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Report for Clinical Trial NCT02518750

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase II Study Incorporating Panobinostat, Bortezomib and Liposomal Vincristine Into Re-Induction Therapy for Relapsed Pediatric T-Cell Acute Lymphoblastic Leukemia or Lymphoma

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.

NCT02518750 Acute Lymphoblastic Leukemia Lymphoma, Non-Hodgkin's Leukemia, T-Cell Leukemia, B-Cell
MeSH:Lymphoma Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Lymphoma, Non-Hodgkin Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Leukemia, B-Cell Leukemia, T-Cell
HPO:Leukemia Lymphoid leukemia Lymphoma Non-Hodgkin lymphoma T-cell acute lymphoblastic leukemias

14 Interventions

Name: Dexamethasone

Description: Given orally (PO).
Type: Drug
Group Labels: 1

Study Participants

Name: Panobinostat

Description: Given PO.
Type: Drug
Group Labels: 1

Study Participants

Name: Liposomal vincristine

Description: For intravenous (IV) use only.
Type: Drug
Group Labels: 1

Study Participants

Name: Mitoxantrone

Description: Given IV.
Type: Drug
Group Labels: 1

Study Participants

Name: Peg-asparaginase

Description: Given IV or intramuscularly (IM). In case of allergy or intolerance to Peg-asparaginase, Erwinia L-asparaginase (Erwinase®) will be used. Erwinia L-asparaginase is given by either IV or IM injection.
Type: Drug
Group Labels: 1

Study Participants

Name: Bortezomib

Description: Given by IV push over 3 to 5 seconds. For IV use only.
Type: Drug
Group Labels: 1

Study Participants

Name: Intrathecal Triples

Description: Given IT as ITMHA.
Type: Drug
Group Labels: 1

Study Participants

Name: High-dose methotrexate

Description: Given intrathecally (IT) or IV.
Type: Drug
Group Labels: 1

Study Participants

Name: 6-Mercaptopurine

Description: Given PO at consistent time each day.
Type: Drug
Group Labels: 1

Study Participants

Name: High-dose cytarabine

Description: Given IT or IV.
Type: Drug
Group Labels: 1

Study Participants

Name: Nelarabine

Description: Given IV
Type: Drug
Group Labels: 1

Study Participants

Name: Cyclophosphamide

Description: Given IV.
Type: Drug
Group Labels: 1

Study Participants

Name: Etoposide

Description: Given IV. In case of etoposide reactions, IV etoposide phosphate (Etopophos®) will be used.
Type: Drug
Group Labels: 1

Study Participants

Name: Clofarabine

Description: Given IV. Clofarabine will be given instead of nelarabine for patients with B-lymphoblastic leukemia and lymphoma in stratum II.
Type: Drug
Group Labels: 1

Study Participants


Primary Outcomes

Description: All participants who start re-induction Block A therapy are considered evaluable. Any patient who at any time point achieves CR and goes to transplant is considered as a success; or any patient who successfully reaches the end of block C and achieves/remains in CR is considered a success; all other cases are considered as failure.

Measure: Complete Remission (CR) Rate

Time: At the end of each remission re-induction block C (approximately 13 weeks after start of therapy)

Secondary Outcomes

Description: MRD will be studied after each cycle of therapy. MRD is considered as positive (i.e., prevalent) if its level is ≥0.01% for ALL. The prevalence of MRD at end of each cycle is defined as proportion of MRD positives; we will estimate these proportions with point and interval estimates.

Measure: Block A Minimal Residual Disease (MRD)

Time: At the end of Block A therapy (approximately 5 weeks after start of therapy)

Description: MRD will be studied after each cycle of therapy. MRD is considered as positive (i.e., prevalent) if its level is ≥0.01% for ALL. The prevalence of MRD at end of each cycle is defined as proportion of MRD positives; we will estimate these proportions with point and interval estimates.

Measure: Block B Minimal Residual Disease (MRD)

Time: At the end of Block B therapy (approximately 10 weeks after start of therapy)

Description: MRD will be studied after each cycle of therapy. MRD is considered as positive (i.e., prevalent) if its level is ≥0.01% for ALL. The prevalence of MRD at end of each cycle is defined as proportion of MRD positives; we will estimate these proportions with point and interval estimates.

Measure: Block C Minimal Residual Disease (MRD)

Time: At the end of Block C therapy (approximately 13 weeks after start of therapy)

Description: The toxicities of liposomal vincristine (VSLI) when used in combination with chemotherapy will be evaluated. Proportions (probabilities) of relevant toxicities will be estimated with point and interval estimates.

Measure: Proportion of Relevant Toxicities

Time: At the completion of therapy (up to approximately 5 months after the start of therapy)

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 Q12H

Additional ITs on Days 10 and 17 for patients with central nervous system (CNS) 2, 3 or traumatic tap with blasts Block B: approximately 5 weeks - High-dose methotrexate 8 g/m^2 IV over 24 hours (will not be given to patients with prior cranial irradiation) Day 1 - 6-mercaptopurine 50 mg/m^2 PO days 1-14 - ITMHA Day 1 - High-dose cytarabine 3 g/m^2 IV every 12 hours (Q12H) Days 15 and 16 Block C: approximately 3 weeks - Nelarabine 650 mg/m^2/day IV Days 1-5 (Clofarabine 40 mg/m^2/day IV Days 1-5 will be given instead of nelarabine for patients with B-lymphoblastic leukemia and lymphoma in stratum II) - Cyclophosphamide 300 mg/m^2 IV Days 1-5 - Etoposide 100 mg/m^2/day IV Days 1-5 Response evaluation is performed after the end of each treatment block. --- Q12H ---



HPO Nodes


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