LeukemiaPhase 2NCT01692197
E7070, Idarubicin and Cytarabine in Relapsed AML and High-Risk Myelodysplastic Syndromes
A Phase 2 study testing E7070, Idarubicin and Cytarabine in people with 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 learn if E7070 in combination with idarubicin, cytarabine, and dexamethasone can help to control the disease in patients with either AML or high-risk MDS that has relapsed. The safety of the drug combination will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- E7070, Idarubicin and Cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2013to 7 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with histologically or cytologically confirmed relapsed or refractory acute myeloid leukemia (AML) [except acute promyelocytic leukemia], or high-risk myelodysplastic syndrome (HRMDS) (Int-2 high risk by International Prostate Symptom Score (IPSS) or >10% blasts in marrow).
- Patients must be 18 years or older.
- Patients must have a performance status of 0-2 (Zubrod scale).
- Patients must have adequate renal function (serum creatinine less than or equal to 1.3 mg/dL and/or creatinine clearance > 40 mL/min). Patients with renal dysfunction due to organ infiltration by disease may be eligible after discussion with the Principal Investigator (PI) (up to creatinine less than or equal to 2.0), and appropriate dose adjustments will be considered.
- Patients must have adequate hepatic function (bilirubin less than or equal to 2.0 mg/dl; SGOT or Serum glutamic pyruvic transaminase (SGPT) less than or equal to 3 times the ULN for the reference lab unless due to leukemia or congenital hemolytic disorder or bilirubin). Patients with hepatic dysfunction (SGOT/SGPT up to less than or equal to 5 X ULN) due to organ infiltration by disease may be eligible after discussion with the PI, and appropriate dose adjustments will be considered.
- Patients must have normal cardiac ejection fraction
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- QTc interval </= 480 msecs.
- Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
- Female patients must not be pregnant or lactating. Female patients of childbearing potential (including those <1 year post-menopausal) and male patients must agree to use contraception.
Who cannot join
- Patients must not have untreated or uncontrolled life-threatening infection.
- Patients must not have received chemotherapy and/or radiation therapy within 2 weeks. Hydroxyurea is allowed up to 48 hours prior to starting therapy in the setting of rapidly proliferating disease. Use of hydroxyurea to control proliferative disease will be allowed starting from day 2 until day 7 Cycle 1. Maximum dose of hydroxyurea allowed daily is 5 gram and hydroxyurea must be discontinued once administration of idarubicin and cytarabine is started.
- Any other medical condition, including mental illness or substance abuse, deemed by the PI to be likely to interfere with a patient's ability to sign informed consent or cooperate and participate in the study or with the interpretation of the results.
- Patients must not have received an investigational anti-cancer drug within two weeks of E7070 administration.
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: A Phase 2 Study of E7070, Idarubicin and Cytarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia and High-risk Myelodysplastic Syndromes
The goal of this clinical research study is to learn if E7070 in combination with idarubicin, cytarabine, and dexamethasone can help to control the disease in patients with either AML or high-risk MDS that has relapsed. The safety of the drug combination will also be studied.
Read the detailed description
The Study Drugs:
E7070 is designed to stop metabolic ingredients from reaching the cancer cells and to stop the cancer cell from dividing.
Cytarabine is designed to insert itself into DNA (the genetic material of cells) of cancer cells and stop the DNA from repairing itself.
Idarubicin is designed to cause breaks in both strands of DNA (the genetic material of cells).
Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body. Dexamethasone is often given to AML patients in combination with other chemotherapy to treat cancer.
Study Drug Administration:
If you are found eligible to take part in this study, you will receive E7070 by vein over 1 hour on Day 1 and Day 8 (+/- 2 days on Day 8 only) followed by idarubicin by vein over 1 hour on Days 9-11. You will also receive cytarabine by vein over 24 hours each day on Days 9-12. If you are 60 years of age or older, you will only receive cytarabine on Days 9-11. On days that you are receiving the cytarabine infusions, you will also receive dexamethasone by vein over about 30 minutes. You will receive dexamethasone before the cytarabine infusions. Each study cycle is about 28 days.
If your doctor thinks you are benefitting from taking the E7070 in combination with idarubicin, cytarabine, and dexamethasone, you may receive up to 2 additional cycles of the study drug combination.
