Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia

Summary

This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them.

Conditions

• Recurrent B Acute Lymphoblastic Leukemia
• Recurrent B Lymphoblastic Lymphoma
• Refractory B Acute Lymphoblastic Leukemia
• Refractory B Lymphoblastic Lymphoma

Interventions

DRUG

Methotrexate

Given IT

DRUG

Pegaspargase

Given IV or IM

DRUG

Vincristine

Given IV

DRUG

Asparaginase Erwinia chrysanthemi

Given Asparaginase Erwinia chrysanthemi

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration and Biopsy

Undergo a bone marrow aspiration and biopsy

DRUG

Calaspargase Pegol

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IV or SC

PROCEDURE

Diagnostic Imaging Testing

Undergo imaging

BIOLOGICAL

Inotuzumab Ozogamicin

Given IV

DRUG

Leucovorin Calcium

Given PO or IV

PROCEDURE

Lumbar Puncture

Undergo lumbar puncture

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Maureen M O'Brien · Children's Oncology Group

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

1 Year

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-19

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Drug

Yes

Countries

• United States
• Puerto Rico

Study Locations