Blood Cancer

EA9152



Venetoclax and Vincristine Liposomal in Treating Patients with Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia

STATUS: Temporarily Closed to Accrual


This phase Ib / II trial studies the side effects and best dose of venetoclax and how well it works when given together with vincristine liposomal 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 liposomal, 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 liposomal may work better in treating patients with acute lymphoblastic leukemia compared to vincristine liposomal alone.
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 0: Patient must be considered a potential candidate for the trial * NOTE: Enrollment to Step 0 may occur prior to or following completion of the assessments to verify patient eligibility for Step 1 registration; bone marrow and/or peripheral blood specimens collected during Step 0 or prior to treatment on Step 1 must be submitted for central review in order for the patient to be considered evaluable; results will not be reported to the site and will not impact patient participation in the trial

  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients must have a diagnosis of: * Relapsed or refractory B-cell or T-cell ALL after multi-agent chemotherapy * Patients with < 5% blasts may enroll on trial in phase I portion provided that minimal residual disease (MRD) is present at > 10^-3 as tested on an assay with minimum sensitivity of 10^-4 OR * Relapsed lymphoblastic lymphoma

  • 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 * Patients with WBC count above 25 x 10^9/L are eligible if they have started steroids or hydroxyurea per institutional guidelines

  • 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: 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: 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. * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

  • 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. * Should a patient pr a partner of a patient become pregnant or suspect they are pregnant while participating in the study, the treating physician should be notified immediately

  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: No evidence of prior 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 with isolated testicular or central nervous system (CNS) relapsed disease are not eligible

  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patient 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: Patient 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 I (ARMS A, B, C) - STEP 1: Patient 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: * Strong and moderate CYP3A inhibitors; * Strong and moderate CYP3A inducers

  • 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 0: Patient must be considered a potential candidate for the trial * NOTE: Enrollment to Step 0 may occur prior to or following completion of the assessments to verify patient eligibility for Step 1 registration

  • 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: Patients with prior venetoclax treatment for ALL will be excluded

  • 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 * Patients with WBC count above 25 x 10^9/L are eligible if they have started steroids or hydroxyurea per institutional guidelines

  • 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: 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: 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. * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

  • 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 to abstain from sexual intercourse by abstaining duration of their participation in the study and for 30 days after the last dose of venetoclax * Should a patient or partner of a patient become pregnant or suspect she is pregnant while participating in this study, the treating physician should be informed immediately

  • 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: Patient 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: Patient 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

  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patient 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 should not have received the following within 7 days prior to the first dose of study drug: * Strong and moderate CYP3A inhibitors; * Strong and moderate CYP3A inducers

  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients must not have grade 3 or higher peripheral neuropathy history of grade 3 peripheral neuropathy; patients with familial demyelinating diseases like Charcot-Marie-Tooth disease also excluded

United States
AK
Anchorage
Alaska Breast Care and Surgery LLC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Alaska Oncology and Hematology LLC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Alaska Women's Cancer Care
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Anchorage Associates in Radiation Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Anchorage Oncology Centre
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Anchorage Radiation Therapy Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Katmai Oncology Group
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Providence Alaska Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

AR
Ft. Smith
Mercy Hospital Fort Smith
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

AZ
Phoenix
Mayo Clinic Hospital in Arizona
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Scottsdale
Mayo Clinic in Arizona
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

CA
Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Najee.Boucher@providence.org

CT
Hartford
Smilow Cancer Hospital Care Center at Saint Francis
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: canceranswers@yale.edu

New Haven
Smilow Cancer Center / Yale-New Haven Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: canceranswers@yale.edu

Yale University
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: canceranswers@yale.edu

FL
Jacksonville
Mayo Clinic in Florida
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

ID
Boise
Saint Luke's Cancer Institute - Boise
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: eslinget@slhs.org

Fruitland
Saint Luke's Cancer Institute - Fruitland
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: eslinget@slhs.org

Meridian
Saint Luke's Cancer Institute - Meridian
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: eslinget@slhs.org

Nampa
Saint Luke's Cancer Institute - Nampa
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: eslinget@slhs.org

Twin Falls
Saint Luke's Cancer Institute - Twin Falls
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: eslinget@slhs.org

