Combination chemotherapy with or without gemtuzumab in treating young patients with newly diagnosed acute myeloid leukemia

eagle-i ID

Resource Type

Properties

1. ClinicalTrials.gov url

   http://www.clinicaltrial.gov/ct2/show/NCT00372593?term=A+Phase+III+Randomized+Trial+of+Gemtuzumab+Ozogamicin+%28Mylotarg%C2%AE%29+Combined+with+Conventional+Chemotherapy+for+De+Novo+Acute+Myeloid+Leukemia+%28AML%29+in+Children%2C+Adolescents%2C+and+Young+Adults&rank=1

2. Intervention

   gemtuzumab

3. Additional Topic(s)

   Down Syndrome

4. Additional Topic(s)

   antneoplastic combined chemotherapy

5. Additional Topic(s)

   drug dosage

6. Resource Description

   Nearly 500 children are diagnosed with AML every year and half are cured with standard therapy. In other words, half of the children diagnosed with AML and treated as described above remain with no signs of cancer (remission) for five years. The overall goal of this study is to see if we can increase this cure rate without causing more serious side effects of therapy. Researchers want to know if they can improve the cure rate for AML by adding a new chemotherapy drug, called gemtuzumab, to the standard chemotherapy treatments. gemtuzumab has been studied in adults with AML in combination with standard chemotherapy drugs. It has also been studied in small groups of pediatric patients. These studies have determined what dose of gemtuzumab can be given safely with other chemotherapy drugs. Subjects (people participating in the study) will receive one of two different treatment plans. Subjects will be assigned to either Arm A, the current standard therapy, or Arm B, which is considered the experimental arm. Arm B uses the current standard therapy in combination with gemtuzumab. Gemtuzumab has been given to children with AML before but it has not yet been compared to the current therapy to see if it improves outcome. Another goal of this study is to determine which children with AML need a stem cell transplant and which children do not. During intensification treatment, the study doctors will assign subjects to either receive more chemotherapy, or a stem cell transplant. This is decided based on two factors: 1) the subject’s risk of AML coming back, and 2) if they have a matched stem cell donor available. We will also be studying how well children with Down syndrome do on the standard therapy. Down syndrome patients may respond differently to chemotherapy drugs than patients without Down syndrome. This study will give study doctors information about how Down syndrome patients respond to standard therapy. Subjects with Down syndrome enrolled on this study will not be randomized, and will be assigned to Arm A, the standard therapy. Prior studies of children with Down syndrome and AML show that they are often more responsive to treatment but have more complications than children without Down syndrome. Therefore, there needs to be more experience gained in treating children with Down syndrome and they will not receive the additional experimental drug in this study.

7. Additional Name

   Phase III Randomized Trial of Gemtuzumab Ozogamicin (Mylotarg) Combined With Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults

8. Contact

   Berenberg, Jeffrey

9. PI

   Wilkinson, Robert, M.D.

10. Topic

    acute myeloid leukemia

11. Study Population

    Males and females up to age 29; if the patient also has Down syndrome, they must be age 4 or older.

12. Website(s)

    http://www.cancer.gov/clinicaltrials/search/view?cdrid=487497&version=healthprofessional

13. Website(s)

    http://www.curesearch.org/our_research/index_sub.aspx?id=7318

14. Funded by

    Children's Oncology Group

15. Phase

    Phase 3 clinical trial

16. Performed by

    Clinical Protocol & Data Management Shared Resource