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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-01158 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| EA9152 | Other Identifier | ECOG-ACRIN Cancer Research Group | |
| EA9152 | Other Identifier | CTEP | |
| U10CA180820 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase Ib/II trial studies the side effects and best dose of venetoclax and how well it works when given together with vincristine in treating patients with T-cell or B-cell acute lymphoblastic leukemia that has come back (recurrent) or does not respond to treatment (refractory). Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as vincristine, 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. Giving venetoclax together with vincristine may work better in treating patients with acute lymphoblastic leukemia compared to vincristine alone.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose of venetoclax in combination with vincristine liposomal (liposomal vincristine)/vincristine sulfate in patients with relapsed or refractory T-cell and B-cell acute lymphoblastic leukemia (ALL). (Phase I) II. Safety assessment and toxicity characterization after treatment of venetoclax in combination with liposomal vincristine in patients with relapsed or refractory T-cell and B-cell ALL. (Phase I) III. To determine the preliminary efficacy of venetoclax in combination with liposomal vincristine/vincristine sulfate to induce complete remission (CR)+ incomplete complete remission (CRi) in patients with relapsed or refractory T-cell and B-cell ALL. (Phase II)
SECONDARY OBJECTIVES:
I. To determine the progression free survival, overall survival and toxicity after the combination treatment in patients with relapsed or refractory T-cell and B-cell ALL. (Phase II) II. To determine the rate of minimal residual disease (MRD) negativity rate of the combination. (Phase II)
EXPLORATORY/CORRELATIVE OBJECTIVES:
I. To determine if genetic signature as determined by next generation sequencing can predict response to combination. (Phase II) II. To determine if immunophenotype of ALL is associated with response to combination. (Phase II) III. To determine if the BH3 profile is associated with response to combination. (Phase II) IV. To determine if relative expression of BCL-2 measure by flow cytometry is associated with response to combination. (Phase II)
OUTLINE: This is a phase Ib, dose-escalation study of venetoclax followed by a phase II study.
PHASE Ib: Patients receive venetoclax orally (PO) once daily (QD) on days 1-42 of cycle 1 and days 43-70 of cycle 2. Patients also receive vincristine liposomal intravenously (IV) over 1 hour weekly for 4 weeks starting on day 15 of cycle 1. Patients who achieve at least a stable disease response may continue treating at the discretion of the treating physician in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the trial. Patients may also undergo computed tomography (CT) and/or positron emission tomography (PET) scan as well as a lumbar puncture as clinically indicated.
PHASE II: Patients receive venetoclax PO QD on days 1-28 of each cycle. Patients also receive vincristine liposomal IV over 1 hour weekly for 4 weeks on day 1 of each cycle or vincristine sulfate IV weekly on days 1, 8, 15, and 22 of cycle 1 and once every 4 weeks on day 1 of each subsequent cycle. Cycles repeat every 28 days. Patients who achieve at least a stable disease response may continue treating at the discretion of the treating physician in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the trial. Patients may also undergo CT and/or PET scan as well as a lumbar puncture as clinically indicated.
After completion of study treatment, patients are followed up every 6 months for 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase Ib (venetoclax, vincristine liposomal) | Experimental | Patients receive venetoclax PO QD on days 1-42 of cycle 1 and days 43-70 of cycle 2. Patients also receive vincristine liposomal IV over 1 hour weekly for 4 weeks starting on day 15 of cycle 1. Patients who achieve at least a stable disease response may continue treating at the discretion of the treating physician in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the trial. Patients may also undergo CT and/or PET scan as well as a lumbar puncture as clinically indicated. |
|
| Phase II (venetoclax, vincristine liposomal/sulfate) | Experimental | Patients receive venetoclax PO QD on days 1-28 of each cycle. Patients also receive vincristine liposomal IV over 1 hour weekly for 4 weeks on day 1 of each cycle or vincristine sulfate IV weekly on days 1, 8, 15, and 22 of cycle 1 and once every 4 weeks on day 1 of each subsequent cycle. Cycles repeat every 28 days. Patients who achieve at least a stable disease response may continue treating at the discretion of the treating physician in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the trial. Patients may also undergo CT and/or PET scan as well as a lumbar puncture as clinically indicated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo blood sample collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicity (Phase I) | A dose limiting toxicity (DLT) was defined by the occurrence of any protocol-listed toxicities (CTCAE version 5.0 criteria) possibly, probably, or definitely related to study medication or combination within the first cycle (i.e., ≤ 42 days of first dose of study drug). The phase I portion of this study will use a standard 3+3 design. Escalation would continue until > 33% of a particular dose arm experiences a DLT. The next lower dose arm would be considered the MTD. If < two (2) patients experience a DLT in Arm C, then the Arm C dose would be considered the MTD. | From start of treatment up to 42 days |
| Number of Participants With Treatment-Related Toxicities (Phase I) | Toxicities will be assessed and graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 6 years and 11 months |
