LeukemiaPhase 1/2NCT00086099
Study Evaluating the Addition of Amifostine (Ethyol®) to Idarubicin and Cytosine Arabinoside in Older Patients With Acute Myeloid Leukemia
A Phase 1/2 study testing Idarubincin and Amufostine (Ethyol) and Idarubincin in people with Leukemia and Acute Myeloid Leukemia, run by MedImmune LLC at 19 sites in 2 countries.
Trial summary
The primary objectives of this study are: 1. To evaluate whether the addition of amifostine will allow for the safe administration of idarubicin at a dose of 21 mg/m² in combination with standard-dose ara-C in older patients with newly diagnosed, previously untreated acute myeloid leukemia (AML); and 2. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Leukemia, Acute Myeloid Leukemia
- What is being tested?
- Idarubincin and Amufostine (Ethyol) and Idarubincin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Jul 2004to Feb 2006
- Phase
- Phase 1/2
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men and women of at least 60 years of age at the time of entry or randomization;
- Histologically proven AML with at least 20% myeloblasts based on bone marrow aspiration and biopsy performed within 5 days prior to entry or randomization; History of prior MDS allowed provided the patient has received no prior cytotoxic therapy for MDS;
- Candidates for aggressive induction chemotherapy in the judgment of the Investigator;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (see Appendix A) documented within 5 days prior to entry or randomization. For patients who are admitted to the hospital for evaluation and treatment of AML, ECOG performance status should be determined prior to admission. For patients who are admitted to the hospital for other reasons (e.g., acute medical problems), ECOG performance status should be determined prior to entry or randomization.
- Must be able to, in the opinion of the Investigator, safely stop taking antihypertensive medication 24 hours prior to amifostine administration;
- Women must be >1 year post-menopausal at the time the informed consent is signed. Men of reproductive potential must agree to practice an effective method of avoiding impregnation (including condom, abstinence, or sterile sexual partner) starting at the initiation of induction therapy (i.e., start of ara-C administration), and must agree to continue using such precautions while receiving idarubicin (± amifostine) and ara-C and for 30 days after the last dose of ara-C therapy;
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- Aspartate transaminase (AST)/alanine transaminase (ALT) less than or equal to 2.5 times upper limit of normal (ULN) within 5 days prior to entry or randomization;
- Serum creatinine less than or equal to 2.0 mg/dL within 5 days prior to entry or randomization;
- Left ventricular ejection fraction (LVEF) greater than or equal to 50% on two-dimensional echocardiography (2-D ECHO) within 5 days prior to entry or randomization;
- Written informed consent (all sites) and HIPAA authorization (USA sites only) obtained from the patient prior to receipt of any study medication or beginning study procedures.
Who cannot join
- Prior cytotoxic therapy for AML or MDS (hydroxyurea or similar low-dose therapy to control the white count prior to initiation of induction therapy [i.e., start of ara-C administration] is not an exclusion);
- Diagnosis of acute promyelocytic leukemia (FAB M3 AML);
- Prior diagnosis of AHD (Antecedent Hematologic Disorder, e.g. Polycythemia Vera);
- Known central nervous system (CNS) involvement;
- Life expectancy, in the opinion of the Investigator, of < 3 months due to co-morbid conditions unrelated to AML;
- History of prior malignancies within the last six (6 mos.) that have required the administration of systemic cytotoxic chemotherapy or other systemic bone marrow cytotoxic agents or therapies,or radiation therapy of any kind to areas of the body containing bone marrow;
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- History of prior anthracycline use;
- Prior treatment with other investigational agents within 4 weeks prior to entry or randomization;
- Current or planned participation (from the day of entry or randomization through 30 days after the last dose of ara-C therapy) in a research protocol in which an investigational agent or therapy may be administered;
- Infection with human immunodeficiency virus (HIV) or active viral hepatic infections based on patient's medical history elicited by the Investigator within 5 days prior to entry or randomization;
- Any evidence of or history elicited by the Investigator of angina, acute or chronic congestive heart failure, or pericardial effusion within 6 months prior to entry or randomization;
- Any evidence of or history elicited by the Investigator of uncontrolled or refractory hypertension despite medication within 6 months prior to entry or randomization;
- Any evidence of or history elicited by the Investigator of a myocardial infarction within the last 6 months prior to randomization;
- Any evidence of cerebrovascular accident (CVA) with unstable neural deficits within 6 months prior to entry or randomization.
