LeukemiaPhase 2NCT00422591
Standard Idarubicin and Cytarabine for the Treatment of Acute Myeloid Leukemia (AML)
A Phase 2 study testing Cytarabine and Idarubicin in people with Leukemia and Acute Myeloid Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find out if standard chemotherapy given with idarubicin and Cytarabine (ara-C) can help to control AML. Objectives: To determine the complete response (CR) rate, event-free survival (EFS) and overall survival (OS) of patients with newly diagnosed acute myeloid leukemia… Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Leukemia, Acute Myeloid Leukemia, AML
- What is being tested?
- Cytarabine and Idarubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Jan 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of 1) AML (WHO classification definition of >/= 20% blasts). Patients with M6 AML with less than 20% blasts are eligible.
- Patients aged 15 to 75 years are eligible. Patients must be chemo-naïve, i.e. not have received any prior chemotherapy (except hydrea) for AML. They could have received transfusions, hematopoietic growth factors or vitamins. Temporary measures such as pheresis or hydrea (0.5 to 5g daily or more for up to 3 days) are allowed .
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2, or 3 at screening.
- Serum biochemical values with the following limits: - creatinine </= 2.0 mg/dl - total bilirubin </= 2.0 mg/dL, unless increase is due to hemolysis - transaminases (SG PT) </= 3x upper limit of normal (ULN)
- Ability to understand and provide signed informed consent.
Who cannot join
- Subjects with Acute Promyelocytic Leukemia (APL).
- Presence of active systemic infection.
- Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results.
- Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, intrauterine device (IUD), diaphragm, abstinence, or condoms by their partner) over the entire course of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Prospective Evaluation of Standard Chemotherapy Regimen of Idarubicin and Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
The goal of this clinical research study is to find out if standard chemotherapy given with idarubicin and Cytarabine (ara-C) can help to control AML.
Objectives:
To determine the complete response (CR) rate, event-free survival (EFS) and overall survival (OS) of patients with newly diagnosed acute myeloid leukemia (AML) receiving standard combination chemotherapy with Idarubicin and cytarabine.
Read the detailed description
Ara-C and idarubicin are designed to interfere with DNA's (the genetic material of cells) ability to repair itself, causing cancer cells to die.
If you are found to be eligible to take part in this study, you will receive treatment with idarubicin and ara-C for up to 8 cycles. One cycle lasts about 4-5 weeks. Cycles 1 and 2 are called induction therapy, which is used to help induce (cause) a remission. Cycles 3 to 8 are called consolidation therapy, which is a type of high-dose chemotherapy often given as the second phase of a cancer treatment.
After Cycle 1, you will have a brief rest period of a few days, before you move on to Cycle 2. On Day 1 of Cycle 1, you will receive cytarabine by vein as a continuous infusion over 4 days. It will only be 3 days if you are age 60 or older. On Days 1-3 of Cycle 1, you will receive idarubicin by vein over 1 hour once a day.
The dose of the study drugs you receive may be changed to help manage side effects (such as nausea and diarrhea) that you may experience. Medications (given by mouth or by vein), such as Tylenol (acetaminophen), may be given before and during treatment to help decrease the risk of such side effects. The study doctor will specify what these medications are.
You will have blood drawn (about 2 teaspoons) for routine tests about once a week during treatment. Starting on Days 21-28, you will have bone marrow collected every 1-2 weeks to check the status of the disease. Blood (about 2 tablespoons) will also be drawn at least twice a week after each cycle of therapy (beginning about 4-6 weeks from the start of treatment each cycle) to check your blood counts.
Cycle 2 will begin after your blood counts have recovered. If at the end of Cycle 1 you have not achieved a remission (disease has decreased), you may receive Cycle 2, which will be similar to Cycle 1.
If the disease is responding to treatment after Cycle 2 (after completion of induction therapy), you will receive up to 6 more cycles of therapy. These cycles are called consolidation therapy. Consolidation therapy is a type of high-dose chemotherapy often given as the second phase to treat cancer. For consolidation therapy, you will receive ara-C as a continuous infusion over 3 days starting on Day 1 of Cycle 3. On Days 1 and 2 of Cycles 3 and 4, you will receive idarubicin by vein over 1 hour. Your blood (about 2 tablespoons) will be drawn at least twice a week after each cycle to check your blood counts. Cycle 3 will begin after your blood counts have recovered.
After completion of consolidation therapy, you may receive what is called maintenance therapy. Maintenance therapy will start after completion of consolidation therapy. Maintenance therapy is often given to help keep cancer in remission. It is treatment that is given to help the original treatment keep working. You will be told if you will have maintenance therapy as well as the drugs and drug schedule you will be on.