| Complete Remission (CR) + Complete Remission Incomplete (CRi) Rate (Phase II) | CR+CRi rate (for the best overall response) by the end of cycle 3. A 90% confidence interval will be computed. Tumor response was determined by patient's bone marrow samples that were locally analyzed according to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Acute Lymphoblastic Leukemia; 2019 [updated May 15 2019]. Available from: https://www.nccn.org/professionals/physician\_gls/pdf/all.pdf. | Assessed at baseline, then every cycle, up to the end of cycle 3 (1 cycle = 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) (Phase II) | From study registration to documented disease progression or death from any cause, whichever occurs first. PFS will be estimated using the Kaplan-Meier method, and the median PFS along with its corresponding 95% confidence interval will be reported. Progressive disease is defined as a 50% increase in blasts in the marrow. Tumor response was determined by patient's bone marrow samples that were locally analyzed according to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Acute Lymphoblastic Leukemia; 2019 [updated May 15 2019]. Available from: https://www.nccn.org/professionals/physician\_gls/pdf/all.pdf. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intracellular BCL-2 Expression (Phase II) | Will be assessed by flow cytometry and dichotomized into two groups by the median (low versus [vs] high). Univariate Cox proportional hazards (PH) models will be used to evaluate the association of the BCL-2 expression at baseline and immunophenotype (B-cell and T-cell acute lymphoblastic leukemia) with OS and PFS, separately. Logistic regression models will be used to investigate the association of the BCL-2 expression at baseline and immunophenotype with response (CR/CRi/partial remission [PR] vs others by 70 days). Multivariable Cox PH modelling and logistic regression modelling will also be used to adjust for the effect of covariates that are possibly associated with these efficacy outcomes. |
Inclusion Criteria:
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 0: Patient must be considered a potential candidate for the trial
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients must have a diagnosis of:
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Age >= 18 years
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Eastern Cooperative Oncology Group (ECOG) performance status 0-2
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Adequate liver function with aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than 3 x upper limit of normal and total bilirubin less than 2 mg/dL within 10 days prior to first dose of study agent
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Circulating white blood cell (WBC) count must not be above 25 x 10^9/L at the time of registration
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Glomerular filtration rate (GFR) of at least 40 mL/min within 7 days prior to first dose of study agent
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: All patients of childbearing potential must have a blood test or urine study with a minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin (HCG) within 2 weeks prior to registration to rule out pregnancy
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients must not expect to conceive or father children by using accepted and highly effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 30 days after the last dose of venetoclax
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: No evidence of prior solid malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma, or any surgically- or radiation-cured malignancy continuously disease free for >= 2 years so as not to interfere with interpretation of radiographic response
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients may be enrolled with a prior allogeneic hematopoietic stem cell transplant (HSCT) but the transplant date must be at least 90 days before date of registration to step 1; patient must be off immunosuppression and without active graft versus host disease (GVHD) prior to registration to step 1 if previous HSCT
ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 0: Patient must be considered a potential candidate for the trial
ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Relapsed or refractory B-cell or T-cell ALL, including lymphoblastic lymphoma, after at least one line of chemotherapy
ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Age >= 18 years
ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: ECOG performance status 0-2
ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Adequate liver function with AST/ALT less than 3 x upper limit of normal and total bilirubin less than 2 mg/dL within 10 days prior to first dose of study agent
ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Circulating WBC count must not be above 25 x 10^9/L at the time of registration to step 1
ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: GFR of at least 40 mL/min within 7 days prior to first dose of study agent
ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: All patients of childbearing potential must have a blood test or urine study with a minimum sensitivity 25 IU/L or equivalent units of HCG within 2 weeks prior to registration to rule out pregnancy.
ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients must not expect to conceive or father children by using accepted and highly effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 30 days after the last dose of venetoclax
ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients may be enrolled with a prior allogeneic hematopoietic stem cell transplant (HSCT) but the transplant date must be at least 90 days before date of enrollment; patient must be off immunosuppression and without active GVHD prior to enrollment if previous HSCT. Low-dose steroids (10mg or less) are allowed
Exclusion Criteria:
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients of childbearing potential must not be pregnant or breast-feeding due to risk of fetal harm by the chemotherapeutic agents prescribed in this protocol
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients with isolated testicular or central nervous system (CNS) relapsed disease are not eligible
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients must not have Burkitt's lymphoma/leukemia based on the World Health Organization (WHO) criteria
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients must not have active central nervous system (CNS) leukemia, as defined by unequivocal morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF) or the use of CNS-directed local treatment for active disease within the prior 28 days; prophylactic intrathecal chemotherapy is allowed; previously treated CNS disease with documented clearance of the CSF will be allowed
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients will not be enrolled if they received prior chemotherapy within 2 weeks before registration to step 1 with the following exceptions: to reduce the circulating lymphoblast count or palliation or for ALL maintenance (mercaptopurine, methotrexate, vincristine, thioguanine, and/or tyrosine kinase inhibitors)
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients cannot have poorly controlled chronic viral infections including hepatitis B, C, or human immunodeficiency virus (HIV); HIV positive patients are allowed on this study if they have a CD4 count >= 400, and are on a stable antiviral regimen
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients with New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia may not be enrolled
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients with serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolled
