Venetoclax and Vincristine in Treating Patients With Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia
A Phase IB/II Study of Venetoclax (ABT-199) in Combination With Liposomal Vincristine or Vincristine Sulfate in Patients With Relapsed or Refractory T-Cell or B-Cell Acute Lymphoblastic Leukemia
3 other identifiers
interventional
40
2 countries
170
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2018
Longer than P75 for phase_1
170 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2018
CompletedFirst Posted
Study publicly available on registry
April 20, 2018
CompletedStudy Start
First participant enrolled
August 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2025
CompletedResults Posted
Study results publicly available
February 25, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
ExpectedApril 2, 2026
March 1, 2026
6.9 years
April 12, 2018
December 26, 2025
March 31, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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)
Secondary Outcomes (4)
Progression Free Survival (PFS) (Phase II)
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)
While on treatment and every 6 months during follow-up, up to 5 years from study registration
Incidence of Toxicities (Phase II)
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)
Assessed at baseline, then every cycle, up to the end of cycle 3 (1 cycle = 28 days)
Other Outcomes (5)
Change in Intracellular BCL-2 Expression (Phase II)
Baseline up to 5 years
Immunophenotype of Acute Lymphoblastic Leukemia (Phase II)
Up to 5 years
Genetic Signature (Phase II)
Up to 5 years
- +2 more other outcomes
Study Arms (2)
Phase Ib (venetoclax, vincristine liposomal)
EXPERIMENTALPatients 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)
EXPERIMENTALPatients 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.
Interventions
Undergo CT scan
Undergo lumbar puncture
Undergo PET scan
Given PO
Given IV
Given IV
Undergo blood sample collection
Eligibility Criteria
You may qualify if:
- 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: 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
- +17 more criteria
You may not qualify if:
- 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:
- 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 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
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)collaborator
- ECOG-ACRIN Cancer Research Grouplead
Study Sites (170)
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508, United States
Anchorage Radiation Therapy Center
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
Manatí, 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
Related Publications (2)
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.
PMID: 39415930RESULTNeil 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
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- ECOG-ACRIN Statistical Office
Study Officials
- PRINCIPAL INVESTIGATOR
Neil D Palmisiano
ECOG-ACRIN Cancer Research Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2018
First Posted
April 20, 2018
Study Start
August 13, 2018
Primary Completion
July 22, 2025
Study Completion (Estimated)
December 31, 2028
Last Updated
April 2, 2026
Results First Posted
February 25, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.