Study Visits:
During Cycle 1, the following tests and procedures will be performed:
- You will be asked about medications you are taking and side effects you may have had.
- Blood (about 2 teaspoons) will be drawn at least 1 time every week for routine tests and to check your liver and kidney function.
- You will have a bone marrow aspirate on Day 28 (+/- 3 days) to check the status of the disease. You may have additional bone marrow aspirates during Cycle 2 if the doctor thinks it is necessary.
- During Cycle 1 only, you will have an ECG on Day 2 (+/- 1 day) and Day 8 (+/- 2 days).
Treatment cycles beyond Cycle 1, the following tests and procedures will be performed:
- You will be asked about medications you are taking and side effects you may have had.
- Blood (about 2 teaspoons) will be drawn every 2-4 weeks for routine tests.
- You will have a bone marrow aspirate to check the status of the disease whenever the doctor feels it is necessary.
Length of Study:
If the doctor thinks you are benefitting with E7070 in combination with idarubicin, cytarabine and dexamethasone, you may receive 2 additional cycles of therapy (a total of 3 cycles on this study.)
You will be taken off study if the disease gets worse, you experience intolerable side effects, or if the study doctor thinks it is in your best interest.
End-of-Treatment Visit:
At the end of treatment, blood (about 2 teaspoons) will be drawn for routine tests within 30 days (+/- 5 days) of your last dose of the study drug combination. You will also be asked about any side effects you may have had.
Long Term Follow-up (unless you have started on alternative therapy):
Blood (about 1 tablespoon) will be drawn for routine tests every 2-3 months for up to 2 years unless the disease gets worse or you start on another treatment.
This is an investigational study. E7070 is not FDA-approved or commercially available for use in patients with AML or MDS that has relapsed. Its use in this study is considered investigational. Idarubicin, cytarabine, and dexamethasone are FDA-approved and commercially available for use in the treatment of AML. The combination of E7070, idarubicin, cytarabine, and dexamethasone in this study is investigational.
Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Leukemia
- Being tested
- E7070, Idarubicin, Cytarabine, Dexamethasone
- Keywords
- Leukemia, Acute Myeloid Leukemia, Acute Myelogenous Leukemia, AML, Relapsed or Refractory, High-Risk Myelodysplastic Syndromes, HRMDS, E7070, Idarubicin, Idamycin, Cytarabine, Cytarabine (ARA-C), Cytosar, DepoCyt, Cytosine Arabinosine Hydrochloride, Dexamethasone, Decadron
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E7070Drug
400 mg/m2 intravenously over 1 hour on Day 1 and Day 8 every 3 weeks.
IdarubicinDrug
Also called Idamycin
8 mg/m2 by vein over 1 hour daily for 3 days (Days 9-11).
CytarabineDrug
Also called ARA-C, Cytosar, DepoCyt, Cytosine Arabinosine Hydrochloride
1.0 g/m2 by vein daily on Days 9 - 12 (age <60 years) or Days 9 - 11 (age > 60 years).
DexamethasoneDrug
Also called Decadron
10 mg by vein daily for 3 - 4 days with cytarabine.
| Study group | Role | What they receive |
|---|---|---|
| E7070 + Idarubicin + Cytarabine | Experimental | E7070 400 mg/m2 IV over 1 hour on day 1 and day 8 (+/- 2 days on Day 8 only) followed by, Idarubicin 8 mg/m2 IV over 1 hour daily for 3 days (days 9-11) and Cytarabine 1.0 g/m2 IV over 24 hours daily on day 9-12 (age <60 years) or days 9-11 (age > 60 years). Dexamethasone 10 mg IV daily for 3-4 days with cytarabine. Receives: Drug: E7070; Drug: Idarubicin; Drug: Cytarabine; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response
Efficacy measured by overall response - complete response plus complete response with incomplete platelet recovery, plus partial response (Complete remission (CR) + Complete remission without platelet recovery (CRp) + Partial Remission (PR)+ marrow clearance of blast) during cycle 1.
Measured: 2 cycles (60 days)
Secondary outcomes (3)
Disease-free Survival
Time from date of treatment start until the date of first objective documentation of disease-relapse.
Measured: Up to 5 years
Duration of Response
Response date to loss of response or last follow up.
