AzTrials
AzTrials

LeukemiaPhase 2NCT00077116

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

A Phase 2 study testing busulfan, cyclophosphamide and cytarabine in people with Leukemia and Myelodysplastic Syndromes, run by European Organisation for Research and Treatment of Cancer - EORTC at 9 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 16 to 70 years
Conditions the study is for
Leukemia, Myelodysplastic Syndromes
What is being tested?
busulfan, cyclophosphamide and cytarabine
Type of treatment
Surgery or procedure
How many people
31 participants
Where
9 sitesin 4 countries
Study dates
Nov 2003to Nov 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

9 sites in 4 countries.

9 sites in 4 countries

Belgium4 sites

  • AZ Sint-Jan

    Bruges, 8000

  • Institut Jules Bordet

    Brussels, 1000

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • H. Hartziekenhuis - Roeselaere.

    Roeselare, 8800

Other trials in Belgium

Netherlands3 sites

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 HA

  • Leiden University Medical Center

    Leiden, 2300 CA

  • Universitair Medisch Centrum St. Radboud - Nijmegen

    Nijmegen, NL-6500 HB

Other trials in Netherlands

Germany1 site

  • Ruprecht - Karls - Universitaet Heidelberg

    Heidelberg, D-69117

Other trials in Germany

Switzerland1 site

  • Universitaetsspital-Basel

    Basel, CH-4031

Other trials in Switzerland

About this study

Official title: Idarubicin 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

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.

Read the detailed description

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.

Being tested
busulfan, cyclophosphamide, cytarabine, gemtuzumab ozogamicin, idarubicin
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
Medical subject headings
Leukemia, Myelodysplastic Syndromes, Anemia, Refractory, with Excess of Blasts, Leukemia, Myelomonocytic, Chronic, Congenital Abnormalities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. Severe toxicity after the start of treatment

Secondary outcomes (3)

  1. Disease-free survival from CR/CRp

  2. Duration of overall survival

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2004 (estimated)
  2. Study startNov 2003
  3. Primary completionNov 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00077116
Sponsor's protocol ID
EORTC-06013
Other IDs
EORTC-06013
Status last verified
Jul 2012
First submitted
10 Feb 2004
Last updated
16 Jul 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing busulfan, cyclophosphamide and cytarabine in people with Leukemia and Myelodysplastic Syndromes, run by European Organisation for Research and Treatment of Cancer - EORTC at 9 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Belgium, Netherlands, Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00077116.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2012.

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