Venetoclax Plus Inotuzumab for B-ALL

Status Recruiting

Clinical Trial Summary

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: - Venetoclax - Inotuzumab ozogamicin - Dexamethasone

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

ALL
B-cell Acute Lymphoblastic Leukemia
B-Cell Lymphoma
Leukemia
Leukemia, Lymphoid
Lymphoma, B-Cell
Precursor Cell Lymphoblastic Leukemia-Lymphoma

Clinical Trial Details

NCT number	NCT05016947
Study type	Interventional
Source	Dana-Farber Cancer Institute
Contact	Marlise R Luskin, MD, MSCE
Phone	617-632-1906
Email	marlise_luskin@dfci.harvard.edu
Status	Recruiting
Phase	Phase 1
Start date	September 24, 2021
Completion date	June 23, 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05365659` - IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas	Phase 1
Withdrawn	`NCT05929716` - An Open-Label, Single Center Phase 2 Study of Magrolimab, Rituximab and Radiation as Bridging Strategy Before CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-cell Lymphoma	Phase 2
Active, not recruiting	`NCT05024045` - Study of Oral LOXO-338 in Patients With Advanced Blood Cancers	Phase 1
Completed	`NCT02900716` - Safety Study of BTK Inhibitor, DTRMWXHS-12, Used Singly or in Combination, in CLL and B-cell Lymphomas	Phase 1
Completed	`NCT03068416` - CD19-targeting, 3rd Generation CAR T Cells for Refractory B Cells Malignancy	Phase 2
Not yet recruiting	`NCT05014100` - Orelabrutinib in Combination With R2 Regimen for R/R CD20+ B-cell Lymphoma	Phase 2
Recruiting	`NCT05934838` - A Feasibility Trial of Tazemetostat Plus CAR T Cell Therapy in B-cell Lymphomas	Phase 1
Terminated	`NCT04023071` - FT516 in Subjects With Advanced Hematologic Malignancies	Phase 1
Active, not recruiting	`NCT04148430` - A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy	Phase 2
Completed	`NCT02933320` - BI-1206 and an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Lymphoma or Leukaemia	Phase 1/Phase 2
Active, not recruiting	`NCT03133221` - 1630GCC: Zydelig Maintenance in B-Cell Non-Hodgkin's Lymphoma After Autologous Stem Cell Transplantation	Phase 2
Completed	`NCT02741388` - A Phase Ib Study of Oral Selinexor in Adult Patients With Relapsed/Refractory B-cell Lymphoma Receiving R-DHAOx or R-GDP	Phase 1
Completed	`NCT02300402` - Detection and Characterization of Residual Masses in Lymphomas
Terminated	`NCT02266147` - Study of SD-101 in Combination With Localized Low-dose Radiation in Patients With Untreated Low-grade B-cell Lymphoma	Phase 1/Phase 2
Terminated	`NCT00906841` - Study of 90Y-DOTA-hLL2 as a Consolidation Therapy After R-CHOP in Patients With Diffuse Large B-cell Lymphoma	Phase 2
Completed	`NCT00338494` - Dose Escalation Study of Clofarabine in Patients With Relapsed or Refractory Low Grade or Intermediate-Grade B-Cell Lymphoma	Phase 1
Recruiting	`NCT05487651` - Allogeneic NK T-Cells Expressing CD19 Specific CAR in B-Cell Malignancies	Phase 1
Withdrawn	`NCT05570188` - Anti-CD19 Universal CAR-NK Cells Therapy Combined With HSCT for B Cell Hematologic Malignancies	Phase 1/Phase 2
Recruiting	`NCT03281551` - Efficacy and Safety of PZ01 Treatment in Patients With r/r CD19+ B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma	Phase 1
Completed	`NCT03734601` - Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell Transplantation	Phase 2