Re-Induction Therapy for Relapsed Pediatric T-Cell Acute Lymphoblastic Leukemia or Lymphoma
Status:
Terminated
Trial end date:
2018-03-11
Target enrollment:
Participant gender:
Summary
This is a phase-II study to evaluate the efficacy of a salvage regimen in children with
relapsed T-cell ALL or lymphoma. Peg-asparaginase, mitoxantrone, intrathecal triples (IT)
(intrathecal methotrexate/hydrocortisone/cytarabine) (ITMHA) and dexamethasone are commonly
used drugs to treat relapsed or refractory acute lymphocytic leukemia or lymphoma (ALL). In
this study, the investigators want to know if adding three drugs called panobinostat,
bortezomib and liposomal vincristine (VSLI) to this regimen will result in remission (no
signs or symptoms of leukemia or lymphoma).
- Panobinostat has been approved by the FDA for treating adults with multiple myeloma, but
it has not been approved for use in children and has not been given together with the
other drugs used in this study. It has not been widely studied in children.
- VSLI has been approved by the FDA for adults with relapsed or refractory ALL, but has
not yet been approved for treating children with leukemia or lymphoma.
- Bortezomib has been approved by the FDA for treating adults with a cancer called
multiple myeloma and adults with relapsed mantle cell lymphoma; it has not been approved
for treating children.
PRIMARY OBJECTIVE:
- To estimate the complete remission (CR) rate for patients with T-cell lymphoblastic
leukemia and lymphoma in first relapse.
SECONDARY OBJECTIVES:
- To evaluate minimal residual disease (MRD) levels at end of each block of therapy.
- To describe the toxicities of vincristine sulfate liposome injection (VSLI) when used in
combination with chemotherapy and bortezomib.