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients must not be taking any other experimental medications within 21 days prior to registration. Clinical trial medications that are Food and Drug Administration (FDA) approved will be allowed within 14 days prior to registration
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients should not have received the following within 7 days prior to the first dose of study drug:
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients must not have grade 3 or higher peripheral neuropathy or history of grade 3 or higher peripheral neuropathy. Patients with familial demyelinating disease like Charcot-Marie-Tooth disease are also excluded
ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients with prior venetoclax treatment for ALL will be excluded
ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients must not be pregnant or breast-feeding due to risk of fetal harm by the chemotherapeutic agents prescribed in this protocol
ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical or breast carcinoma, or chemotherapy-surgically- or radiation-cured malignancy continuously disease free for >= 2 years
ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients with isolated testicular or CNS relapsed disease are not eligible
ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients must not have Burkitt's lymphoma/leukemia based on the WHO criteria
ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients must not have active central nervous system (CNS) leukemia, as defined by unequivocal morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF) or the use of CNS-directed local treatment for active disease within the prior 28 days; prophylactic intrathecal chemotherapy is allowed; previously treated CNS disease with documented clearance of the CSF will be allowed and once cleared, prophylactic intrathecal chemotherapy can be continued
ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patient will not be enrolled if they received prior chemotherapy within 2 weeks before enrollment with the following exceptions: to reduce the circulating lymphoblast count or palliation (i.e., steroids or hydroxyurea), for ALL maintenance (mercaptopurine, methotrexate, vincristine, thioguanine, and/or tyrosine kinase inhibitors)
ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients cannot have poorly controlled chronic viral infections including hepatitis B, C, or HIV; HIV positive patients with undetectable viral load are allowed
ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients with NYHA class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia may not be enrolled
ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients with serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolled
ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration
ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients must not have received the following within 7 days prior to the first dose of study drug or while on study treatment:
ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients must not have grade 3 or higher peripheral neuropathy or history of grade 3 peripheral neuropathy; patients with familial demyelinating diseases like Charcot-Marie-Tooth disease also excluded
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| Name | Affiliation | Role |
|---|---|---|
| Neil D Palmisiano | ECOG-ACRIN Cancer Research Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anchorage Associates in Radiation Medicine | Anchorage | Alaska | 98508 | United States | ||
| Anchorage Radiation Therapy Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39415930 | Result | Palmisiano ND, Lee JW, Claxton DF, Paietta EM, Alkhateeb H, Park J, Podoltsev NA, Atallah EL, Schaar DG, Dinner SN, Webster JA, Luger SM, Litzow MR. A phase 1 trial of venetoclax in combination with liposomal vincristine in patients with relapsed or refractory B-cell or T-cell acute lymphoblastic leukemia: Results from the ECOG-ACRIN EA9152 protocol. EJHaem. 2024 Aug 8;5(5):951-956. doi: 10.1002/jha2.991. eCollection 2024 Oct. | |
| Result | Neil Palmisiano, Juwhei Lee, David Claxton, Elisabeth Paietta, Nikolai Podoltsev, Jae Park, Dale Schaar, Jonathan Webster, Selina Luger, Mark Litzow; Phase II Results of ECOG-ACRIN EA9152: A multicenter study of liposomal vincristine (L-VCR) or vincristine sulfate (VCR) and venetoclax (VEN) in relapsed or refractory acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LL). Blood 2025; 146 (Supplement 1): 1577. doi: https://doi.org/10.1182/blood-2025-1577 |
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Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.
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Phase I treatment employed a standard 3 + 3 dose escalation design, starting at dose level 1. The phase II portion of this trial was a single arm, open-label study.
Phase I Arm A (Dose Level 1) enrollment: 3
Phase I Arm B (Dose Level 2) enrollment: 12
Phase I Arm C (Dose Level 3) enrollment: 3
Phase II enrollment: 22
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase Ib Arm A (Dose Level 1) | Dose Level 1: venetoclax 20, 50, 100, 200 mg on Days 1, 2, 3, 4 and 400 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2022 |
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| Computed Tomography | Procedure | Undergo CT scan |
|
|
| Lumbar Puncture | Procedure | Undergo lumbar puncture |
|
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| Positron Emission Tomography | Procedure | Undergo PET scan |
|
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| Venetoclax | Drug | Given PO |
|
|
| Vincristine Liposomal | Drug | Given IV |
|
|
| Vincristine Sulfate | Drug | Given IV |
|
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| While on treatment and every 6 months during follow-up if discontinued for reasons other than PD, up to 5 years from study registration |
| Overall Survival (OS) (Phase II) | From study registration to death from any cause. OS will be estimated using the Kaplan-Meier method, and the median OS along with its corresponding 95% confidence interval will be reported. | While on treatment and every 6 months during follow-up, up to 5 years from study registration |
| Incidence of Toxicities (Phase II) | Toxicity incidences will be assessed and graded according to the CTCAE and will be tabulated by patient cohort. | Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years |
| Minimal Residual Disease (MRD) Negativity Rate (Phase II) | The MRD response reported here was based on the local assessment (i.e., by site) and met the criteria per protocol: "An MRD negative response must meet the criteria for CR or CRi and have any residual disease <0.01% based on original testing technique." | Assessed at baseline, then every cycle, up to the end of cycle 3 (1 cycle = 28 days) |
| Baseline up to 5 years |
