Clinical Trial: Cytarabine and Daunorubicin With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes

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

Official Title: Randomised Induction and Post Induction Therapy in Older Patients (≥61 Years of Age) With Acute Myeloid Leukemia (AML) and Refractory Anemia With Excess Blasts (RAEB

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether cytarabine and daunorubicin followed by gemtuzumab ozogamicin is more effective than cytarabine and daunorubicin in treating acute myeloid leukemia or myelodysplastic syndromes.

PURPOSE: This randomized phase III trial is studying cytarabine and two different doses of daunorubicin to see how well they work compared to cytarabine and daunorubicin followed by gemtuzumab ozogamicin in treating older patients with acute myeloid leukemia or myelodysplastic syndromes.


Detailed Summary:

OBJECTIVES:

Primary

  • Compare the event-free and disease-free survival of older patients with acute myeloid leukemia, refractory anemia with excess blasts (RAEB), or RAEB in transformation treated with induction therapy comprising cytarabine in combination with two different doses of daunorubicin followed by cytarabine alone with or without post-induction therapy comprising gemtuzumab ozogamicin.

Secondary

  • Compare the complete remission rate in patients treated with these regimens.
  • Compare the overall survival of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Determine the probability of relapse and death during first complete remission in patients treated with post-induction gemtuzumab ozogamicin.
  • Correlate prognostic factors (e.g., CD33 positivity, multidrug resistance phenotype, or cytogenetics) with probability of complete remission and overall, event-free, and disease-free survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and diagnosis (acute myeloid leukemia [AML] vs myelodysplastic syndromes [MDS]) for induction therapy. Patients are stratified according to participating center, diagnosis (AML vs MDS), induction treatment arm (I vs II), and response to induction therapy (complete remission [CR] vs no CR) for post-induction therapy.

  • Event-free survival after induction therapy
  • Disease-free survival after maintenance therapy


Original Primary Outcome:

Current Secondary Outcome:

  • Complete remission (CR) rate after induction therapy
  • Overall survival after induction therapy
  • Toxicity after induction therapy
  • Toxicity after maintenance therapy
  • Probability of relapse and death in first CR after maintenance therapy
  • Overall survival after maintenance therapy


Original Secondary Outcome:

Information By: Stichting Hemato-Oncologie voor Volwassenen Nederland

Dates:
Date Received: July 19, 2005
Date Started: January 2005
Date Completion:
Last Updated: September 19, 2016
Last Verified: September 2016