Introduction

This summary is intended to provide a general overview of the Children’s Oncology Group study ACCL0934. It tells who can be in this study and other basic information. The informed consent form has more details of the study.  You can get this from your oncologist.

ACCL0934 is a Cancer Control and Supportive Care (CCLSC) Study. CCLSC studies are performed to help learn how to best deal with or prevent complications of cancer and cancer treatment. CCLSC studies often focus on complications that affect how people feel or what they can do during or after treatment (physical and emotional quality of life).

If you consent to being a part of this study, you or your child will receive one of two different treatment plans. The treatment plan is decided by a process called randomization. Randomization means that the treatment is assigned based on chance. It is a lot like flipping a coin, except that it is done by computer. The randomization process is described in the COG Family Handbook for Children with Cancer.

Participating in a clinical trial is 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 more information about clinical trials at www.childrensoncologygroup.org.  Please be sure to discuss any questions with your treatment team.

Study Number

ACCL0934

Official Title

A Randomized Trial of Levofloxacin to Prevent Bacteremia in Children Being Treated for Acute Leukemia (AL) or Undergoing Hematopoietic Stem Cell Transplantation (HSCT)

Trial Opening Date

ACCL0934 opened on 6/20/2011.  The ACCL0934 study committee hopes to enroll 532 patients. It is expected that this study will remain open for 4 years.

Trial Closing Date

The Stem Cell Transplant arm of ACCL0934 was closed on September 11, 2015 once enough patients were enrolled. The Leukemia arm of ACCL0934 was closed on October 21, 2016 based on results of an interim analysis. This analysis showed that children who received Levofloxacin (those on the experimental arm of the study) remained without significant bloodstream infections more than children who did not receive Levofloxacin (those on the standard arm of the study). As data from this study continues to be evaluated, additional information will be available.

General Patient Eligibility

• Age: 6 months - 21 years
• Scheduled to receive at least two cycles of intensive chemotherapy for AML or relapsed ALL or scheduled to receive a stem cell transplant.

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

General Background and Study Goal

Children undergoing treatment for acute myeloid leukemia (AML), relapsed acute lymphoblastic leukemia (ALL), and children undergoing hematopoietic stem cell transplant (HSCT) are at high risk for developing serious bacterial infections. Studies done on adults show that an antibiotic called levofloxacin may decrease the chances of harm from serious infections during intensive chemotherapy. This study is trying to find out whether treating children with levofloxacin will decrease the number of serious infections. The study is also evaluating:

• the possible risks of taking levofloxacin
• if the use of levofloxacin affects resistance to antibiotics
• if the use of levofloxacin reduces the total number of days of antibiotic use in children receiving intensive chemotherapy treatment.

Summary of the Treatment

Patients will be randomized to receive no levofloxacin (Arm A) or levofloxacin (Arm B) at the time of enrollment on the study. The levofloxacin will be taken by mouth. It can be changed to IV if child cannot swallow medicine.

For children with AML or relapsed ALL

The children with acute leukemia assigned to receive levofloxacin will receive the medication once a day every day during two consecutive cycles of chemotherapy, beginning on the first day of chemotherapy and continuing until the neutrophil (white blood cells that fight infection) count is over 200 and rising or until Day 60, whichever occurs first.

For children undergoing HSCT

The children having a stem cell transplant assigned to receive levofloxacin will start taking the medication 2 days before the infusion of stem cells, continuing until the absolute neutrophil count is over 200 and rising, or until Day 60, whichever occurs first.

Levofloxacin will be stopped if the child is taking other antibiotics for an infection and restarted once they have finished those other antibiotics.

Special Considerations

• The study will not require any additional tests or doctor visits.
• An optional part of the study will test whether or not taking levofloxacin will affect the bacteria that are normally living in the body. Stool specimens or peri-rectal swabs (putting a sterile swab into the rectum for 5 seconds) will be collected.
  • Patients with Leukemia: 3 swabs or specimens will be collected (at the start of study, after first cycle of chemotherapy and after second cycle of chemotherapy).
  • HSCT patients: 2 swabs or stool specimens will be collected (before the SCT and after the SCT when blood counts have recovered).
  • Your child can still participate in the study even if you choose not to have these specimens collected from your child.

Risks and Side Effects

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 your child to be in the clinical trial or other aspects of care.  The study consent form has more details about possible side effects of the treatment in this study.

Contact Information

Your child’s oncologist is the best source for further information.

Study Chair

Sarah Alexander, MD
Hospital for Sick Children

FAMILY PROTOCOL SUMMARY REVIEW/APPROVALS