| Immunophenotype of Acute Lymphoblastic Leukemia (Phase II) | Logistic regression models will be used to investigate the association of the BCL-2 expression at baseline and immunophenotype with response (CR/CRi/PR vs. others by 70 days). Multivariable Cox PH modelling and logistic regression modelling will also be used to adjust for the effect of covariates that are possibly associated with these efficacy outcomes. | Up to 5 years |
| Genetic Signature (Phase II) | Will be assessed by next generation sequencing. | Up to 5 years |
| BH3 Profile (Phase II) | Will determine if the BH3 profile is associated with response to combination. | Up to 5 years |
| Expression of BCL-2 (Phase II) | Will determine if relative expression of BCL-2 measure by flow cytometry is associated with response to combination. | Up to 5 years |
| Anchorage |
| Alaska |
| 99504 |
| United States |
| Alaska Breast Care and Surgery LLC | Anchorage | Alaska | 99508 | United States |
| Alaska Oncology and Hematology LLC | Anchorage | Alaska | 99508 | United States |
| Alaska Women's Cancer Care | Anchorage | Alaska | 99508 | United States |
| Anchorage Oncology Centre | Anchorage | Alaska | 99508 | United States |
| Katmai Oncology Group | Anchorage | Alaska | 99508 | United States |
| Providence Alaska Medical Center | Anchorage | Alaska | 99508 | United States |
| Mayo Clinic Hospital in Arizona | Phoenix | Arizona | 85054 | United States |
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
| Mercy Hospital Fort Smith | Fort Smith | Arkansas | 72903 | United States |
| CARTI Cancer Center | Little Rock | Arkansas | 72205 | United States |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California | 91505 | United States |
| Smilow Cancer Hospital Care Center at Saint Francis | Hartford | Connecticut | 06105 | United States |
| Smilow Cancer Center/Yale-New Haven Hospital | New Haven | Connecticut | 06510 | United States |
| Yale University | New Haven | Connecticut | 06520 | United States |
| University of Florida Health Science Center - Jacksonville | Jacksonville | Florida | 32209 | United States |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | United States |
| Saint Luke's Cancer Institute - Boise | Boise | Idaho | 83712 | United States |
| Saint Luke's Cancer Institute - Fruitland | Fruitland | Idaho | 83619 | United States |
| Saint Luke's Cancer Institute - Meridian | Meridian | Idaho | 83642 | United States |
| Saint Luke's Cancer Institute - Nampa | Nampa | Idaho | 83686 | United States |
| Saint Luke's Cancer Institute - Twin Falls | Twin Falls | Idaho | 83301 | United States |
| Saint Anthony's Health | Alton | Illinois | 62002 | United States |
| Illinois CancerCare-Bloomington | Bloomington | Illinois | 61704 | United States |
| Loyola Center for Health at Burr Ridge | Burr Ridge | Illinois | 60527 | United States |
| Illinois CancerCare-Canton | Canton | Illinois | 61520 | United States |
| Memorial Hospital of Carbondale | Carbondale | Illinois | 62902 | United States |
| SIH Cancer Institute | Carterville | Illinois | 62918 | United States |
| Illinois CancerCare-Carthage | Carthage | Illinois | 62321 | United States |
| Centralia Oncology Clinic | Centralia | Illinois | 62801 | United States |
| Saint Mary's Hospital | Centralia | Illinois | 62801 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| John H Stroger Jr Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois | 62526 | United States |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | United States |
| Illinois CancerCare-Dixon | Dixon | Illinois | 61021 | United States |
| Crossroads Cancer Center | Effingham | Illinois | 62401 | United States |
| Illinois CancerCare-Eureka | Eureka | Illinois | 61530 | United States |
| Illinois CancerCare-Galesburg | Galesburg | Illinois | 61401 | United States |
| Western Illinois Cancer Treatment Center | Galesburg | Illinois | 61401 | United States |
| Loyola Medicine Homer Glen | Homer Glen | Illinois | 60491 | United States |
| Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois | 61443 | United States |
| Illinois CancerCare-Macomb | Macomb | Illinois | 61455 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Marjorie Weinberg Cancer Center at Loyola-Gottlieb | Melrose Park | Illinois | 60160 | United States |
| Good Samaritan Regional Health Center | Mount Vernon | Illinois | 62864 | United States |
| Cancer Care Center of O'Fallon | O'Fallon | Illinois | 62269 | United States |
| HSHS Saint Elizabeth's Hospital | O'Fallon | Illinois | 62269 | United States |
| Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois | 61350 | United States |
| Illinois CancerCare-Pekin | Pekin | Illinois | 61554 | United States |
| OSF Saint Francis Radiation Oncology at Pekin | Pekin | Illinois | 61554 | United States |
| Illinois CancerCare-Peoria | Peoria | Illinois | 61615 | United States |
| OSF Saint Francis Radiation Oncology at Peoria Cancer Center | Peoria | Illinois | 61615 | United States |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | United States |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | United States |
| Illinois CancerCare-Peru | Peru | Illinois | 61354 | United States |
| Valley Radiation Oncology | Peru | Illinois | 61354 | United States |
| Illinois CancerCare-Princeton | Princeton | Illinois | 61356 | United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | United States |
| Springfield Clinic | Springfield | Illinois | 62702 | United States |
| Memorial Medical Center | Springfield | Illinois | 62781 | United States |
| Illinois CancerCare - Washington | Washington | Illinois | 61571 | United States |
| Central Care Cancer Center - Garden City | Garden City | Kansas | 67846 | United States |
| Central Care Cancer Center - Great Bend | Great Bend | Kansas | 67530 | United States |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | United States |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | United States |
| Minnesota Oncology - Burnsville | Burnsville | Minnesota | 55337 | United States |
| Cambridge Medical Center | Cambridge | Minnesota | 55008 | United States |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Unity Hospital | Fridley | Minnesota | 55432 | United States |
| Fairview Clinics and Surgery Center Maple Grove | Maple Grove | Minnesota | 55369 | United States |
| Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota | 55109 | United States |
| Saint John's Hospital - Healtheast | Maplewood | Minnesota | 55109 | United States |
| Abbott-Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| Health Partners Inc | Minneapolis | Minnesota | 55454 | United States |
| Monticello Cancer Center | Monticello | Minnesota | 55362 | United States |
| New Ulm Medical Center | New Ulm | Minnesota | 56073 | United States |
| Fairview Northland Medical Center | Princeton | Minnesota | 55371 | United States |