During consolidation and/or maintenance therapy, blood (about 2 teaspoons) will be drawn for routine tests every 1-2 weeks. You will have bone marrow collected every 3-6 months to check the status of the disease.
You may have treatment on this study for up to 8 cycles (induction and consolidation therapy) or more (for maintenance therapy), depending on disease response to the study drugs. If the disease gets worse or you experience any intolerable side effects, you will be taken off this study, and your study doctor will discuss other treatment options with you.
Once your participation is over on this study, you will be followed-up with a phone call by the study doctor or study nurse to check on how you are doing and if you have experienced any intolerable side effects. The call should last about 10-15 minutes.
This is an investigational study. Idarubicin and ara-C are both FDA approved and commercially available. Up to 200 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Leukemia, Acute Myeloid Leukemia, AML
- Being tested
- Cytarabine, Idarubicin
- Keywords
- Cytarabine, Idarubicin, Leukemia, Acute Myeloid Leukemia, AML, Cytarabine, Idarubicin
- 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.
CytarabineDrug
Also called Ara-C, Cytosar-U
1.5 g/m2 IV over 24 hours daily on day 1-4 (age <60 years) or days 1-3 (age > 60 years).
IdarubicinDrug
Also called Idamycin®
12 mg/m2 IV over 1 hour daily x 3 (days 1-3)
| Study group | Role | What they receive |
|---|---|---|
| Idarubicin + Cytarabine | Experimental | Idarubicin 12 mg/m2 IV over 1 hour daily x 3 (days 1-3). Cytarabine 1.5 g/m2 IV over 24 hours daily on day 1-4 (age <60 years) or days 1-3 (age > 60 years). Receives: Drug: Cytarabine; Drug: Idarubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) Rate
Complete Response (CR): Normalization of marrow (< 5% blasts; >10% cellularity) and of peripheral blood counts (no circulating blasts, neutrophil count > 109/L, platelet count > 100 x 109/L).
Measured: Up to 2 months
Secondary outcomes (2)
Event-Free Survival (EFS)
Event -Free Survival (EFS) EFS was calculated with Kaplan-Meier estimates. Event-free survival (EFS), defined as the time to no response to intensive induction therapy, relapse, or death of any cause, whichever comes first.
Measured: from treatment initiation until treatment failure, relapse, or death
Overall Survival (OS)
Overall Survival (OS) was calculated with Kaplan-Meier estimates. OS was calculated from the time of treatment initiation until death.
Measured: Until death or loss of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2007 (estimated)
- Study startDec 2006
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Farhad Ravandi-Kashani, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422591
- Sponsor's protocol ID
- 2006-0813
- Other IDs
- NCI-2012-01412
- Status last verified
- Jul 2018
- First submitted
- 16 Jan 2007
- Last updated
- 23 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Standard Chemotherapy Regimen of Idarubicin and Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT00422591
- Acronym / sponsor ID
- 2006-0813
- Conditions
- Leukemia, Acute Myeloid Leukemia, AML
- Keywords
- Cytarabine, Idarubicin, Leukemia, Acute Myeloid Leukemia, AML, Cytarabine, Idarubicin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 17 Jan 2007 (estimated)
- Results
- Posted 12 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to find out if standard chemotherapy given with idarubicin and Cytarabine (ara-C) can help to control AML.
Objectives:
To determine the complete response (CR) rate, event-free survival (EFS) and overall survival (OS) of patients with newly diagnosed acute myeloid leukemia (AML) receiving standard combination chemotherapy with Idarubicin and cytarabine.
Detailed description
Ara-C and idarubicin are designed to interfere with DNA's (the genetic material of cells) ability to repair itself, causing cancer cells to die.
If you are found to be eligible to take part in this study, you will receive treatment with idarubicin and ara-C for up to 8 cycles. One cycle lasts about 4-5 weeks. Cycles 1 and 2 are called induction therapy, which is used to help induce (cause) a remission. Cycles 3 to 8 are called consolidation therapy, which is a type of high-dose chemotherapy often given as the second phase of a cancer treatment.
After Cycle 1, you will have a brief rest period of a few days, before you move on to Cycle 2. On Day 1 of Cycle 1, you will receive cytarabine by vein as a continuous infusion over 4 days. It will only be 3 days if you are age 60 or older. On Days 1-3 of Cycle 1, you will receive idarubicin by vein over 1 hour once a day.
The dose of the study drugs you receive may be changed to help manage side effects (such as nausea and diarrhea) that you may experience. Medications (given by mouth or by vein), such as Tylenol (acetaminophen), may be given before and during treatment to help decrease the risk of such side effects. The study doctor will specify what these medications are.
