Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia

Conditions

• B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
• Recurrent B Acute Lymphoblastic Leukemia
• Refractory B Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample and cerebrospinal fluid collection
• Blinatumomab — BIOLOGICAL
  Given IV
• Bone Marrow Aspiration — PROCEDURE
  Undergo bone marrow aspiration
• Bone Marrow Biopsy — PROCEDURE
  Undergo bone marrow biopsy
• Inotuzumab Ozogamicin — BIOLOGICAL
  Given IV
• Lumbar Puncture — PROCEDURE
  Undergo lumbar puncture
• Ponatinib — DRUG
  Given PO

Study Details

This phase II trial studies how well inotuzumab ozogamicin and blinatumomab with or without ponatinib work in treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is newly diagnosed, has come back after a period of improvement (recurrent), or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug, called ozogamicin. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers ozogamicin to kill them. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving inotuzumab ozogamicin and blinatumomab with or without ponatinib may be effective in treating patients with newly diagnosed, recurrent or refractory CD22 positive B-lineage acute lymphoblastic leukemia.

Key Dates

First listed

Nov 14, 2018

Start date

May 8, 2019

Status verified

Apr 2026

Primary completion

Feb 1, 2027

Completion

Feb 1, 2027

Study Design

Enrollment

84 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1 (inotuzumab ozogamicin, blinatumomab)
  See Detailed Description..
• Experimental: Cohort 2 (inotuzumab ozogamicin, blinatumomab)
  See Detailed Description.
• Experimental: Cohort 3 (inotuzumab ozogamicin, blinatumomab, ponatinib))
  See detailed description

Primary Outcome Measure

Event-free survival [ Time Frame: At 1 year ]

Locations (275)

Find similar trials in Birmingham, AL

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