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COG-AALL07P1

Trial

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

June 8, 2009

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

Notes

https://clinicaltrials.gov/ct2/show/NCT00873093

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 Name

Janice Olson, MD

Contact Name

Children's Cancer and Blood Disorders Program

Contact E-Mail

(503) 276-9300

Last Updated: Wednesday, January 27, 2021 11:41:04 AM