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Report for Clinical Trial NCT02538926

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase II Study of Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin Plus Asparaginase (DA-EPOCH-A) for Adults With Acute Lymphoblastic Leukemia/Lymphoma

This phase II trial studies how well etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride with asparaginase work in treating patients with acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Asparaginase breaks down the amino acid asparagine and may block the growth of tumor cells that need asparagine to grow. Giving combination chemotherapy with asparaginase may work better in treating patients with acute lymphoblastic leukemia or lymphoblastic lymphoma.

NCT02538926 B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Recurrent Adult Acute Lymphoblastic Leukemia Recurrent B Lymphoblastic Lymphoma Recurrent T Lymphoblastic Leukemia/Lymphoma Refractory B Lymphoblastic Lymphoma Refractory T Lymphoblastic Lymphoma T Acute Lymphoblastic Leukemia T Lymphoblastic Lymphoma
MeSH:Lymphoma Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Lymphoma, Non-Hodgkin Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
HPO:Leukemia Lymphoid leukemia Lymphoma Non-Hodgkin lymphoma T-cell acute lymphoblastic leukemias

9 Interventions

Name: Asparaginase

Description: Given IM or IV
Type: Drug
Group Labels: 1

Treatment (DA-EPOCH-A)

Name: Cyclophosphamide

Description: Given IV
Type: Drug
Group Labels: 1

Treatment (DA-EPOCH-A)

Name: Doxorubicin Hydrochloride

Description: Given IV
Type: Drug
Group Labels: 1

Treatment (DA-EPOCH-A)

Name: Etoposide

Description: Given IV
Type: Drug
Group Labels: 1

Treatment (DA-EPOCH-A)

Name: Imatinib Mesylate

Description: Given PO
Type: Drug
Group Labels: 1

Treatment (DA-EPOCH-A)

Name: Laboratory Biomarker Analysis

Description: Correlative studies
Type: Other
Group Labels: 1

Treatment (DA-EPOCH-A)

Name: Prednisone

Description: Given PO
Type: Drug
Group Labels: 1

Treatment (DA-EPOCH-A)

Name: Rituximab

Description: Given IV
Type: Biological
Group Labels: 1

Treatment (DA-EPOCH-A)

Name: Vincristine Sulfate

Description: Given IV
Type: Drug
Group Labels: 1

Treatment (DA-EPOCH-A)


Primary Outcomes

Description: A Simon two-stage optimum design will be used to define success of this treatment in the two subgroups of patients.

Measure: Complete minimal residual disease response rate

Time: Up to 5 years

Description: A Simon two-stage optimum design will be used to define success of this treatment in the two subgroups of patients.

Measure: Overall response rate (complete response + partial response)

Time: Up to 5 years

Description: A Simon two-stage optimum design will be used to define success of this treatment in the two subgroups of patients.

Measure: Overall survival

Time: From time of initiation of study therapy to up to 5 years

Description: A Simon two-stage optimum design will be used to define success of this treatment in the two subgroups of patients.

Measure: Progression-free survival

Time: From time of initiation of study therapy to up to 5 years

Secondary Outcomes

Measure: Incidence of adverse events, graded using the National Cancer Institute Common Terminology Criteria for Adverse Events

Time: Up to 30 days post-treatment, or until patient receives an alternative anti-cancer therapy, whichever date comes first

