NCT05016947

Venetoclax Plus Inotuzumab for B-ALL

Active, enrolled Phase 1 Last updated 29 January 2026

What this trial tests

Phase 1 trial testing Venetoclax in B-cell Acute Lymphoblastic Leukemia in 23 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

24 September 2021

Primary endpoint
10 July 2023

23 December 2026

Quick facts

Lead sponsor	Dana-Farber Cancer Institute
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	24 September 2021
Primary completion	10 July 2023
Estimated completion	23 December 2026
Sites	2 locations across United States

Drugs / interventions tested

• Venetoclax (venetoclax) — full drug profile →
• Dexamethasone (dexamethasone) — full drug profile →
• Inotuzumab Ozogamicin — full drug profile →

Conditions studied

• B-cell Acute Lymphoblastic Leukemia — all drugs for B-cell Acute Lymphoblastic Leukemia →
• B-Cell Lymphoma — all drugs for B-Cell Lymphoma →
• ALL — all drugs for ALL →

Sponsor

Dana-Farber Cancer Institute

Who can join

18 and older, any sex, with B-cell Acute Lymphoblastic Leukemia or B-Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Emerging Role of Venetoclax-Based Treatments in Acute Lymphoblastic Leukemia.
   Aumann S, Shaulov A, Haran A, Gross Even-Zohar N, et al · · 2022 · cited 30× · PMID 36142863 · DOI 10.3390/ijms231810957
2. Treatment of Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia in Adults.
   Saleh K, Fernandez A, Pasquier F. · · 2022 · cited 24× · PMID 35406576 · DOI 10.3390/cancers14071805
3. Inotuzumab ozogamicin in B-cell precursor acute lymphoblastic leukemia: efficacy, toxicity, and practical considerations.
   Rubinstein JD, O'Brien MM. · · 2023 · cited 20× · PMID 37600823 · DOI 10.3389/fimmu.2023.1237738
4. CD22low/Bcl-2high expression identifies poor response to inotuzumab ozogamicin in relapsed/refractory acute lymphoblastic leukemia.
   Wintering A, Ishiyama K, Tamaki S, Tamaki C, et al · · 2023 · cited 15× · PMID 35500285 · DOI 10.1182/bloodadvances.2021006810
5. Inotuzumab ozogamicin for the treatment of adult acute lymphoblastic leukemia: past progress, current research and future directions.
   Short NJ, Jabbour E, Jain N, Kantarjian H. · · 2024 · cited 14× · PMID 38734670 · DOI 10.1186/s13045-024-01552-7
6. Inotuzumab ozogamicin in adult acute lymphoblastic leukemia: Development, current status, and future directions.
   Kantarjian HM, Boissel N, Papayannidis C, Luskin MR, et al · · 2024 · cited 13× · PMID 39093036 · DOI 10.1002/cncr.35505
7. Antibody drug conjugates in the clinic.
   Udofa E, Sankholkar D, Mitragotri S, Zhao Z. · · 2024 · cited 12× · PMID 39545074 · DOI 10.1002/btm2.10677
8. Overcoming Steroid Resistance in Pediatric Acute Lymphoblastic Leukemia-The State-of-the-Art Knowledge and Future Prospects.
   Kośmider K, Karska K, Kozakiewicz A, Lejman M, et al · · 2022 · cited 12× · PMID 35409154 · DOI 10.3390/ijms23073795