LeukemiaPhase 2NCT00002800
Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome
A Phase 2 study testing filgrastim, lintuzumab and cytarabine in people with Leukemia and Myelodysplastic Syndromes, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of high-dose cytarabine plus idarubicin in treating patients with newly diagnosed acute or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myelodysplastic Syndromes, Neutropenia
- What is being tested?
- filgrastim, lintuzumab and cytarabine
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1996to Mar 2003
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: One of the following hematologic malignancies that is ineligible for higher priority protocols and confirmed at Memorial Hospital: Acute myelogenous leukemia Accelerated or blastic phase (greater than 10% blasts in marrow) chronic myelogenous leukemia Poor-risk myelodysplastic syndrome, defined as: Refractory anemia with excess blasts (RAEB) with at least 10% marrow blasts and cytopenia requiring therapy RAEB in transformation Chronic myelomonocytic leukemia No acute promyelocytic leukemia
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL Transaminases no greater than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No cardiomyopathy No symptomatic congestive heart failure Other: No concurrent active malignancy No pregnant or nursing women
PRIOR CONCURRENT THERAPY: No prior therapy except biologic agent alone or hydroxyurea
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: PHASE II STUDY OF HIGH DOSE CYTARABINE COMBINED WITH A SINGLE HIGH DOSE OF IDARUBICIN FOR NEWLY DIAGNOSED PATIENTS WITH AML: THE AML-3 PROTOCOL
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of high-dose cytarabine plus idarubicin in treating patients with newly diagnosed acute or chronic myelogenous leukemia or myelodysplastic syndrome.
Read the detailed description
OBJECTIVES: I. Evaluate the effect of combined intensive induction and postremission therapy with high-dose cytarabine plus a single high dose of idarubicin in patients with previously untreated acute myelogenous leukemia (AML). II. Identify cytogenetic, molecular, or immunophenotypic markers in AML patients for use in the study of residual disease.
OUTLINE: All patients receive high dose cytarabine for 5 days and idarubicin on the third day as induction chemotherapy. Patients who achieve a complete remission (CR) proceed to consolidation chemotherapy, as follows: cytarabine and etoposide for 5 days; and, for patients aged 60 and under, cytarabine for 4 days, with idarubicin on the third day. Patients eligible for the second consolidation course may have peripheral blood stem cells collected following this regimen. Patients with an HLA-compatible donor then proceed to allogeneic bone marrow transplantation, while patients over age 60, those with the t(8;21) or inv16 cytogenetic abnormality, and those without an HLA-compatible donor receive maintenance therapy with the humanized monoclonal antibody M195 twice weekly for 3 weeks, then monthly for 5 months. G-CSF is administered with each chemotherapy regimen. Patients are followed for survival.
PROJECTED ACCRUAL: 60 patients will be entered over 3 years.
- Conditions
- Leukemia, Myelodysplastic Syndromes, Neutropenia
- Being tested
- filgrastim, lintuzumab, cytarabine, etoposide, idarubicin
- Keywords
- accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, untreated adult acute myeloid leukemia, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia, de novo myelodysplastic syndromes, neutropenia
- Medical subject headings
- Leukemia, Myelodysplastic Syndromes, Neutropenia, Leukemia, Myeloid, Accelerated Phase, Blast Crisis, Anemia, Refractory, with Excess of Blasts, Leukemia, Myelomonocytic, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
lintuzumabBiological
cytarabineDrug
etoposideDrug
idarubicinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2004 (estimated)
- Study startJul 1996
- Primary completionMar 2003
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Peter Maslak, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002800
- Sponsor's protocol ID
- 96-044
- Other IDs
- CDR0000064897, NCI-V96-0941
- Status last verified
- Jul 2013
- First submitted
- 1 Nov 1999
- Last updated
- 3 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE II STUDY OF HIGH DOSE CYTARABINE COMBINED WITH A SINGLE HIGH DOSE OF IDARUBICIN FOR NEWLY DIAGNOSED PATIENTS WITH AML: THE AML-3 PROTOCOL
- ClinicalTrials.gov ID
- NCT00002800
- Acronym / sponsor ID
- 96-044
- Conditions
- Leukemia, Myelodysplastic Syndromes, Neutropenia
- Keywords
- accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, untreated adult acute myeloid leukemia, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia, de novo myelodysplastic syndromes, neutropenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 1996
- Primary completion
- Mar 2003 (actual)
- Study completion
- Mar 2003 (actual)
- First posted
- 22 Apr 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of high-dose cytarabine plus idarubicin in treating patients with newly diagnosed acute or chronic myelogenous leukemia or myelodysplastic syndrome.
Detailed description
OBJECTIVES: I. Evaluate the effect of combined intensive induction and postremission therapy with high-dose cytarabine plus a single high dose of idarubicin in patients with previously untreated acute myelogenous leukemia (AML). II. Identify cytogenetic, molecular, or immunophenotypic markers in AML patients for use in the study of residual disease.
OUTLINE: All patients receive high dose cytarabine for 5 days and idarubicin on the third day as induction chemotherapy. Patients who achieve a complete remission (CR) proceed to consolidation chemotherapy, as follows: cytarabine and etoposide for 5 days; and, for patients aged 60 and under, cytarabine for 4 days, with idarubicin on the third day. Patients eligible for the second consolidation course may have peripheral blood stem cells collected following this regimen. Patients with an HLA-compatible donor then proceed to allogeneic bone marrow transplantation, while patients over age 60, those with the t(8;21) or inv16 cytogenetic abnormality, and those without an HLA-compatible donor receive maintenance therapy with the humanized monoclonal antibody M195 twice weekly for 3 weeks, then monthly for 5 months. G-CSF is administered with each chemotherapy regimen. Patients are followed for survival.
PROJECTED ACCRUAL: 60 patients will be entered over 3 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| filgrastim | Biological | – |
| lintuzumab | Biological | – |
| cytarabine | Drug | – |
| etoposide | Drug | – |
| idarubicin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Maslak, MD study chair
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing filgrastim, lintuzumab and cytarabine in people with Leukemia and Myelodysplastic Syndromes, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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 3 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Where can I read the original study information?
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 3 Jul 2013.