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 T315I

Inclusion Criteria: - Patients must have a confirmed diagnosis of either B- or T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma that is either: - Arm A: Initially diagnosed at age 40 or later, OR - Arm B: Relapsed after or failed to respond to >= 1 previous chemotherapy regimen - The regimen under study must constitute a reasonable therapeutic option - Presence of >= 5% abnormal blasts in the bone marrow - Patients with prior allogeneic hematopoietic cell transplantation (HCT) must be at least 90 days post-HCT and must be on =< 20 mg of prednisone (or equivalent dose of an alternative corticosteroid) for treatment/prevention of graft-vs-host disease - Total bilirubin =< 1.5 x institutional upper limit of normal (ULN; unless attributable to Gilbert's disease or other causes of inherited indirect hyperbilirubinemia, at which point total bilirubin must be =< 2.5 x ULN) - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x institutional ULN - Note: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the total bilirubin is =< 3.0 x ULN and ALT/AST are =< 5.0 x ULN - Creatinine =< 1.5 mg/dL; however, patients with a creatinine > 1.5 mg/dL but with a calculated creatinine clearance of > 60 ml/min, as measured by the Modification of Diet in Renal Disease (MDRD) equation, will be eligible - Measurement of left ventricular ejection fraction (LVEF) should be performed in patients with prior anthracycline exposure or known history of arrhythmia or structural heart disease; in these cases, LVEF must be >= 40% - As patients with ALL frequently have cytopenias, no hematologic parameters will be required for enrollment or to receive the first cycle of treatment; however, adequate recovery of blood counts will be required to receive subsequent cycles - Per good clinical practice, any toxicity related to prior therapies that, in the opinion of the investigator, would potentially be worsened with DA-EPOCH-A +/- imatinib (imatinib mesylate) +/- rituximab, should be resolved to grade 1 or less - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 - Women of childbearing potential must have a negative pregnancy test and must agree to the use of effective contraception while on treatment; men must also agree to the use of effective contraception while on treatment - Ability to give informed consent and comply with the protocol - Anticipated survival of at least 3 months Exclusion Criteria: - Patients with Burkitt lymphoma/leukemia - Patients must not have received chemotherapy within 14 days of enrollment, with the two following exceptions: - Routine systemic maintenance therapy (e.g., Abelson murine leukemia viral oncogene homolog 1 [ABL] kinase inhibitor, methotrexate, 6-mercaptopurine, vincristine, etc.) and intrathecal/intraventricular therapy - Systemic therapy for the acute management of hyperleukocytosis or acute symptoms (e.g., corticosteroids, cytarabine, etc.) - May not have prior malignancies unless the expected survival is at least 2 years - For patients with Philadelphia chromosome positive (Ph+) ALL, they must not have progressed within 3 months of receiving imatinib or have a documented ABL kinase mutation known to confer resistance to imatinib (e.g., T315I) - Patients with persistent grade 2 or higher peripheral sensory or motor neuropathy of any cause - Patients with isolated extramedullary disease or with parenchymal central nervous system (CNS) disease - Known hypersensitivity or intolerance to any of the agents under investigation - Human immunodeficiency virus (HIV) positive or evidence of infection with hepatitis B or C virus, as defined by any of the following criteria (if patients have not previously been tested for the following, these will be conducted during screening): - HIV antibody positive - Hepatitis B surface antigen or core antibody positive - Hepatitis C antibody positive - Other medical or psychiatric conditions that in the opinion of the investigator would preclude safe participation in the protocol - May not be pregnant or nursing Inclusion Criteria: - Patients must have a confirmed diagnosis of either B- or T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma that is either: - Arm A: Initially diagnosed at age 40 or later, OR - Arm B: Relapsed after or failed to respond to >= 1 previous chemotherapy regimen - The regimen under study must constitute a reasonable therapeutic option - Presence of >= 5% abnormal blasts in the bone marrow - Patients with prior allogeneic hematopoietic cell transplantation (HCT) must be at least 90 days post-HCT and must be on =< 20 mg of prednisone (or equivalent dose of an alternative corticosteroid) for treatment/prevention of graft-vs-host disease - Total bilirubin =< 1.5 x institutional upper limit of normal (ULN; unless attributable to Gilbert's disease or other causes of inherited indirect hyperbilirubinemia, at which point total bilirubin must be =< 2.5 x ULN) - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x institutional ULN - Note: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the total bilirubin is =< 3.0 x ULN and ALT/AST are =< 5.0 x ULN - Creatinine =< 1.5 mg/dL; however, patients with a creatinine > 1.5 mg/dL but with a calculated creatinine clearance of > 60 ml/min, as measured by the Modification of Diet in Renal Disease (MDRD) equation, will be eligible - Measurement of left ventricular ejection fraction (LVEF) should be performed in patients with prior anthracycline exposure or known history of arrhythmia or structural heart disease; in these cases, LVEF must be >= 40% - As patients with ALL frequently have cytopenias, no hematologic parameters will be required for enrollment or to receive the first cycle of treatment; however, adequate recovery of blood counts will be required to receive subsequent cycles - Per good clinical practice, any toxicity related to prior therapies that, in the opinion of the investigator, would potentially be worsened with DA-EPOCH-A +/- imatinib (imatinib mesylate) +/- rituximab, should be resolved to grade 1 or less - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 - Women of childbearing potential must have a negative pregnancy test and must agree to the use of effective contraception while on treatment; men must also agree to the use of effective contraception while on treatment - Ability to give informed consent and comply with the protocol - Anticipated survival of at least 3 months Exclusion Criteria: - Patients with Burkitt lymphoma/leukemia - Patients must not have received chemotherapy within 14 days of enrollment, with the two following exceptions: - Routine systemic maintenance therapy (e.g., Abelson murine leukemia viral oncogene homolog 1 [ABL] kinase inhibitor, methotrexate, 6-mercaptopurine, vincristine, etc.) and intrathecal/intraventricular therapy - Systemic therapy for the acute management of hyperleukocytosis or acute symptoms (e.g., corticosteroids, cytarabine, etc.) - May not have prior malignancies unless the expected survival is at least 2 years - For patients with Philadelphia chromosome positive (Ph+) ALL, they must not have progressed within 3 months of receiving imatinib or have a documented ABL kinase mutation known to confer resistance to imatinib (e.g., T315I) - Patients with persistent grade 2 or higher peripheral sensory or motor neuropathy of any cause - Patients with isolated extramedullary disease or with parenchymal central nervous system (CNS) disease - Known hypersensitivity or intolerance to any of the agents under investigation - Human immunodeficiency virus (HIV) positive or evidence of infection with hepatitis B or C virus, as defined by any of the following criteria (if patients have not previously been tested for the following, these will be conducted during screening): - HIV antibody positive - Hepatitis B surface antigen or core antibody positive - Hepatitis C antibody positive - Other medical or psychiatric conditions that in the opinion of the investigator would preclude safe participation in the protocol - May not be pregnant or nursing B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Recurrent Adult Acute Lymphoblastic Leukemia Recurrent B Lymphoblastic Lymphoma Recurrent T Lymphoblastic Leukemia/Lymphoma Refractory B Lymphoblastic Lymphoma Refractory T Lymphoblastic Lymphoma T Acute Lymphoblastic Leukemia T Lymphoblastic Lymphoma Lymphoma Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Lymphoma, Non-Hodgkin Precursor T-Cell Lymphoblastic Leukemia-Lymphoma PRIMARY OBJECTIVES: I. To determine the efficacy of dose-adjusted etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride plus asparaginase (DA-EPOCH-A) in adults with acute lymphoblastic leukemia/lymphoma (ALL). --- T315I ---

