A Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03181126|
Recruitment Status : Recruiting
First Posted : June 8, 2017
Last Update Posted : May 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma||Drug: Navitoclax Drug: Chemotherapy Drug: Venetoclax||Phase 1|
Access to an investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Dose Escalation, Open-Label Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma|
|Actual Study Start Date :||November 28, 2017|
|Estimated Primary Completion Date :||March 7, 2020|
|Estimated Study Completion Date :||June 17, 2020|
Experimental: Venetoclax + Navitoclax + Chemotherapy
Venetoclax weight-adjusted doses administered orally every day (QD) starting on Day 1 + navitoclax various, weight-adjusted doses administered orally QD starting on Day 3 + chemotherapy (peg-asparaginase [or any other forms of asparaginase], vincristine, dexamethasone) and tyrosine kinase inhibitor [TKI, if applicable]). This regimen and any of its components may be delayed, reduced or omitted at the discretion of the Investigator.
Other Name: ABT-263Drug: Chemotherapy
peg-asparaginase (or other form of asparaginase, per local standard of care (intravenous) + vincristine (intravenous) + dexamethasone (oral) + tyrosine kinase inhibitor (TKI) (if applicable, oral)Drug: Venetoclax
Other Name: ABT-199 GDC-0199
- Cmax of Venetoclax + Navitoclax [ Time Frame: Up to approximately 9 months ]Maximum observed plasma concentration (Cmax) of venetoclax + navitoclax
- AUC of Venetoclax + Navitoclax [ Time Frame: Up to approximately 9 months ]Area under the plasma concentration-time curve (AUC) of venetoclax + navitoclax
- Tmax of Venetoclax + Navitoclax [ Time Frame: Up to approximately 9 months ]Time to Cmax (Tmax) of Venetoclax + Navitoclax
- CL/F of Venetoclax + Navitoclax [ Time Frame: Up to approximately 9 months ]Apparent oral clearance (CL/F) of venetoclax + navitoclax
- Number of participants with dose-limiting toxicities (DLT) [ Time Frame: Up to approximately 35 days after initial dose of study drug ]A DLT is any Grade 3 or higher non-hematologic adverse event (AE) with exceptions outlined in the protocol. AEs and toxicities that occur beyond the DLT assessment period will also be evaluated by the investigator and AbbVie and may be considered as dose-limiting.
- Progression-free survival (PFS) [ Time Frame: Up to 9 months after the last subject has enrolled into the study ]PFS is defined as the number of days from the date of enrollment to the date of earliest disease progression or death.
- Partial Response (PR) rate [ Time Frame: Up to 9 months after the last subject has enrolled into the study ]PR defined as no peripheral blasts or peripheral blood absolute blast count decreased by ≥ 50% from baseline, bone marrow with 5 - 25% blasts and at least a 50% decrease in bone marrow blast percent from baseline, no evidence of extramedullary disease.
- Number of Participant who Proceed to Stem Cell Transplantation [ Time Frame: Up to 9 months after the last subject has enrolled into the study ]Determine the number of participants who proceed to stem cell transplantation.
- Overall survival (OS) [ Time Frame: Up to 9 months after the last subject has enrolled into the study ]OS is defined as the number of days from the date of enrollment to the date of death.
- Objective response rate (ORR) [ Time Frame: Up to 9 months after the last subject has enrolled into the study ]The proportion of subjects with objective response rate (complete response [CR] + CR incomplete recovery [CRi] + CR without platelet recovery [CRp]) for ALL subjects and (CR+PR) for LL subjects.
- Complete Response (CR) rate [ Time Frame: Up to 9 months after the last subject has enrolled into the study ]CR defined as hematologic recovery (absolute neutrophil count [ANC] greater than or equal to 500/μL; platelet counts greater than or equal to 75,000/μL), evidence of trilineage hematopoiesis in the bone marrow and less than 5% blasts in the bone marrow, absence of circulating blasts, and no evidence of extramedullary disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03181126
|Contact: ABBVIE CALL CENTERfirstname.lastname@example.org|
|United States, California|
|City of Hope||Recruiting|
|Duarte, California, United States, 91010|
|Palo Alto, California, United States, 94304|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|United States, Missouri|
|Washington University-School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|United States, North Carolina|
|Univ NC Chapel Hill||Recruiting|
|Chapel Hill, North Carolina, United States, 27514-4220|
|United States, Ohio|
|Cincinnati Children's Hospital||Not yet recruiting|
|Cincinnati, Ohio, United States, 45229|
|Nationwide Childrens Hospital||Recruiting|
|Columbus, Ohio, United States, 43205|
|United States, Oregon|
|Oregon Health and Science University||Not yet recruiting|
|Portland, Oregon, United States, 97239-3098|
|United States, Tennessee|
|St. Jude Childrens Res Hosp||Recruiting|
|Memphis, Tennessee, United States, 38105|
|United States, Texas|
|UT Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390-7208|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|United States, Wisconsin|
|University of Wisconsin-Madiso||Not yet recruiting|
|Madison, Wisconsin, United States, 53705|
|Alfred Hospital||Not yet recruiting|
|Melbourne, Victoria, Australia, 3004|
|Victorian Comprehensive Cancer||Recruiting|
|Melbourne, Victoria, Australia, 3050|
|Royal Children's Hospital||Not yet recruiting|
|Melbourne, Victoria, Australia, 3052|
|Study Director:||AbbVie Inc.||AbbVie|