You will have blood drawn (about 2 teaspoons) for routine tests about once a week during treatment. Starting on Days 21-28, you will have bone marrow collected every 1-2 weeks to check the status of the disease. Blood (about 2 tablespoons) will also be drawn at least twice a week after each cycle of therapy (beginning about 4-6 weeks from the start of treatment each cycle) to check your blood counts.
Cycle 2 will begin after your blood counts have recovered. If at the end of Cycle 1 you have not achieved a remission (disease has decreased), you may receive Cycle 2, which will be similar to Cycle 1.
If the disease is responding to treatment after Cycle 2 (after completion of induction therapy), you will receive up to 6 more cycles of therapy. These cycles are called consolidation therapy. Consolidation therapy is a type of high-dose chemotherapy often given as the second phase to treat cancer. For consolidation therapy, you will receive ara-C as a continuous infusion over 3 days starting on Day 1 of Cycle 3. On Days 1 and 2 of Cycles 3 and 4, you will receive idarubicin by vein over 1 hour. Your blood (about 2 tablespoons) will be drawn at least twice a week after each cycle to check your blood counts. Cycle 3 will begin after your blood counts have recovered.
After completion of consolidation therapy, you may receive what is called maintenance therapy. Maintenance therapy will start after completion of consolidation therapy. Maintenance therapy is often given to help keep cancer in remission. It is treatment that is given to help the original treatment keep working. You will be told if you will have maintenance therapy as well as the drugs and drug schedule you will be on.
During consolidation and/or maintenance therapy, blood (about 2 teaspoons) will be drawn for routine tests every 1-2 weeks. You will have bone marrow collected every 3-6 months to check the status of the disease.
You may have treatment on this study for up to 8 cycles (induction and consolidation therapy) or more (for maintenance therapy), depending on disease response to the study drugs. If the disease gets worse or you experience any intolerable side effects, you will be taken off this study, and your study doctor will discuss other treatment options with you.
Once your participation is over on this study, you will be followed-up with a phone call by the study doctor or study nurse to check on how you are doing and if you have experienced any intolerable side effects. The call should last about 10-15 minutes.
This is an investigational study. Idarubicin and ara-C are both FDA approved and commercially available. Up to 200 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Idarubicin + Cytarabine | Experimental | Drug: Cytarabine, Drug: IdarubicinIdarubicin 12 mg/m2 IV over 1 hour daily x 3 (days 1-3). Cytarabine 1.5 g/m2 IV over 24 hours daily on day 1-4 (age <60 years) or days 1-3 (age > 60 years). |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of 1) AML (WHO classification definition of >/= 20% blasts). Patients with M6 AML with less than 20% blasts are eligible.
- Patients aged 15 to 75 years are eligible. Patients must be chemo-naïve, i.e. not have received any prior chemotherapy (except hydrea) for AML. They could have received transfusions, hematopoietic growth factors or vitamins. Temporary measures such as pheresis or hydrea (0.5 to 5g daily or more for up to 3 days) are allowed .
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2, or 3 at screening.
- Serum biochemical values with the following limits: - creatinine </= 2.0 mg/dl - total bilirubin </= 2.0 mg/dL, unless increase is due to hemolysis - transaminases (SG PT) </= 3x upper limit of normal (ULN)
- Ability to understand and provide signed informed consent.
Key exclusion criteria (4 listed)
- Subjects with Acute Promyelocytic Leukemia (APL).
- Presence of active systemic infection.
- Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results.
- Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, intrauterine device (IUD), diaphragm, abstinence, or condoms by their partner) over the entire course of the study.
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 |
|---|---|---|
| CytarabineAlso: Ara-C, Cytosar-U1.5 g/m2 IV over 24 hours daily on day 1-4 (age <60 years) or days 1-3 (age > 60 years). | Drug | Idarubicin + Cytarabine |
| IdarubicinAlso: Idamycin®12 mg/m2 IV over 1 hour daily x 3 (days 1-3) | Drug | Idarubicin + Cytarabine |
Primary outcome
Complete Response (CR) Rate
Time frame: Up to 2 months
Complete Response (CR): Normalization of marrow (< 5% blasts; >10% cellularity) and of peripheral blood counts (no circulating blasts, neutrophil count > 109/L, platelet count > 100 x 109/L).
2 secondary outcomes
Event-Free Survival (EFS)
Time frame: from treatment initiation until treatment failure, relapse, or death
Overall Survival (OS)
Time frame: Until death or loss of follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Farhad Ravandi-Kashani, MD principal investigator
M.D. Anderson 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 Cytarabine and Idarubicin in people with Leukemia and Acute Myeloid Leukemia, run by M.D. Anderson 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?
The sponsor lists 5 inclusion and 4 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 23 Aug 2018. 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?
Yes. Results are posted in the registry (first posted 12 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Complete Response (CR) Rate (time frame: Up to 2 months). 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 23 Aug 2018.