| North Memorial Medical Health Center | Robbinsdale | Minnesota | 55422 | United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | 55416 | United States |
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| United Hospital | Saint Paul | Minnesota | 55102 | United States |
| Saint Francis Regional Medical Center | Shakopee | Minnesota | 55379 | United States |
| Lakeview Hospital | Stillwater | Minnesota | 55082 | United States |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | United States |
| Rice Memorial Hospital | Willmar | Minnesota | 56201 | United States |
| Minnesota Oncology Hematology PA-Woodbury | Woodbury | Minnesota | 55125 | United States |
| Fairview Lakes Medical Center | Wyoming | Minnesota | 55092 | United States |
| Saint Louis Cancer and Breast Institute-Ballwin | Ballwin | Missouri | 63011 | United States |
| Central Care Cancer Center - Bolivar | Bolivar | Missouri | 65613 | United States |
| Cox Cancer Center Branson | Branson | Missouri | 65616 | United States |
| Saint Francis Medical Center | Cape Girardeau | Missouri | 63703 | United States |
| Southeast Cancer Center | Cape Girardeau | Missouri | 63703 | United States |
| Parkland Health Center - Farmington | Farmington | Missouri | 63640 | United States |
| MU Health Care Goldschmidt Cancer Center | Jefferson City | Missouri | 65109 | United States |
| Freeman Health System | Joplin | Missouri | 64804 | United States |
| Mercy Hospital Joplin | Joplin | Missouri | 64804 | United States |
| Lake Regional Hospital | Osage Beach | Missouri | 65065 | United States |
| Delbert Day Cancer Institute at PCRMC | Rolla | Missouri | 65401 | United States |
| Mercy Clinic-Rolla-Cancer and Hematology | Rolla | Missouri | 65401 | United States |
| Heartland Regional Medical Center | Saint Joseph | Missouri | 64506 | United States |
| Sainte Genevieve County Memorial Hospital | Sainte Genevieve | Missouri | 63670 | United States |
| Mercy Hospital Springfield | Springfield | Missouri | 65804 | United States |
| CoxHealth South Hospital | Springfield | Missouri | 65807 | United States |
| Saint Louis Cancer and Breast Institute-South City | St Louis | Missouri | 63109 | United States |
| Mercy Hospital South | St Louis | Missouri | 63128 | United States |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | United States |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | United States |
| Missouri Baptist Sullivan Hospital | Sullivan | Missouri | 63080 | United States |
| BJC Outpatient Center at Sunset Hills | Sunset Hills | Missouri | 63127 | United States |
| Mercy Hospital Washington | Washington | Missouri | 63090 | United States |
| Saint Patrick Hospital - Community Hospital | Missoula | Montana | 59802 | United States |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | United States |
| Monmouth Medical Center | Long Branch | New Jersey | 07740 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| Community Medical Center | Toms River | New Jersey | 08755 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Mercy Hospital Oklahoma City | Oklahoma City | Oklahoma | 73120 | United States |
| Saint Charles Health System | Bend | Oregon | 97701 | United States |
| Clackamas Radiation Oncology Center | Clackamas | Oregon | 97015 | United States |
| Providence Cancer Institute Clackamas Clinic | Clackamas | Oregon | 97015 | United States |
| Bay Area Hospital | Coos Bay | Oregon | 97420 | United States |
| Providence Newberg Medical Center | Newberg | Oregon | 97132 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Providence Saint Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Saint Charles Health System-Redmond | Redmond | Oregon | 97756 | United States |
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| University of Pennsylvania/Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Saint Francis Hospital | Greenville | South Carolina | 29601 | United States |
| Saint Francis Cancer Center | Greenville | South Carolina | 29607 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| Providence Regional Cancer System-Aberdeen | Aberdeen | Washington | 98520 | United States |
| PeaceHealth Saint Joseph Medical Center | Bellingham | Washington | 98225 | United States |
| Providence Regional Cancer System-Centralia | Centralia | Washington | 98531 | United States |
| Swedish Cancer Institute-Edmonds | Edmonds | Washington | 98026 | United States |
| Providence Regional Cancer Partnership | Everett | Washington | 98201 | United States |
| Swedish Cancer Institute-Issaquah | Issaquah | Washington | 98029 | United States |
| Kadlec Clinic Hematology and Oncology | Kennewick | Washington | 99336 | United States |
| Providence Regional Cancer System-Lacey | Lacey | Washington | 98503 | United States |
| PeaceHealth Saint John Medical Center | Longview | Washington | 98632 | United States |
| Pacific Gynecology Specialists | Seattle | Washington | 98104 | United States |
| Swedish Medical Center-Ballard Campus | Seattle | Washington | 98107 | United States |
| Swedish Medical Center-Cherry Hill | Seattle | Washington | 98122-5711 | United States |
| Swedish Medical Center-First Hill | Seattle | Washington | 98122 | United States |
| PeaceHealth United General Medical Center | Sedro-Woolley | Washington | 98284 | United States |
| Providence Regional Cancer System-Shelton | Shelton | Washington | 98584 | United States |
| PeaceHealth Southwest Medical Center | Vancouver | Washington | 98664 | United States |
| Providence Saint Mary Regional Cancer Center | Walla Walla | Washington | 99362 | United States |
| Providence Regional Cancer System-Yelm | Yelm | Washington | 98597 | United States |
| Marshfield Medical Center-EC Cancer Center | Eau Claire | Wisconsin | 54701 | United States |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin | 54548 | United States |
| Cancer Center of Western Wisconsin | New Richmond | Wisconsin | 54017 | United States |
| Marshfield Medical Center-Rice Lake | Rice Lake | Wisconsin | 54868 | United States |
| Marshfield Medical Center-River Region at Stevens Point | Stevens Point | Wisconsin | 54482 | United States |
| Marshfield Medical Center - Weston | Weston | Wisconsin | 54476 | United States |
| Cancer Center-Metro Medical Center Bayamon | Bayamón | 00959-5060 | Puerto Rico |
| Puerto Rico Hematology Oncology Group | Bayamón | 00961 | Puerto Rico |
| Doctors Cancer Center | Manati | 00674 | Puerto Rico |
| San Juan Community Oncology Group | San Juan | 00917 | Puerto Rico |
| Centro Comprensivo de Cancer de UPR | San Juan | 00927 | Puerto Rico |
| PROncology | San Juan | 00927 | Puerto Rico |
| San Juan City Hospital | San Juan | 00936 | Puerto Rico |
| FG001 | Phase Ib Arm B (Dose Level 2) | Dose Level 2: venetoclax 50, 100, 200, 400 mg on Days 1, 2, 3, 4 and 600 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial. |
