Clinical Trial: Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A PHASE III STUDY IN CHILDREN WITH UNTREATED ACUTE MYELOGENOUS LEUKEMIA (AML) OR MYELODYSPLASTIC SYNDROME (MDS)

Brief Summary: Randomized phase III trial to compare the effectiveness of different chemotherapy regimens with or without bone marrow transplantation in treating children who have acute myelogenous leukemia or myelodysplastic syndrome. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which treatment regimen is more effective for acute myelogenous leukemia or myelodysplastic syndrome

Detailed Summary:

OBJECTIVES:

Increase the remission induction rate to greater than 85% in children with untreated acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) by replacing daunorubicin (DNR) with idarubicin (IDA) in intensively timed DCTER chemotherapy (dexamethasone, cytarabine (ARA-C), thioguanine, etoposide, and daunorubicin) in the first 4 days of each course.

Increase the remission rate further by comparing the efficacy of consolidation chemotherapy with intensively timed IDA DCTER/DCTER vs fludarabine (FAMP), ARA-C, and IDA in maintaining remission and in achieving remission in patients with M2 disease (5%-29% blasts in marrow) at the end of induction chemotherapy.

Compare overall survival, event-free survival, and disease-free survival in patients who receive consolidation with IDA DCTER/DCTER vs FAMP, ARA-C, and IDA.

Compare overall survival, event-free survival, and disease-free survival in patients receiving intensification with the Capizzi II regimen (high-dose ARA-C and asparaginase) vs those receiving a matched-related allogeneic bone marrow transplantation.

Compare overall survival, event-free survival, and disease-free survival in patients treated with interleukin-2 (IL-2) vs standard follow up care after Capizzi II intensification.

Determine whether multichannel flow cytometry detection of residual AML on a companion biologic study protocol CCG-B942 predicts outcome, and determine whether any of these treatment regimens eliminates minimal residual disease more effectively than another.

Register all patients with MDS treated or followed at CCG institutions
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • Proportions of patients achieving remission rate during induction therapy [ Time Frame: Up to 42 days ]
  • Proportion of patients dying or with residual disease during induction therapy [ Time Frame: Up to 42 days ]
  • Time to marrow recovery (induction phase) [ Time Frame: Up to 42 days ]
  • Frequency of toxicities, including infectious complications (induction phase) [ Time Frame: Up to 42 days ]
  • Marrow status [ Time Frame: At 14 days ]
  • Percent of blasts [ Time Frame: At the end of induction therapy ]
  • Complete remission at the end of consolidation therapy [ Time Frame: Up to 5 years ]
  • Survival following consolidation [ Time Frame: Up to 5 years ]
  • Event-free survival following consolidation [ Time Frame: Up to 5 years ]
  • Overall survival (intensification) [ Time Frame: Up to 5 years ]
  • EFS (intensification) [ Time Frame: Up to 5 years ]


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: November 24, 2000
Date Started: August 1996
Date Completion:
Last Updated: January 15, 2013
Last Verified: January 2013