- Any evidence of transient ischemia attack (TIA) or symptomatic cerebrovascular disease within 6 months prior to entry or randomization;
- Any evidence of clinically significant cardiac arrhythmia including prolongation of QT interval that cannot be controlled with medication or is unstable or symptomatic within 2 months prior to entry or randomization;
- A general medical or psychological condition or behavior, including substance dependence or abuse that, in the opinion of the Investigator, might not permit the patient to complete the study or sign the informed consent.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States15 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
Rush University Medical Center
Chicago, Illinois, 60612
Cleveland Clinic Foundation-Hemoatology/Oncology
Cleveland, Ohio, 44195-001
Henry Ford Health System
Detroit, Michigan, 48202
Spectrum Health Hospitals-Cook Research Dept. (No longer recruiting)
Grand Rapids, Michigan, 49503
Great Lakes Cancer Center Management Specialties
Grosse Point Woods, Michigan, 48236
Cancer Management Specialists (No longer Recruiting)
Grosse Pointe Woods, Michigan, 48236
University of Kansas Medical Center
Kansas City, Kansas, 66160
Baptist Clinical Research Center
Memphis, Tennessee, 38120
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Cancer Care Center
New Albany, Indiana, 47150
St. Barnabas Health Care Center
Newark, New Jersey, 07112
Thomas Jefferson University Medical College
Philadelphia, Pennsylvania, 19107
Scripps Cancer Center
San Diego, California, 92121
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157-1082
Israel4 sites
Rambam Medical Center
Haifa, 31096
Rabin Medical Center
Petah Tikva, 49100
Kaplan Med. Center
Rehovot, 76100
Sheba Medical Center
Tel Hasomer, 52620
About this study
Official title: A Phase IB/II, Randomized, Open-Label, Multicenter Study Evaluating Whether the Addition of Amifostine (Ethyol®) Will Enable the Safe Increase in Dose Intensity of Idarubicin in Combination With Cytosine Arabinoside in Older Patients With Newly Diagnosed, Previously Untreated Acute Myeloid Leukemia
The primary objectives of this study are:
- To evaluate whether the addition of amifostine will allow for the safe administration of idarubicin at a dose of 21 mg/m² in combination with standard-dose ara-C in older patients with newly diagnosed, previously untreated acute myeloid leukemia (AML); and
- To estimate the complete remission rate of induction therapy with amifostine, idarubicin (21 mg/m²), plus ara-C or induction therapy with idarubicin (12 mg/m²) plus ara-C in this patient population.
- Conditions
- Leukemia, Acute Myeloid Leukemia
- Being tested
- Idarubincin and Amufostine (Ethyol), Idarubincin
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Idarubincin and Amufostine (Ethyol)Drug
Starting doses of Idarubincin(12,18 mg/m2 to 21 mg/m2), ara-C, plus amofostine (N-36)
IdarubincinDrug
Idarubincin (12mg/m2) and ara-C(N-18)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Idarubicin plus amifostine Receives: Drug: Idarubincin and Amufostine (Ethyol) |
| 2 | Experimental | Idarubincin Receives: Drug: Idarubincin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically significant hematologic and non-hematologic toxicities associated with idarubicin administration
Measured: 30 days after last dose
Incidence rate of amifostine-associated hypotension results in amifostine dose reduction, discontinuation of amifostine, or causes the development of serious cardiovascular or cerebrovascular events will be estimated
Measured: 30 days after last dose
Secondary outcomes (2)
Duration of Complete Remission
Measured: Estimated by analysis cohort using Kaplan-Mier Method
Overall Survival
Measured: 19 mos. after last patient entered or randomized (whichever was earlier).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2004 (estimated)
- Study startJul 2004
- Primary completionDec 2005
- Study completionFeb 2006
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dirk J. Reitsma, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00086099
- Sponsor's protocol ID
- MI-CP103
- Status last verified
- Jan 2009
- First submitted
- 23 Jun 2004
- Last updated
- 29 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IB/II, Randomized, Open-Label, Multicenter Study Evaluating Whether the Addition of Amifostine (Ethyol®) Will Enable the Safe Increase in Dose Intensity of Idarubicin in Combination With Cytosine Arabinoside in Older Patients With Newly Diagnosed, Previously Untreated Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT00086099
- Acronym / sponsor ID
- MI-CP103
- Conditions
- Leukemia, Acute Myeloid Leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 25 Jun 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.
