Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

busulfan

+ cyclophosphamide
+ cytarabine
Drug
Procedure
Radiation
Who is being recruted

Leukemia

+ Myelodysplastic Syndromes
From 16 to 70 Years
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: November 2003

Summary

Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last updated: July 16, 2012
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2003Actual date on which the first participant was enrolled.

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. OBJECTIVES: Primary * Determine the feasibility of combining gemtuzumab ozogamicin with idarubicin and cytarabine with or without cyclophosphamide with total body irradiation vs busulfan followed by allogeneic stem cell transplantation in patients with previously untreated high-risk myelodysplastic syndromes (MDS) or acute myeloid leukemia secondary to MDS. * Determine the toxicity profile of this regimen in these patients. * Determine the antileukemic/anti-MDS activity of this regimen in these patients. Secondary * Determine the hepatotoxicity of this regimen, in terms of veno-occlusive disease, in these patients. * Determine the severity of pancytopenia and duration of recovery in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 treatment groups. * Group 1 (for patients with no HLA-matched sibling donor): Patients receive remission-induction chemotherapy comprising idarubicin IV over 5 minutes on days 1, 3, and 5; cytarabine IV continuously over 24 hours on days 1-10; and gemtuzumab ozogamicin IV over 2 hours on day 7. Treatment continues for a second course in the absence of unacceptable toxicity. * Group 2 (for patients with an HLA-matched sibling donor): Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive myeloablative consolidation chemotherapy comprising cyclophosphamide on days -6 and -5 and total body irradiation twice daily on days -4 to -2. * Arm II: Patients receive myeloablative consolidation chemotherapy comprising busulfan on days -8 to -5 and cyclophosphamide on days -4 and -3. Patients in both arms may alternatively undergo T-cell depletion and/or a reduced-intensity conditioning regimen. Approximately 4-8 weeks after completion of consolidation chemotherapy, all patients in group 2 undergo allogeneic bone marrow transplantation or allogeneic peripheral blood stem cell transplantation. Patients in group 2 then proceed to remission-induction chemotherapy as in group 1. Patients achieving complete remission are recommended for consolidation therapy off study. Patients are followed monthly for 6 months, every 2 months for 6 months, and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study within 10 months.

Official TitleIdarubicin and Ara-C in Combination With Gemtuzumab-Ozogamicin (IAGO) for Young Untreated Patients, Without an HLA Identical Sibling, With High Risk MDS or AML Developing After a Preceding Period With MDS During 6 Months Duration: A Phase II Study 
Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last updated: July 16, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
31 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 16 to 70 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Leukemia
Myelodysplastic Syndromes
Criteria

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


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 9 locations
Suspended
AZ Sint-JanBrugge, BelgiumSee the location
Suspended
Institut Jules BordetBrussels, Belgium
Suspended
Cliniques Universitaires Saint-LucBrussels, Belgium
Suspended
H. Hartziekenhuis - Roeselaere.Roeselare, Belgium

Completed9 Study Centers