Inclusion Criteria: - Patients must have a confirmed diagnosis of either B- or T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma that is either: - Arm A: Initially diagnosed at age 40 or later, OR - Arm B: Relapsed after or failed to respond to >= 1 previous chemotherapy regimen - The regimen under study must constitute a reasonable therapeutic option - Presence of >= 5% abnormal blasts in the bone marrow - Patients with prior allogeneic hematopoietic cell transplantation (HCT) must be at least 90 days post-HCT and must be on =< 20 mg of prednisone (or equivalent dose of an alternative corticosteroid) for treatment/prevention of graft-vs-host disease - Total bilirubin =< 1.5 x institutional upper limit of normal (ULN; unless attributable to Gilbert's disease or other causes of inherited indirect hyperbilirubinemia, at which point total bilirubin must be =< 2.5 x ULN) - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x institutional ULN - Note: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the total bilirubin is =< 3.0 x ULN and ALT/AST are =< 5.0 x ULN - Creatinine =< 1.5 mg/dL; however, patients with a creatinine > 1.5 mg/dL but with a calculated creatinine clearance of > 60 ml/min, as measured by the Modification of Diet in Renal Disease (MDRD) equation, will be eligible - Measurement of left ventricular ejection fraction (LVEF) should be performed in patients with prior anthracycline exposure or known history of arrhythmia or structural heart disease; in these cases, LVEF must be >= 40% - As patients with ALL frequently have cytopenias, no hematologic parameters will be required for enrollment or to receive the first cycle of treatment; however, adequate recovery of blood counts will be required to receive subsequent cycles - Per good clinical practice, any toxicity related to prior therapies that, in the opinion of the investigator, would potentially be worsened with DA-EPOCH-A +/- imatinib (imatinib mesylate) +/- rituximab, should be resolved to grade 1 or less - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 - Women of childbearing potential must have a negative pregnancy test and must agree to the use of effective contraception while on treatment; men must also agree to the use of effective contraception while on treatment - Ability to give informed consent and comply with the protocol - Anticipated survival of at least 3 months Exclusion Criteria: - Patients with Burkitt lymphoma/leukemia - Patients must not have received chemotherapy within 14 days of enrollment, with the two following exceptions: - Routine systemic maintenance therapy (e.g., Abelson murine leukemia viral oncogene homolog 1 [ABL] kinase inhibitor, methotrexate, 6-mercaptopurine, vincristine, etc.) and intrathecal/intraventricular therapy - Systemic therapy for the acute management of hyperleukocytosis or acute symptoms (e.g., corticosteroids, cytarabine, etc.) - May not have prior malignancies unless the expected survival is at least 2 years - For patients with Philadelphia chromosome positive (Ph+) ALL, they must not have progressed within 3 months of receiving imatinib or have a documented ABL kinase mutation known to confer resistance to imatinib (e.g., T315I) - Patients with persistent grade 2 or higher peripheral sensory or motor neuropathy of any cause - Patients with isolated extramedullary disease or with parenchymal central nervous system (CNS) disease - Known hypersensitivity or intolerance to any of the agents under investigation - Human immunodeficiency virus (HIV) positive or evidence of infection with hepatitis B or C virus, as defined by any of the following criteria (if patients have not previously been tested for the following, these will be conducted during screening): - HIV antibody positive - Hepatitis B surface antigen or core antibody positive - Hepatitis C antibody positive - Other medical or psychiatric conditions that in the opinion of the investigator would preclude safe participation in the protocol - May not be pregnant or nursing Inclusion Criteria: - Patients must have a confirmed diagnosis of either B- or T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma that is either: - Arm A: Initially diagnosed at age 40 or later, OR - Arm B: Relapsed after or failed to respond to >= 1 previous chemotherapy regimen - The regimen under study must constitute a reasonable therapeutic