Measured: Up to 5 years
Overall Survival
Time from date of treatment start until date of death due to any cause or last follow-up.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study start1 Feb 2013
- Primary completion7 Jun 2017
- Study completion7 Jun 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Responsible party
- Sponsor
- Investigators
- Gautam Borthakur, MBBS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692197
- Sponsor's protocol ID
- 2009-0570
- Other IDs
- NCI-2012-02065
- Status last verified
- Jun 2018
- First submitted
- 20 Sep 2012
- Last updated
- 3 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of E7070, Idarubicin and Cytarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia and High-risk Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT01692197
- Acronym / sponsor ID
- 2009-0570
- Conditions
- Leukemia
- Keywords
- Leukemia, Acute Myeloid Leukemia, Acute Myelogenous Leukemia, AML, Relapsed or Refractory, High-Risk Myelodysplastic Syndromes, HRMDS, E7070
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 7 Jun 2017 (actual)
- Study completion
- 7 Jun 2017 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Posted 3 Jul 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 learn if E7070 in combination with idarubicin, cytarabine, and dexamethasone can help to control the disease in patients with either AML or high-risk MDS that has relapsed. The safety of the drug combination will also be studied.
Detailed description
The Study Drugs:
E7070 is designed to stop metabolic ingredients from reaching the cancer cells and to stop the cancer cell from dividing.
Cytarabine is designed to insert itself into DNA (the genetic material of cells) of cancer cells and stop the DNA from repairing itself.
Idarubicin is designed to cause breaks in both strands of DNA (the genetic material of cells).
Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body. Dexamethasone is often given to AML patients in combination with other chemotherapy to treat cancer.
Study Drug Administration:
If you are found eligible to take part in this study, you will receive E7070 by vein over 1 hour on Day 1 and Day 8 (+/- 2 days on Day 8 only) followed by idarubicin by vein over 1 hour on Days 9-11. You will also receive cytarabine by vein over 24 hours each day on Days 9-12. If you are 60 years of age or older, you will only receive cytarabine on Days 9-11. On days that you are receiving the cytarabine infusions, you will also receive dexamethasone by vein over about 30 minutes. You will receive dexamethasone before the cytarabine infusions. Each study cycle is about 28 days.
If your doctor thinks you are benefitting from taking the E7070 in combination with idarubicin, cytarabine, and dexamethasone, you may receive up to 2 additional cycles of the study drug combination.
Study Visits:
During Cycle 1, the following tests and procedures will be performed:
- You will be asked about medications you are taking and side effects you may have had.
- Blood (about 2 teaspoons) will be drawn at least 1 time every week for routine tests and to check your liver and kidney function.
- You will have a bone marrow aspirate on Day 28 (+/- 3 days) to check the status of the disease. You may have additional bone marrow aspirates during Cycle 2 if the doctor thinks it is necessary.
- During Cycle 1 only, you will have an ECG on Day 2 (+/- 1 day) and Day 8 (+/- 2 days).
Treatment cycles beyond Cycle 1, the following tests and procedures will be performed:
- You will be asked about medications you are taking and side effects you may have had.
- Blood (about 2 teaspoons) will be drawn every 2-4 weeks for routine tests.
- You will have a bone marrow aspirate to check the status of the disease whenever the doctor feels it is necessary.
Length of Study:
If the doctor thinks you are benefitting with E7070 in combination with idarubicin, cytarabine and dexamethasone, you may receive 2 additional cycles of therapy (a total of 3 cycles on this study.)
You will be taken off study if the disease gets worse, you experience intolerable side effects, or if the study doctor thinks it is in your best interest.
End-of-Treatment Visit:
At the end of treatment, blood (about 2 teaspoons) will be drawn for routine tests within 30 days (+/- 5 days) of your last dose of the study drug combination. You will also be asked about any side effects you may have had.
Long Term Follow-up (unless you have started on alternative therapy):
Blood (about 1 tablespoon) will be drawn for routine tests every 2-3 months for up to 2 years unless the disease gets worse or you start on another treatment.
This is an investigational study. E7070 is not FDA-approved or commercially available for use in patients with AML or MDS that has relapsed. Its use in this study is considered investigational. Idarubicin, cytarabine, and dexamethasone are FDA-approved and commercially available for use in the treatment of AML. The combination of E7070, idarubicin, cytarabine, and dexamethasone in this study is investigational.
