Blood Cancer

EA9152



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

STATUS: Active


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.
  • 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): 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 * 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 or 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 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 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 Burkittโ€™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 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: 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: * 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 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 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: Patients must not have Burkittโ€™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 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: 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: * 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 or 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
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

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

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

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

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

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

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

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

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

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

Scottsdale
Mayo Clinic in Arizona
Contact: Site Public Contact

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

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

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

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

FL
Jacksonville
Mayo Clinic in Florida
Contact: Site Public Contact

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

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

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

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

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

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

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

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

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

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

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

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

Saint Mary's Hospital
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Chicago
John H Stroger Jr Hospital of Cook County
Contact: Site Public Contact

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

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

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

Dixon
Illinois CancerCare-Dixon
Contact: Site Public Contact

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

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

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

Western Illinois Cancer Treatment Center
Contact: Site Public Contact

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

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

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

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

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

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

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

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

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

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

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

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

Valley Radiation Oncology
Contact: Site Public Contact

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

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

Southern Illinois University School of Medicine
Contact: Site Public Contact

Springfield Clinic
Contact: Site Public Contact

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

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

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

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

MN
Burnsville
Fairview Ridges Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Minnesota Oncology - Burnsville
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Cambridge
Cambridge Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Coon Rapids
Mercy Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Edina
Fairview Southdale Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Fridley
Unity Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Maple Grove
Fairview Clinics and Surgery Center Maple Grove
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Maplewood
Minnesota Oncology Hematology PA-Maplewood
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint John's Hospital - Healtheast
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Minneapolis
Abbott-Northwestern Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Health Partners Inc
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Hennepin County Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Monticello
Monticello Cancer Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

New Ulm
New Ulm Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Princeton
Fairview Northland Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Robbinsdale
North Memorial Medical Health Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Rochester
Mayo Clinic in Rochester
Contact: Site Public Contact

Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint Paul
Regions Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

United Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Shakopee
Saint Francis Regional Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Stillwater
Lakeview Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Waconia
Ridgeview Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Willmar
Rice Memorial Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Woodbury
Minnesota Oncology Hematology PA-Woodbury
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Wyoming
Fairview Lakes Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

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

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

Branson
Cox Cancer Center Branson
Contact: Site Public Contact

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

Southeast Cancer Center
Contact: Site Public Contact

Farmington
Parkland Health Center - Farmington
Contact: Site Public Contact

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

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

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

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

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

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

Saint Louis
Mercy Hospital Saint Louis
Contact: Site Public Contact

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

Missouri Baptist Medical Center
Contact: Site Public Contact

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

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

Springfield
CoxHealth South Hospital
Contact: Site Public Contact

Mercy Hospital Springfield
Contact: Site Public Contact

Sullivan
Missouri Baptist Sullivan Hospital
Contact: Site Public Contact

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

Washington
Mercy Hospital Washington
Contact: Site Public Contact

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

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

NM
Albuquerque
University of New Mexico Cancer Center
Contact: Site Public Contact
Email: HSC-ClinicalTrialInfo@salud.unm.edu

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

WI
Eau Claire
Marshfield Medical Center-EC Cancer Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Marshfield
Marshfield Medical Center-Marshfield
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Milwaukee
Medical College of Wisconsin
Contact: Site Public Contact

Minocqua
Marshfield Clinic-Minocqua Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

New Richmond
Cancer Center of Western Wisconsin
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Rice Lake
Marshfield Medical Center-Rice Lake
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Weston
Marshfield Medical Center - Weston
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

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.

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.


EA9152 Home Page
ECOG-ACRIN Cancer Research Group