| FG002 | Phase Ib Arm C (Dose Level 3) | Dose Level 3: - Venetolcax 100, 200, 400, 600 mg on Days 1, 2, 3, 4 and 800 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial. |
| FG003 | Phase II (Venetoclax, Vincristine Liposomal/Sulfate) - Phenotype B-cell ALL/LL | Patients receive combination of venetoclax (600mg, orally once daily, Days 1-28) and liposomal vincristine (2.25mg/m2 IV weekly x 4, starting on Day 1) or vincristine sulfate (1.4mg/m2 IV weekly x 4 [capped at 2mg], starting on Day 1). Due to liposomal vincristine was removed in the US market as of April 2022, no new patients started with liposomal vincristine on this trial and patients receiving liposomal vincristine at that time were switched to vincristine sulfate at the beginning of their next cycle or as the drug supply required, whichever came first. Once a patient switched, patient must have continued with conventional vincristine sulfate for the duration of the trial. |
| FG004 | Phase II (Venetoclax, Vincristine Liposomal/Sulfate) - Phenotype T-cell ALL/LL | Patients receive combination of venetoclax (600mg, orally once daily, Days 1-28) and liposomal vincristine (2.25mg/m2 IV weekly x 4, starting on Day 1) or vincristine sulfate (1.4mg/m2 IV weekly x 4 [capped at 2mg], starting on Day 1). Due to liposomal vincristine was removed in the US market as of April 2022, no new patients started with liposomal vincristine on this trial and patients receiving liposomal vincristine at that time were switched to vincristine sulfate at the beginning of their next cycle or as the drug supply required, whichever came first. Once a patient switched, patient must have continued with conventional vincristine sulfate for the duration of the trial. |
| Never Started Assigned Therapy |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Patients met the eligibility criteria and started protocol treatment
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase Ib Arm A (Dose Level 1) | Dose Level 1: venetoclax 20, 50, 100, 200 mg on Days 1, 2, 3, 4 and 400 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial. |
| BG001 | Phase Ib Arm B (Dose Level 2) | Dose Level 2: venetoclax 50, 100, 200, 400 mg on Days 1, 2, 3, 4 and 600 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial. |
| BG002 | Phase Ib Arm C (Dose Level 3) | Dose Level 3: - Venetolcax 100, 200, 400, 600 mg on Days 1, 2, 3, 4 and 800 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial. |
| BG003 | Phase II (Venetoclax, Vincristine Liposomal/Sulfate) - Phenotype B-cell ALL/LL | Patients receive combination of venetoclax (600mg, orally once daily, Days 1-28) and liposomal vincristine (2.25mg/m2 IV weekly x 4, starting on Day 1) or vincristine sulfate (1.4mg/m2 IV weekly x 4 [capped at 2mg], starting on Day 1). Due to liposomal vincristine was removed in the US market as of April 2022, no new patients started with liposomal vincristine on this trial and patients receiving liposomal vincristine at that time were switched to vincristine sulfate at the beginning of their next cycle or as the drug supply required, whichever came first. Once a patient switched, patient must have continued with conventional vincristine sulfate for the duration of the trial. |
| BG004 | Phase II (Venetoclax, Vincristine Liposomal/Sulfate) - Phenotype T-cell ALL/LL | Patients receive combination of venetoclax (600mg, orally once daily, Days 1-28) and liposomal vincristine (2.25mg/m2 IV weekly x 4, starting on Day 1) or vincristine sulfate (1.4mg/m2 IV weekly x 4 [capped at 2mg], starting on Day 1). Due to liposomal vincristine was removed in the US market as of April 2022, no new patients started with liposomal vincristine on this trial and patients receiving liposomal vincristine at that time were switched to vincristine sulfate at the beginning of their next cycle or as the drug supply required, whichever came first. Once a patient switched, patient must have continued with conventional vincristine sulfate for the duration of the trial. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicity (Phase I) | A dose limiting toxicity (DLT) was defined by the occurrence of any protocol-listed toxicities (CTCAE version 5.0 criteria) possibly, probably, or definitely related to study medication or combination within the first cycle (i.e., ≤ 42 days of first dose of study drug). The phase I portion of this study will use a standard 3+3 design. Escalation would continue until > 33% of a particular dose arm experiences a DLT. The next lower dose arm would be considered the MTD. If < two (2) patients experience a DLT in Arm C, then the Arm C dose would be considered the MTD. | If a patient never starts the study drug, withdraws prior to Day 42 of cycle 1 for non-DLT reasons, is lost to follow up prior to Day 42, or dose not receive 75% of study medications, this slot would be made available for replacement. In total 6 patients were replaced, all were assigned to Arm B. | Posted | Count of Participants | Participants | From start of treatment up to 42 days |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment-Related Toxicities (Phase I) | Toxicities will be assessed and graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | All treated patients | Posted | Count of Participants | Participants | Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 6 years and 11 months |
| ||||||||||||||||||||||||||||||||||
| Primary | Complete Remission (CR) + Complete Remission Incomplete (CRi) Rate (Phase II) | CR+CRi rate (for the best overall response) by the end of cycle 3. A 90% confidence interval will be computed. Tumor response was determined by patient's bone marrow samples that were locally analyzed according to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Acute Lymphoblastic Leukemia; 2019 [updated May 15 2019]. Available from: https://www.nccn.org/professionals/physician\_gls/pdf/all.pdf. | Eligible and treated patients with results reported by phenotype | Posted | Number | 90% Confidence Interval | percentage of participants | Assessed at baseline, then every cycle, up to the end of cycle 3 (1 cycle = 28 days) |
| |||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) (Phase II) | From study registration to documented disease progression or death from any cause, whichever occurs first. PFS will be estimated using the Kaplan-Meier method, and the median PFS along with its corresponding 95% confidence interval will be reported. Progressive disease is defined as a 50% increase in blasts in the marrow. Tumor response was determined by patient's bone marrow samples that were locally analyzed according to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Acute Lymphoblastic Leukemia; 2019 [updated May 15 2019]. Available from: https://www.nccn.org/professionals/physician\_gls/pdf/all.pdf. | Eligible and treated patients with results reported by phenotype | Posted | Median | 95% Confidence Interval | months | While on treatment and every 6 months during follow-up if discontinued for reasons other than PD, up to 5 years from study registration |
