Introduction

This family protocol summary provides a general overview of the Children's Oncology Group (COG) study AALL1621. It tells who is eligible and gives basic information about the study. More details about the study are in the consent form. You can get this from your oncologist.

AALL1621 is a Phase II clinical trial. A trial is another word for a study. This study (clinical trial) is a therapeutic clinical trial. That means it is done to learn about a treatment - its safety and how well it works. The purpose of a Phase 2 trial is to learn if a new treatment works in treating a specific type of cancer and how it affects the body. Patients are checked for side effects of the treatment and to see whether the cancer shrinks or goes away.

Phase 2 trials are offered to patients whose disease has not responded to standard types of treatments or to patients whose disease doesn't have a standard treatment.

It is important to understand that participating in a clinical trial is entirely voluntary. The decision about whether or not to participate will not affect the care provided by the health care team in any way. You can find additional information about participation in clinical trials at www.childrensoncologygroup.org Always discuss any questions that you may have with your health care team.

Study Number

AALL1621

Official Title

A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518, IND#TBD) in Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)

Study Opening Date

AALL1621 opened on 6/5/2017. The AALL1621 committee hopes to enroll 48 patients. It is expected that this study will remain open for 2.5 years.

General Patient Eligibility

• Age: 1-21 years old
• Diagnosis: Patients with B-Cell acute lymphoblastic leukemia (B-ALL) whose leukemia cells have a certain protein (CD22+) and their leukemia has returned after treatment (recurrent) or their leukemia did not respond to treatment (refractory).

Please consult your doctor to determine whether you or your child may participate in this study.

General Background and Study Goal

The majority of children diagnosed with ALL will be cured of their disease. However, patients who have recurrent or refractory leukemia have a lower chance of being cured because their leukemia is less likely to respond to chemotherapy or bone marrow transplant.

Inotuzumab Ozogamicin (InO) is a chemotherapy drug that looks for the CD22 protein on the leukemia cell to kill it. This drug has been shown to work better than the current best available chemotherapy in adult clinical trials.

The goals of this study are to:

• Determine how many children with relapsed or refractory B-ALL achieve remission (leukemia can no longer be found in the bone marrow) after treatment with InO.
• Determine the side effects of InO in children, including liver injury which has been seen in adults.
• Determine the levels of InO in the blood and how the levels are related to response and side effects

Summary of the Treatment

On this study, each patient will receive the same medications at the exact same time. InO will be given in the vein (IV) on days 1, 8, and 15 over 60 minutes. All children and young adults will receive intrathecal chemotherapy (medication in their spine) during each cycle. Each cycle of therapy lasts 28 days.

Some patients may experience fever, chills, or low blood pressure during the infusion of InO. Each patient will receive medications before each InO infusion to help reduce the reaction to this chemotherapy. Vital signs will be monitored every 15 minutes during the IO infusion, and then every 30 minutes for 1 hour after the infusion is finished.

At the end of cycle 1, a bone marrow aspirate/biopsy, lumbar puncture, and complete blood count (CBC) will be done. Based on the results of these tests, your physician will determine if your child can proceed with this chemotherapy treatment. This treatment can be given for up to 6 cycles.

Special Considerations

Children and young adults with Down syndrome are eligible for this trial and will receive the medication Leucovorin, by mouth, after each intrathecal chemotherapy.

Risks and Side Effects

Chemotherapy can cause side effects during and after treatment. All patients will be closely monitored for possible side effects of the medicines. All risks and side effects will be explained by your treatment team during the consent process. They can answer any questions that you may have about giving permission for you or your child to be in the clinical trial or other aspects of care. Please refer to the consent form for a detailed explanation of the side effects associated with the treatment on this study.

Contact Information

Your child’s oncologist and nurses are the best sources for further information.

Study Chairs

Maureen O'Brien, MD
Cincinnati Children's Hospital Medical Center

FAMILY PROTOCOL SUMMARY REVIEW/APPROVALS