RECRUITING

Venetoclax and Chemotherapy as Frontline Therapy in Older Patients and Patients With Relapsed/Refractory ALL

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This research study is studying a medication called Venetoclax and a chemotherapy regimen as a possible treatment for Acute Lymphoblastic Leukemia. The drugs involved in this study are: * Venetoclax * Standard Chemotherapy (which includes cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, 6-mercaptopurine, etoposide, and cytarabine

Official Title

A Phase Ib Study of the Combination of Venetoclax With Chemotherapy as Frontline Therapy in Older Patients and Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia

Quick Facts

Study Start:2017-10-30

Study Completion:2027-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03319901

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients with previously untreated acute lymphoblastic leukemia (B-cell or T-cell) * Bone marrow involvement with ≥20% lymphoblasts * Age ≥ 60 Years * Patients with relapsed or refractory acute lymphoblastic leukemia (B-cell or T-cell) defined as receiving one or more cytotoxic containing regimens * Bone marrow involvement with ≥5% lymphoblasts * Age ≥ 18 Years * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Refer to Appendix D) * Adequate organ function * Serum total bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN for patients with Gilbert's disease * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 x ULN, unless clearly due to disease involvement * Creatinine clearance \>50 mL/min (calculated according to institutional standards or using Cockcroft-Gault or Modification of Diet in Renal Disease (MDRD) formula) * Women of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (β-hCG) pregnancy test result within 14 days prior to the first dose of study drugs and must agree to use an effective contraception method during the study and for 30 days following the last dose of study drug. Women of non- childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy. Men who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug * Patients or their legally authorized representative must provide written informed consent	* Ph-positive ALL, Burkitt's leukemia/lymphoma, or lymphoblastic lymphoma * Patient is pregnant or breastfeeding * Patients with uncontrolled infection * Hepatitis B or C infection, or known seropositivity for human immunodeficiency virus (HIV) * Major surgery or radiation therapy within 4 weeks prior to the first study dose * Systemic chemotherapy/radiotherapy/investigational therapy within 14 days (with the exception of hydroxyurea and/or dexamethasone, or one dose of cytarabine) prior to starting therapy * Symptomatic or untreated leptomeningeal disease or spinal cord compression * Patients with active heart disease (New York Heart Association (NYHA) class 3-4 as assessed by history and physical examination, unstable angina/stroke/myocardial infarction within the last 6 months) * Patients with a cardiac ejection fraction (as measured by either Multi Gated Acquisition (MUGA) or echocardiogram (EKG)) \<40% * History of another primary invasive malignancy that has not been definitively treated or in remission for at least 2 years. Patients with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis (including concomitant diagnoses) * Concurrent use of warfarin * Received Cytochrome P450 3A (CYP3A) inhibitors (such as fluconazole, ketoconazole, voriconazole, and clarithromycin) within 3 days of starting venetoclax; received strong CYP3A inducers (such as rifampin, rifabutin, phenytoin, carbamazepine, and St. John's Wort) within 3 days of starting venetoclax * Consumed grapefruit, grapefruit products, Seville oranges, or star fruit within 3 days prior to starting venetoclax * Prior treatment with venetoclax * Malabsorption syndrome or other conditions that preclude enteral route of administration * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or would make the patient inappropriate for enrollment into this study

Inclusion Criteria

Exclusion Criteria

* Patients with previously untreated acute lymphoblastic leukemia (B-cell or T-cell)
* Bone marrow involvement with ≥20% lymphoblasts
* Age ≥ 60 Years
* Patients with relapsed or refractory acute lymphoblastic leukemia (B-cell or T-cell) defined as receiving one or more cytotoxic containing regimens
* Bone marrow involvement with ≥5% lymphoblasts
* Age ≥ 18 Years
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Refer to Appendix D)
* Adequate organ function
* Serum total bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN for patients with Gilbert's disease
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 x ULN, unless clearly due to disease involvement
* Creatinine clearance \>50 mL/min (calculated according to institutional standards or using Cockcroft-Gault or Modification of Diet in Renal Disease (MDRD) formula)
* Women of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (β-hCG) pregnancy test result within 14 days prior to the first dose of study drugs and must agree to use an effective contraception method during the study and for 30 days following the last dose of study drug. Women of non- childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy. Men who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug
* Patients or their legally authorized representative must provide written informed consent

* Ph-positive ALL, Burkitt's leukemia/lymphoma, or lymphoblastic lymphoma
* Patient is pregnant or breastfeeding
* Patients with uncontrolled infection
* Hepatitis B or C infection, or known seropositivity for human immunodeficiency virus (HIV)
* Major surgery or radiation therapy within 4 weeks prior to the first study dose
* Systemic chemotherapy/radiotherapy/investigational therapy within 14 days (with the exception of hydroxyurea and/or dexamethasone, or one dose of cytarabine) prior to starting therapy
* Symptomatic or untreated leptomeningeal disease or spinal cord compression
* Patients with active heart disease (New York Heart Association (NYHA) class 3-4 as assessed by history and physical examination, unstable angina/stroke/myocardial infarction within the last 6 months)
* Patients with a cardiac ejection fraction (as measured by either Multi Gated Acquisition (MUGA) or echocardiogram (EKG)) \<40%
* History of another primary invasive malignancy that has not been definitively treated or in remission for at least 2 years. Patients with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis (including concomitant diagnoses)
* Concurrent use of warfarin
* Received Cytochrome P450 3A (CYP3A) inhibitors (such as fluconazole, ketoconazole, voriconazole, and clarithromycin) within 3 days of starting venetoclax; received strong CYP3A inducers (such as rifampin, rifabutin, phenytoin, carbamazepine, and St. John's Wort) within 3 days of starting venetoclax
* Consumed grapefruit, grapefruit products, Seville oranges, or star fruit within 3 days prior to starting venetoclax
* Prior treatment with venetoclax
* Malabsorption syndrome or other conditions that preclude enteral route of administration
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or would make the patient inappropriate for enrollment into this study

Contacts and Locations

Study Contact

Marlise Luskin, MD, MSCE

CONTACT

617-632-1909

Marlise_Luskin@DFCI.HARVARD.EDU

Rebecca Leonard

CONTACT

Rebecca_leonard@dfci.harvard.edu

Principal Investigator

Marlise Luskin, MD, MSCE

PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Study Locations (Sites)

University of Chicago

Chicago, Illinois, 60637

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02115

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Intermountain LDS Hospital

Salt Lake City, Utah, 84143

United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

Marlise Luskin, MD, MSCE, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-10-30

Study Completion Date2027-04-30

Study Record Updates

Study Start Date2017-10-30

Study Completion Date2027-04-30

Terms related to this study

Keywords Provided by Researchers

Leukemia

Additional Relevant MeSH Terms

Leukemia