Inotuzumab Ozogamicin in Children and Young Adults With Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia

Summary

This study focuses on children and young adults who have been diagnosed with B-acute lymphoblastic leukemia (B-ALL) that is either unresponsive to therapy (refractory) or has come back after treatment (relapsed). B-ALL is a cancer of the white blood cells. The goal of the study is to determine the effects of an investigational drug called inotuzumab ozogamicin (InO) when combined with chemotherapy in children and young adults with relapsed or refractory B-ALL. Inotuzumab ozogamicin (InO) is an antibody that is linked to a chemotherapy drug. Antibodies are large proteins that function to identify and remove foreign substances. Once attached to a cancer cell, InO is taken inside the cancer cell and the chemotherapy is released, causing the cancer cell to die. In the first part of the study (which was completed), subjects received InO alone. In this part of the study, researchers aim to determine whether InO can be safely combined with a standard chemotherapy treatment block used for children with newly diagnosed B-ALL (called “consolidation”).


Inclusion Criteria

  • Patients must be >= 1 year and < 22 years of age at the time of enrollment
  • Patients must have B-ALL, or previously diagnosed B lymphoblastic lymphoma (B-LL), with >= 5% (M2 or M3) bone marrow blasts with or without extramedullary disease
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Study Location(s)

Cedars-Sinai Cancer at SOCC : Karla Russell

More about this Clinical Trial

Full Title

AALL1621: A Phase 2 Study of Inotuzumab Ozogamicin in Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia

Details
Disease Type/Condition

Leukemia, other

Principal Investigator

Majlessipour, Fataneh

Co-Investigators

Nicole Baca

Age Group

Both

Phase

II

IRB Number

STUDY00002473

ClinicalTrials.gov ID

NCT02981628

Key Eligibility
ClinicalTrials.gov

Contact
Name

Karla Russell

Phone
310-423-2133
Email
karla.russell@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Leukemia, other

Principal Investigator

Majlessipour, Fataneh

Age Group

Both

Phase

II

IRB Number

AALL1621

ClinicalTrials.gov ID

NCT02981628

Key Eligibility
ClinicalTrials.gov

Contact
Name

Karla Russell

Phone
310-423-2133
Email
karla.russell@cshs.org
Want to join the study or
learn more?