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) (Phase II) | From study registration to death from any cause. OS will be estimated using the Kaplan-Meier method, and the median OS along with its corresponding 95% confidence interval will be reported. | Eligible and treated patients with results reported by phenotype | Posted | Median | 95% Confidence Interval | months | While on treatment and every 6 months during follow-up, up to 5 years from study registration |
| |||||||||||||||||||||||||||||||||
| Secondary | Incidence of Toxicities (Phase II) | Toxicity incidences will be assessed and graded according to the CTCAE and will be tabulated by patient cohort. | All treated patients | Posted | Count of Participants | Participants | Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years |
| ||||||||||||||||||||||||||||||||||
| Secondary | Minimal Residual Disease (MRD) Negativity Rate (Phase II) | The MRD response reported here was based on the local assessment (i.e., by site) and met the criteria per protocol: "An MRD negative response must meet the criteria for CR or CRi and have any residual disease <0.01% based on original testing technique." | Eligible and treated patients who had MRD assessment performed at the follow-up visits. | Posted | Number | percentage of participants | Assessed at baseline, then every cycle, up to the end of cycle 3 (1 cycle = 28 days) |
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Intracellular BCL-2 Expression (Phase II) | Will be assessed by flow cytometry and dichotomized into two groups by the median (low versus [vs] high). Univariate Cox proportional hazards (PH) models will be used to evaluate the association of the BCL-2 expression at baseline and immunophenotype (B-cell and T-cell acute lymphoblastic leukemia) with OS and PFS, separately. Logistic regression models will be used to investigate the association of the BCL-2 expression at baseline and immunophenotype with response (CR/CRi/partial remission [PR] vs others by 70 days). Multivariable Cox PH modelling and logistic regression modelling will also be used to adjust for the effect of covariates that are possibly associated with these efficacy outcomes. | Not Posted | Baseline up to 5 years | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Immunophenotype of Acute Lymphoblastic Leukemia (Phase II) | Logistic regression models will be used to investigate the association of the BCL-2 expression at baseline and immunophenotype with response (CR/CRi/PR vs. others by 70 days). Multivariable Cox PH modelling and logistic regression modelling will also be used to adjust for the effect of covariates that are possibly associated with these efficacy outcomes. | Not Posted | Up to 5 years | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Genetic Signature (Phase II) | Will be assessed by next generation sequencing. | Not Posted | Up to 5 years | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | BH3 Profile (Phase II) | Will determine if the BH3 profile is associated with response to combination. | Not Posted | Up to 5 years | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Expression of BCL-2 (Phase II) | Will determine if relative expression of BCL-2 measure by flow cytometry is associated with response to combination. | Not Posted | Up to 5 years | Participants |
Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase Ib Arm A (Dose Level 1) | Dose Level 1: venetoclax 20, 50, 100, 200 mg on Days 1, 2, 3, 4 and 400 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial. | 0 | 3 | 2 | 3 | 3 | 3 |
| EG001 | Phase Ib Arm B (Dose Level 2) | Dose Level 2: venetoclax 50, 100, 200, 400 mg on Days 1, 2, 3, 4 and 600 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial. | 2 | 12 | 9 | 12 | 12 | 12 |
| EG002 | Phase Ib Arm C (Dose Level 3) | Dose Level 3: - Venetolcax 100, 200, 400, 600 mg on Days 1, 2, 3, 4 and 800 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial. | 0 | 3 | 3 | 3 | 3 | 3 |
| EG003 | Phase II (Venetoclax, Vincristine Liposomal/Sulfate) | Patients receive combination of venetoclax (600mg, orally once daily, Days 1-28) and liposomal vincristine (2.25mg/m2 IV weekly x 4, starting on Day 1) or vincristine sulfate (1.4mg/m2 IV weekly x 4 [capped at 2mg], starting on Day 1). Due to liposomal vincristine was removed in the US market as of April 2022, no new patients started with liposomal vincristine on this trial and patients receiving liposomal vincristine at that time were switched to vincristine sulfate at the beginning of their next cycle or as the drug supply required, whichever came first. Once a patient switched, patient must have continued with conventional vincristine sulfate for the duration of the trial. | 17 | 22 | 12 | 21 | 21 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear and labyrinth disorders - Other, specify | Ear and labyrinth disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Cardiac disorders - Other, specify | Cardiac disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Death NOS | General disorders and administration site conditions | CTCAE 5.0 | Systematic Assessment |
| |
| Edema face | General disorders and administration site conditions | CTCAE 5.0 | Systematic Assessment |
| |
| Fever | General disorders and administration site conditions | CTCAE 5.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders and administration site conditions | CTCAE 5.0 | Systematic Assessment |
| |
| Disease progression | General disorders and administration site conditions | CTCAE 5.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Gastric hemorrhage | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | CTCAE 5.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | CTCAE 5.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE 5.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE 5.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE 5.0 | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | CTCAE 5.0 | Systematic Assessment |
| |
| Herpes simplex reactivation | Infections and infestations | CTCAE 5.0 | Systematic Assessment |
| |
| Fungemia | Infections and infestations | CTCAE 5.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | CTCAE 5.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE 5.0 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Stroke | Nervous system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Nervous system disorders - Other, specify | Nervous system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE 5.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear and labyrinth disorders - Other, specify | Ear and labyrinth disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Conduction disorder | Cardiac disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Heart failure | Cardiac disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Cardiac disorders - Other, specify | Cardiac disorders | CTCAE 5.0 | Systematic Assessment |