option - Presence of >= 5% abnormal blasts in the bone marrow - Patients with prior allogeneic hematopoietic cell transplantation (HCT) must be at least 90 days post-HCT and must be on =< 20 mg of prednisone (or equivalent dose of an alternative corticosteroid) for treatment/prevention of graft-vs-host disease - Total bilirubin =< 1.5 x institutional upper limit of normal (ULN; unless attributable to Gilbert's disease or other causes of inherited indirect hyperbilirubinemia, at which point total bilirubin must be =< 2.5 x ULN) - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x institutional ULN - Note: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the total bilirubin is =< 3.0 x ULN and ALT/AST are =< 5.0 x ULN - Creatinine =< 1.5 mg/dL; however, patients with a creatinine > 1.5 mg/dL but with a calculated creatinine clearance of > 60 ml/min, as measured by the Modification of Diet in Renal Disease (MDRD) equation, will be eligible - Measurement of left ventricular ejection fraction (LVEF) should be performed in patients with prior anthracycline exposure or known history of arrhythmia or structural heart disease; in these cases, LVEF must be >= 40% - As patients with ALL frequently have cytopenias, no hematologic parameters will be required for enrollment or to receive the first cycle of treatment; however, adequate recovery of blood counts will be required to receive subsequent cycles - Per good clinical practice, any toxicity related to prior therapies that, in the opinion of the investigator, would potentially be worsened with DA-EPOCH-A +/- imatinib (imatinib mesylate) +/- rituximab, should be resolved to grade 1 or less - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 - Women of childbearing potential must have a negative pregnancy test and must agree to the use of effective contraception while on treatment; men must also agree to the use of effective contraception while on treatment - Ability to give informed consent and comply with the protocol - Anticipated survival of at least 3 months Exclusion Criteria: - Patients with Burkitt lymphoma/leukemia - Patients must not have received chemotherapy within 14 days of enrollment, with the two following exceptions: - Routine systemic maintenance therapy (e.g., Abelson murine leukemia viral oncogene homolog 1 [ABL] kinase inhibitor, methotrexate, 6-mercaptopurine, vincristine, etc.) and intrathecal/intraventricular therapy - Systemic therapy for the acute management of hyperleukocytosis or acute symptoms (e.g., corticosteroids, cytarabine, etc.) - May not have prior malignancies unless the expected survival is at least 2 years - For patients with Philadelphia chromosome positive (Ph+) ALL, they must not have progressed within 3 months of receiving imatinib or have a documented ABL kinase mutation known to confer resistance to imatinib (e.g., T315I) - Patients with persistent grade 2 or higher peripheral sensory or motor neuropathy of any cause - Patients with isolated extramedullary disease or with parenchymal central nervous system (CNS) disease - Known hypersensitivity or intolerance to any of the agents under investigation - Human immunodeficiency virus (HIV) positive or evidence of infection with hepatitis B or C virus, as defined by any of the following criteria (if patients have not previously been tested for the following, these will be conducted during screening): - HIV antibody positive - Hepatitis B surface antigen or core antibody positive - Hepatitis C antibody positive - Other medical or psychiatric conditions that in the opinion of the investigator would preclude safe participation in the protocol - May not be pregnant or nursing B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Recurrent Adult Acute Lymphoblastic Leukemia Recurrent B Lymphoblastic Lymphoma Recurrent T Lymphoblastic Leukemia/Lymphoma Refractory B Lymphoblastic Lymphoma Refractory T Lymphoblastic Lymphoma T Acute Lymphoblastic Leukemia T Lymphoblastic Lymphoma Lymphoma Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Lymphoma, Non-Hodgkin Precursor T-Cell Lymphoblastic Leukemia-Lymphoma PRIMARY OBJECTIVES: I. To determine the efficacy of dose-adjusted etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride plus asparaginase (DA-EPOCH-A) in adults with acute lymphoblastic leukemia/lymphoma (ALL). --- T315I --- --- T315I ---



HPO Nodes


HPO: