Venetoclax Plus Inotuzumab for B-ALL

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT05016947
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • ALL
  • B-Cell Lymphoma
  • B-cell Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Tablet, taken by mouth
  • Dexamethasone — DRUG
    Taken orally
  • Inotuzumab Ozogamicin — DRUG
    Intravenous infusion

Study Details

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

Key Dates

Start date
Sep 24, 2021
Status verified
Jan 2026
Primary completion
Jul 10, 2023
Completion
Dec 23, 2026

Study Design

Enrollment
23 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Maximum tolerated dose of venetoclax in combination with inotuzumab ozogamicin [ Time Frame: Enrollment to end of treatment up to 9 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115-
Dana Farber Cancer InstituteBostonMassachusetts02115-

Find similar trials in Boston, MA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Brigham and Women's Hospital· Boston, MADana Farber Cancer Institute· Boston, MA

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