Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome

NCT00077116 | Completed Phase 2

• 1 other identifier: EORTC-06013
• Study Type: interventional
• Target: 31
• Locations: 4 countries
• Sites: 9

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as gemtuzumab ozogamicin, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving monoclonal antibody therapy together with chemotherapy may kill more cancer cells. Giving healthy stem cells from a donor whose blood closely resembles the patient's blood will help the patient's bone marrow make new stem cells that become red blood cells, white blood cells, and platelets. PURPOSE: This phase II trial is studying how well giving idarubicin and cytarabine together with gemtuzumab ozogamicin works in treating patients with previously untreated high-risk myelodysplastic syndrome or acute myeloid leukemia secondary to myelodysplastic syndrome.

Conditions

Leukemia; Myelodysplastic Syndromes

Keywords

untreated adult acute myeloid leukemia; refractory anemia with excess blasts; refractory anemia with excess blasts in transformation; chronic myelomonocytic leukemia; de novo myelodysplastic syndromes; secondary myelodysplastic syndromes; adult acute myeloid leukemia with t(8;21)(q22;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with t(15;17)(q22;q12); childhood myelodysplastic syndromes

Outcome Measures

Primary Outcomes (2)

• Rate of complete remission (CR) or complete remission with incomplete recovery of platelets (CRp) as measured by Cheson response criteria after the start of treatment

• Severe toxicity after the start of treatment

Secondary Outcomes (3)

• Disease-free survival from CR/CRp

• Duration of overall survival

• Severity of pancytopenia and duration of recovery in patients who reached CR/CRp after the start of treatment

Interventions

busulfan DRUG

cyclophosphamide DRUG

cytarabine DRUG

gemtuzumab ozogamicin DRUG

idarubicin DRUG

allogeneic bone marrow transplantation PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of 1 of the following: * High-risk myelodysplastic syndromes (MDS), including any of the following: * Refractory anemia with excess blasts (RAEB) with \> 10% blast cells in the bone marrow * RAEB in transformation * Other forms of MDS with multiple (3 or more) chromosomal abnormalities or chromosome 7 abnormalities AND/OR profound cytopenias, defined as neutrophil count \< 500/mm\^3 and/or platelet count \< 20,000/mm\^3 * Chronic myelomonocytic leukemia with \> 5% blast cells in the bone marrow * Chronic myelomonocytic leukemia with neutrophil count \> 16,000/mm\^3 OR monocyte count \> 2,600/mm\^3 * Secondary acute myeloid leukemia supervening after overt MDS of more than 6 months in duration * Patients with or without an HLA-identical sibling * No active CNS leukemia PATIENT CHARACTERISTICS: Age * 16 to 70 Performance status * WHO 0-2 Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) Renal * Creatinine ≤ 1.5 times ULN Cardiovascular * No severe cardiovascular disease * No arrhythmias requiring chronic treatment * No congestive heart failure * No symptomatic ischemic heart disease Pulmonary * No severe lung disease Other * Not pregnant or nursing * Fertile patients must use effective contraception * No HIV positivity * No other concurrent malignant disease * No active uncontrolled infection * No history of alcohol abuse (i.e., averaged less than 5 alcoholic consumptions daily for the past year) * No concurrent severe neurological or psychiatric disease * No other psychological, familial, sociological, or geographical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * More than 6 weeks since prior growth factors Chemotherapy * No prior intensive chemotherapy * More than 6 weeks since prior low-dose chemotherapy or hydroxyurea Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * More than 6 weeks since prior immunosuppressants * No prior participation in this clinical study

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (9)

AZ Sint-Jan

Bruges, 8000, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

H. Hartziekenhuis - Roeselaere.

Roeselare, 8800, Belgium

Location

Ruprecht - Karls - Universitaet Heidelberg

Heidelberg, D-69117, Germany

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Universitaetsspital-Basel

Basel, CH-4031, Switzerland

Location

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Anemia, Refractory, with Excess of Blasts; Leukemia, Myelomonocytic, Chronic; Congenital Abnormalities

Interventions

Busulfan; Cyclophosphamide; Cytarabine; Gemtuzumab; Idarubicin; Peripheral Blood Stem Cell Transplantation; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Anemia, Refractory; Anemia; Leukemia, Myeloid; Myelodysplastic-Myeloproliferative Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Calicheamicins; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Theo De Witte, MD, PhD

  Universitair Medisch Centrum St. Radboud - Nijmegen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2004
• First Posted: February 11, 2004
• Study Start: November 1, 2003
• Primary Completion: November 1, 2006
• Last Updated: July 16, 2012

Record last verified: 2012-07

Locations

DE (1); NL (3); BE (4); CH (1)