or become refractory to conventional therapy

Patients who relapse while received standard ALL maintenance chemotherapy will not be required to have a waiting period before entry onto this study

Patients who relapse on therapy other than standard ALL maintenance therapy must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study

Adequate kidney, liver, heart, and lung functions
IRB Number

Study status is:
Completed: The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Principal Investigator Janice Olson, MD
Contact Name Children's Cancer and Blood Disorders Program
Contact Phone
Contact Fax
Contact E-Mail (503) 276-9300