Venetoclax Plus Inotuzumab for B-ALL
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|ClinicalTrials.gov Identifier: NCT05016947|
Recruitment Status : Recruiting
First Posted : August 23, 2021
Last Update Posted : October 20, 2021
This research study is evaluating the safety and efficacy of administering venetoclax and inotuzumab ozogamicin in combination in patients with acute lymphoblastic leukemia (ALL)
The names of the study drugs involved in this study are:
- Inotuzumab ozogamicin
|Condition or disease||Intervention/treatment||Phase|
|B-cell Acute Lymphoblastic Leukemia B-Cell Lymphoma ALL||Drug: Venetoclax Drug: Dexamethasone Drug: Inotuzumab Ozogamicin||Phase 1|
This is a phase I study of venetoclax in combination with inotuzumab ozogamicin for the treatment of CD22-positive (CD22+) B-cell acute lymphoblastic leukemia (B-ALL) and lymphoma (B-LBL), hereafter referred to as "ALL," in patients with disease relapsed from or refractory (R/R) to prior intensive chemotherapy.
The U.S. Food and Drug Administration (FDA) has not approved venetoclax for ALL but it has been approved for other uses. Venetoclax is an oral (pill) chemotherapy that works by blocking the action of certain proteins in cancer cells that help those cells survive.
The U.S. Food and Drug Administration (FDA) has approved inotuzumab ozogamicin as a treatment option for ALL but not in combination with other drugs. Inotuzumab ozogamicin is an antibody-drug conjugate. An antibody-drug conjugate is a medication where a cancer drug (chemotherapy) is attached to an antibody, an immune system protein, that targets a specific protein on the cancer cell. Inotuzumab ozogamicin is combination of an antibody that targets the CD22 protein on ALL cells and calicheamicin, a chemotherapy compound that kills cancer cells. Once the antibody portion of inotuzumab ozogamicin binds to CD22 protein on cancer cells, the calicheamicin is released into the cell, where it damages the cancer cell's DNA and causes its death.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
Participants will receive study treatment for approximately 6-9 months depending on their response to the study treatment and followed for two years after completion of study.
It is expected that 20 to 32 people will take part in this research study.
Abbvie is supporting this research study by providing the study drug venetoclax and funding research tests and procedures.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of Venetoclax in Combination With Inotuzumab Ozogamicin for B-cell Acute Lymphoblastic Leukemia (B-ALL)|
|Actual Study Start Date :||September 24, 2021|
|Estimated Primary Completion Date :||June 23, 2023|
|Estimated Study Completion Date :||June 23, 2026|
Experimental: Venetoclax + Inotuzumab Ozogamicin with Dexamethasone
Phased 28 day treatment cycles with lead in:
Lead In Cycle: Dose escalated venetoclax 1x daily for days 1-3 with and Dexamethasone daily for days 1-3 lead in, 7 days total.
Induction Cycle 1: Dose escalated venetoclax 1x daily for days 1-21, Dexamethasone daily for days 1-4, Inotuzumab ozogamicin on days 1, 8, and 15
Induction Cycle 2: Dose escalated venetoclax 1x daily for days and Inotuzumab ozogamicin on days 1, 8, and 15
Consolidation Cycles: Up to 5 cycles of dose escalated Venetoclax 1x daily for days and Inotuzumab ozogamicin on days 1, 8, and 15
Tablet, taken by mouth
Other Name: Venclexta
Drug: Inotuzumab Ozogamicin
Other Name: Besponsa
- Maximum tolerated dose of venetoclax in combination with inotuzumab ozogamicin [ Time Frame: Enrollment to end of treatment up to 9 months ]Descriptive analysis of highest dose of venetoclax that did not cause a dose limiting toxicity with toxicity type based CTCAE vs 5.0 criteria.
- Morphologic response [ Time Frame: Enrollment to end of treatment up to 9 months ]Proportion of participants who achieve hematologic complete remission with 90% confidence intervals
- Measurable residual disease (MRD)-response [ Time Frame: Enrollment to end of treatment up to 9 months ]Proportion of participants who become MRD-negative by multi-parameter flow cytometry with 90% confidence intervals
- Event-free survival (EFS) [ Time Frame: Enrollment to end of treatment up to 9 months ]Estimated by Kaplan-Meier method
- Disease-free survival (DFS) [ Time Frame: Enrollment to end of treatment up to 9 months ]Estimated by Kaplan-Meier method
- Overall survival (OS). [ Time Frame: Enrollment to end of treatment up to 9 months ]Estimated by Kaplan-Meier method
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): NCT05016947
|Contact: Marlise R Luskin, MD, MSCEfirstname.lastname@example.org|
|Contact: Rebecca J Leonardemail@example.com|
|United States, Massachusetts|
|Brigham and Women's Hospital||Not yet recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Marlise R Luskin, MD, MSCE 617-632-1906 firstname.lastname@example.org|
|Principal Investigator: Marlise R Luskin, MD, MSCE|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Marlise R Luskin, MD 617-632-1906 email@example.com|
|Principal Investigator: Marlise Luskin, MD|
|Principal Investigator:||Marlise R Luskin, MD, MSCE||Dana-Farber Cancer Institute|