Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma
Summary
The overall objective of this protocol is to improve the cure rate of relapsed precursor B-cell acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma. This phase II trial is studying risk-directed therapy for B-lymphoblastic leukemia or lymphoma in first relapse. Standard risk (SR) and high risk (HR) participants will receive different therapy. Treatment will consist of chemotherapy for SR participants, and chemotherapy followed by hematopoietic stem cell transplant (HSCT) for HR in first relapse. Induction therapy consists of three blocks of chemotherapy. The first block is a novel immunotherapy regimen that includes chemotherapy, rituximab and infusion of haploidentical natural killer (NK) cells. SR participants will continue to receive chemotherapy for a total duration of approximately 2 years. HR participants will be candidates for HSCT and will proceed to transplant once a suitable donor is found and their minimal residual disease (MRD) is negative.
Timeline
- Start
- 2013-04-15
- Primary completion
- 2021-07-24
- Completion
- 2021-07-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Clofarabine | Other / unclassified | — | Intravenous |
| Comparator | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Comparator | Cytarabine | Small molecule | — | Intrathecal |
| Comparator | Dexamethasone | Small molecule | — | Intravenous |
| Comparator | Etoposide | Small molecule | — | Intravenous |
| Comparator | MERCAPTOPURINE ANHYDROUS | Small molecule | — | Oral |
| Comparator | Methotrexate | Small molecule | — | Intrathecal |
| Comparator | Mitoxantrone | Small molecule | — | Intravenous |
| Comparator | Pegaspargase | Protein / enzyme biologic | — | Intravenous |
| Comparator | Rituximab | Monoclonal antibody | — | Intravenous |
| Comparator | Teniposide | Small molecule | — | Intravenous |
| Comparator | Vinblastine | Small molecule | — | Intravenous |
| Comparator | Vincristine | Small molecule | — | Intravenous |
| Comparator | aldesleukin | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | natural killer cell infusion | Cell therapy | — | — |
| Comparator | Hydrocortisone | Other / unclassified | — | Intrathecal |