COG-AALL07P1
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 | |
Notes | https://clinicaltrials.gov/ct2/show/NCT00873093 Study status is: |
Principal Investigator | Janice Olson, MD |
Contact Name | Children's Cancer and Blood Disorders Program |
Contact Phone | |
Contact Fax | |
Contact E-Mail | (503) 276-9300 |