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| Chills | General disorders and administration site conditions | CTCAE 5.0 | Systematic Assessment |
| |
| Edema limbs | General disorders and administration site conditions | CTCAE 5.0 | Systematic Assessment |
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| Fatigue | General disorders and administration site conditions | CTCAE 5.0 | Systematic Assessment |
| |
| Fever | General disorders and administration site conditions | CTCAE 5.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders and administration site conditions | CTCAE 5.0 | Systematic Assessment |
| |
| Pain | General disorders and administration site conditions | CTCAE 5.0 | Systematic Assessment |
| |
| Generalized edema | General disorders and administration site conditions | CTCAE 5.0 | Systematic Assessment |
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| General disorders and administration site conditions - Other, specify | General disorders and administration site conditions | CTCAE 5.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | CTCAE 5.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Anal hemorrhage | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Bloating | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Fecal incontinence | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Immune system disorders - Other, specify | Immune system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | CTCAE 5.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE 5.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE 5.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE 5.0 | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | CTCAE 5.0 | Systematic Assessment |
| |
| Thrush | Infections and infestations | CTCAE 5.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | CTCAE 5.0 | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE 5.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE 5.0 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| Electrocardiogram QT corrected interval prolonged | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| Fibrinogen decreased | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| INR increased | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| Thyroid stimulating hormone increased | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| Investigations - Other, specify | Investigations | CTCAE 5.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
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| Hyperuricemia | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
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| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
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| Tumor lysis syndrome | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
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| Hyperphosphatemia | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Systematic Assessment |
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| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Systematic Assessment |
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| Ataxia | Nervous system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE 5.0 | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | CTCAE 5.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE 5.0 | Systematic Assessment |
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| Sinus pain | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | CTCAE 5.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Eye disorders - Other, specify | Eye disorders | CTCAE 5.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE 5.0 | Systematic Assessment |
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| Confusion | Psychiatric disorders | CTCAE 5.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Pharyngeal mucositis | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Sleep apnea | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Urine discoloration | Renal and urinary disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Reproductive system and breast disorders - Other, specify | Reproductive system and breast disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Vascular disorders - Other, specify | Vascular disorders | CTCAE 5.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Statistician | ECOG-ACRIN Statistical Office | 617-632-3012 | eatrials@jimmy.harvard.edu |
| Jan 16, 2026 |
| Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D002051 | Burkitt Lymphoma |
| D015452 | Precursor B-Cell Lymphoblastic Leukemia-Lymphoma |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
Not provided
Not provided
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D013129 | Spinal Puncture |
| D009682 | Magnetic Resonance Spectroscopy |
| C579720 | venetoclax |
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D001706 | Biopsy |
| D003943 | Diagnostic Techniques, Neurological |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Phase Ib Arm C (Dose Level 3) | Dose Level 3: - Venetolcax 100, 200, 400, 600 mg on Days 1, 2, 3, 4 and 800 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial. |
|
|
Patients receive combination of venetoclax (600mg, orally once daily, Days 1-28) and liposomal vincristine (2.25mg/m2 IV weekly x 4, starting on Day 1) or vincristine sulfate (1.4mg/m2 IV weekly x 4 [capped at 2mg], starting on Day 1). Due to liposomal vincristine was removed in the US market as of April 2022, no new patients started with liposomal vincristine on this trial and patients receiving liposomal vincristine at that time were switched to vincristine sulfate at the beginning of their next cycle or as the drug supply required, whichever came first. Once a patient switched, patient must have continued with conventional vincristine sulfate for the duration of the trial. |
|
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|
| OG001 | Phase II (Venetoclax, Vincristine Liposomal/Sulfate) - Phenotype T-cell ALL/LL | Patients receive combination of venetoclax (600mg, orally once daily, Days 1-28) and liposomal vincristine (2.25mg/m2 IV weekly x 4, starting on Day 1) or vincristine sulfate (1.4mg/m2 IV weekly x 4 [capped at 2mg], starting on Day 1). Due to liposomal vincristine was removed in the US market as of April 2022, no new patients started with liposomal vincristine on this trial and patients receiving liposomal vincristine at that time were switched to vincristine sulfate at the beginning of their next cycle or as the drug supply required, whichever came first. Once a patient switched, patient must have continued with conventional vincristine sulfate for the duration of the trial. |
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