The primary objectives of this study are:
- To evaluate whether the addition of amifostine will allow for the safe administration of idarubicin at a dose of 21 mg/m² in combination with standard-dose ara-C in older patients with newly diagnosed, previously untreated acute myeloid leukemia (AML); and
- To estimate the complete remission rate of induction therapy with amifostine, idarubicin (21 mg/m²), plus ara-C or induction therapy with idarubicin (12 mg/m²) plus ara-C in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Idarubincin and Amufostine (Ethyol)Idarubicin plus amifostine |
| 2 | Experimental | Drug: IdarubincinIdarubincin |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult men and women of at least 60 years of age at the time of entry or randomization;
- Histologically proven AML with at least 20% myeloblasts based on bone marrow aspiration and biopsy performed within 5 days prior to entry or randomization; History of prior MDS allowed provided the patient has received no prior cytotoxic therapy for MDS;
- Candidates for aggressive induction chemotherapy in the judgment of the Investigator;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (see Appendix A) documented within 5 days prior to entry or randomization. For patients who are admitted to the hospital for evaluation and treatment of AML, ECOG performance status should be determined prior to admission. For patients who are admitted to the hospital for other reasons (e.g., acute medical problems), ECOG performance status should be determined prior to entry or randomization.
- Must be able to, in the opinion of the Investigator, safely stop taking antihypertensive medication 24 hours prior to amifostine administration;
Key exclusion criteria (17 listed)
- Prior cytotoxic therapy for AML or MDS (hydroxyurea or similar low-dose therapy to control the white count prior to initiation of induction therapy [i.e., start of ara-C administration] is not an exclusion);
- Diagnosis of acute promyelocytic leukemia (FAB M3 AML);
- Prior diagnosis of AHD (Antecedent Hematologic Disorder, e.g. Polycythemia Vera);
- Known central nervous system (CNS) involvement;
- Life expectancy, in the opinion of the Investigator, of < 3 months due to co-morbid conditions unrelated to AML;
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 |
|---|---|---|
| Idarubincin and Amufostine (Ethyol)Starting doses of Idarubincin(12,18 mg/m2 to 21 mg/m2), ara-C, plus amofostine (N-36) | Drug | 1 |
| IdarubincinIdarubincin (12mg/m2) and ara-C(N-18) | Drug | 2 |
Primary outcome
Clinically significant hematologic and non-hematologic toxicities associated with idarubicin administration
Time frame: 30 days after last dose
Incidence rate of amifostine-associated hypotension results in amifostine dose reduction, discontinuation of amifostine, or causes the development of serious cardiovascular or cerebrovascular events will be estimated
Time frame: 30 days after last dose
2 secondary outcomes
Duration of Complete Remission
Time frame: Estimated by analysis cohort using Kaplan-Mier Method
Overall Survival
Time frame: 19 mos. after last patient entered or randomized (whichever was earlier).
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 29 Jan 2009.
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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.
Dirk J. Reitsma, M.D. study director
MedImmune LLC
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Idarubincin and Amufostine (Ethyol) and Idarubincin in people with Leukemia and Acute Myeloid Leukemia, run by MedImmune LLC at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. 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 29 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Israel. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Clinically significant hematologic and non-hematologic toxicities associated with idarubicin administration (time frame: 30 days after last dose). 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?
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 29 Jan 2009.