Up to 40 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 |
|---|---|---|
| E7070 + Idarubicin + Cytarabine | Experimental | Drug: E7070, Drug: Idarubicin, Drug: Cytarabine, Drug: DexamethasoneE7070 400 mg/m2 IV over 1 hour on day 1 and day 8 (+/- 2 days on Day 8 only) followed by, Idarubicin 8 mg/m2 IV over 1 hour daily for 3 days (days 9-11) and Cytarabine 1.0 g/m2 IV over 24 hours daily on day 9-12 (age <60 years) or days 9-11 (age > 60 years). Dexamethasone 10 mg IV daily for 3-4 days with cytarabine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All patients with histologically or cytologically confirmed relapsed or refractory acute myeloid leukemia (AML) [except acute promyelocytic leukemia], or high-risk myelodysplastic syndrome (HRMDS) (Int-2 high risk by International Prostate Symptom Score (IPSS) or >10% blasts in marrow).
- Patients must be 18 years or older.
- Patients must have a performance status of 0-2 (Zubrod scale).
- Patients must have adequate renal function (serum creatinine less than or equal to 1.3 mg/dL and/or creatinine clearance > 40 mL/min). Patients with renal dysfunction due to organ infiltration by disease may be eligible after discussion with the Principal Investigator (PI) (up to creatinine less than or equal to 2.0), and appropriate dose adjustments will be considered.
- Patients must have adequate hepatic function (bilirubin less than or equal to 2.0 mg/dl; SGOT or Serum glutamic pyruvic transaminase (SGPT) less than or equal to 3 times the ULN for the reference lab unless due to leukemia or congenital hemolytic disorder or bilirubin). Patients with hepatic dysfunction (SGOT/SGPT up to less than or equal to 5 X ULN) due to organ infiltration by disease may be eligible after discussion with the PI, and appropriate dose adjustments will be considered.
Key exclusion criteria (4 listed)
- Patients must not have untreated or uncontrolled life-threatening infection.
- Patients must not have received chemotherapy and/or radiation therapy within 2 weeks. Hydroxyurea is allowed up to 48 hours prior to starting therapy in the setting of rapidly proliferating disease. Use of hydroxyurea to control proliferative disease will be allowed starting from day 2 until day 7 Cycle 1. Maximum dose of hydroxyurea allowed daily is 5 gram and hydroxyurea must be discontinued once administration of idarubicin and cytarabine is started.
- Any other medical condition, including mental illness or substance abuse, deemed by the PI to be likely to interfere with a patient's ability to sign informed consent or cooperate and participate in the study or with the interpretation of the results.
- Patients must not have received an investigational anti-cancer drug within two weeks of E7070 administration.
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 |
|---|---|---|
| E7070400 mg/m2 intravenously over 1 hour on Day 1 and Day 8 every 3 weeks. | Drug | E7070 + Idarubicin + Cytarabine |
| IdarubicinAlso: Idamycin8 mg/m2 by vein over 1 hour daily for 3 days (Days 9-11). | Drug | E7070 + Idarubicin + Cytarabine |
| CytarabineAlso: ARA-C, Cytosar, DepoCyt, Cytosine Arabinosine Hydrochloride1.0 g/m2 by vein daily on Days 9 - 12 (age <60 years) or Days 9 - 11 (age > 60 years). | Drug | E7070 + Idarubicin + Cytarabine |
| DexamethasoneAlso: Decadron10 mg by vein daily for 3 - 4 days with cytarabine. | Drug | E7070 + Idarubicin + Cytarabine |
Primary outcome
Overall Response
Time frame: 2 cycles (60 days)
Efficacy measured by overall response - complete response plus complete response with incomplete platelet recovery, plus partial response (Complete remission (CR) + Complete remission without platelet recovery (CRp) + Partial Remission (PR)+ marrow clearance of blast) during cycle 1.
3 secondary outcomes
Disease-free Survival
Time frame: Up to 5 years
Duration of Response
Time frame: Up to 5 years
Overall Survival
Time frame: Up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 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.
Gautam Borthakur, MBBS 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 E7070, Idarubicin and Cytarabine in people with 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 9 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 3 Jul 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 3 Jul 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?
Overall Response (time frame: 2 cycles (60 days)). 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 3 Jul 2018.