IL
Alton
Saint Anthony's Health
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Bloomington
Illinois CancerCare-Bloomington
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Canton
Illinois CancerCare-Canton
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Carbondale
Memorial Hospital of Carbondale
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.research@sih.net

Carterville
SIH Cancer Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.research@sih.net

Carthage
Illinois CancerCare-Carthage
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Centralia
Centralia Oncology Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Chicago
Northwestern University
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancer@northwestern.edu

Decatur
Cancer Care Specialists of Illinois - Decatur
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Dixon
Illinois CancerCare-Dixon
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Effingham
Crossroads Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Eureka
Illinois CancerCare-Eureka
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Galesburg
Illinois CancerCare-Galesburg
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Western Illinois Cancer Treatment Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Kewanee
Illinois CancerCare-Kewanee Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Macomb
Illinois CancerCare-Macomb
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Mount Vernon
Good Samaritan Regional Health Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

O'Fallon
Cancer Care Center of O'Fallon
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Ottawa
Illinois CancerCare-Ottawa Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Pekin
Illinois CancerCare-Pekin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peoria
Illinois CancerCare-Peoria
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Methodist Medical Center of Illinois
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

OSF Saint Francis Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peru
Illinois CancerCare-Peru
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Valley Radiation Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Princeton
Illinois CancerCare-Princeton
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Springfield
Memorial Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: pallante.beth@mhsil.com

Southern Illinois University School of Medicine
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Springfield Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Washington
Illinois CancerCare - Washington
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

KS
Garden City
Central Care Cancer Center - Garden City
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: aroland@kccop.org

Great Bend
Central Care Cancer Center - Great Bend
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: aroland@kccop.org

MD
Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: jhcccro@jhmi.edu

MN
Rochester
Mayo Clinic in Rochester
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

MO
Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Bolivar
Central Care Cancer Center - Bolivar
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: aroland@kccop.org

Branson
Cox Cancer Center Branson
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Cape Girardeau
Saint Francis Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: sfmc@sfmc.net

Southeast Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Farmington
Parkland Health Center - Farmington
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Jefferson City
Capital Region Southwest Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: swooden@mail.crmc.org

Joplin
Freeman Health System
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: LJCrockett@freemanhealth.com

Mercy Hospital Joplin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: esmeralda.carrillo@mercy.net

Rolla
Delbert Day Cancer Institute at PCRMC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@phelpshealth.org

Mercy Clinic-Rolla-Cancer and Hematology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Saint Joseph
Heartland Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: linda.schumacher@mymlc.com

Saint Louis
Mercy Hospital Saint Louis
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Mercy Hospital South
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: janet.lesko@mercy.net

Missouri Baptist Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Saint Louis Cancer and Breast Institute-South City
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Springfield
CoxHealth South Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Mercy Hospital Springfield
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Sullivan
Missouri Baptist Sullivan Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Washington
Mercy Hospital Washington
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

MT
Missoula
Saint Patrick Hospital - Community Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: amy.hanneman@providence.org

NJ
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

NY
New York
Memorial Sloan Kettering Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

OK
Oklahoma City
Mercy Hospital Oklahoma City
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

OR
Bend
Saint Charles Health System
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: nosall@stcharleshealthcare.org

Clackamas
Clackamas Radiation Oncology Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Cancer Institute Clackamas Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Coos Bay
Bay Area Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cherie.cox@bayareahospital.org

Newberg
Providence Newberg Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Portland
Providence Portland Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Redmond
Saint Charles Health System-Redmond
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

PA
Hershey
Penn State Milton S Hershey Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CTO@hmc.psu.edu

Philadelphia
Thomas Jefferson University Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ONCTrialNow@jefferson.edu

University of Pennsylvania / Abramson Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

SC
Greenville
Saint Francis Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: melissa_beckman@bshsi.org

Saint Francis Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: melissa_beckman@bshsi.org

WI
Milwaukee
Medical College of Wisconsin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose of venetoclax in combination with vincristine liposomal (liposomal vincristine) 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 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.

PHASE II: Patients receive venetoclax PO QD on days 1-28 and vincristine liposomal IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 cycles. 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.

After completion of study treatment, patients are followed up every 6 months for 5 years.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.


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