Acute Myelogenous LeukemiaPhase 1NCT01681537
Lenalidomide Plus Chemotherapy for AML
A Phase 1 study testing Lenalidomide, Mitoxantrone and Etoposide in people with Acute Myelogenous Leukemia, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational combination of drugs. Phase I studies also try to define the appropriate dose of the investigational combination of drugs to use for further studies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Myelogenous Leukemia
- What is being tested?
- Lenalidomide, Mitoxantrone and Etoposide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2012to Dec 2015
- Phase
- Phase 1
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary refractory disease following at least one cycle of induction therapy or first relapse or higher
- Must be registered into RevAssist program
- Able and willing to adhere to study schedule and other protocol requirements
Who cannot join
- Pregnant or breastfeeding
- Known hypersensitivity to thalidomide or lenalidomide
- Known seropositive for HIV
- Have had myocardial infarction within 6 months of enrollment or NYHA Class III or IV heart failure
- Other serious medical conditions or psychiatric conditions
- Major surgery within 28 days prior to treatment
- Received investigational agent or cytotoxic chemotherapy (except hydroxyurea) within 2 weeks of study
- Acute promyelocytic leukemia
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase I Study of Lenalidomide Plus Chemotherapy With Mitoxantrone, Etoposide, and Cytarabine for the Reinduction of Patients With Acute Myelogenous Leukemia
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational combination of drugs. Phase I studies also try to define the appropriate dose of the investigational combination of drugs to use for further studies. "Investigational" means that the combination of drugs is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved this combination of drugs for AML. As part of this research study, you will take lenalidomide in combination with MEC. MEC are FDA approved chemotherapy drugs that are commonly used in the treatment of AML. Lenalidomide is approved by the FDA for patients with multiple myeloma, and some patients with myelodysplasia. Lenalidomide is considered investigational in this research study because it is not approved by the FDA for patients with AML.
Lenalidomide is a drug that affects the immune system, called an immunomodulatory drug or IMID. This drug is successful in the treatment of patients with multiple myeloma and some patients with myelodysplasia, a pre-leukemic condition. Other research studies suggest that lenalidomide may also be effective in patients with AML. Since we know that many patients who receive MEC chemotherapy alone do not have a prolonged remission (time free from leukemia), we are studying the addition of lenalidomide to MEC.
In this research study, we are looking for the highest dose of lenalidomide that can be given safely with MEC.
Read the detailed description
After undergoing screening procedures to confirm that you are eligible to participate in the research study you will be admitted to the hospital. You will likely receive the majority of treatment on an inpatient basis. You will remain in the hospital for at least Days 4-8 and will be discharged at the discretion of your study doctor. It is likely that you will be hospitalized for several weeks due to the risk of infection after chemotherapy.
Since we are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have relapsed or refractory AML, not everyone who participates in this research study will receive the same dose of the study drug. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses.
If you take part in this study you will be given a study drug-dosing calendar. There is only one cycle of treatment, which will be 28 days long. On Days 1 to 14 you will receive the lenalidomide orally. On Days 4-8 you will receive MEC chemotherapy: mitoxantrone by IV (intravenously, into your vein) over 30 minutes, etoposide by IV over one hour, and cytarabine by IV over one hour.
While on this study you will undergo a daily clinical exam for the first 14 days and then at least twice a week until your blood counts recover from treatment. A clinical exam consists of a physical exam, questions about your general health and specific questions about any problems that you might be having and any medications you may be taking. You will also undergo blood tests to assess your disease status and determine organ function level. This will happen daily for the first 14 days and then at least once a week (but up to 3 times per week) until your blood counts recover from treatment. Additionally a bone marrow aspirate/biopsy will be completed at the time of blood cell count recovery (usually between days 20 and 45) and as clinically indicated.
We would like to keep track of your medical condition for up to two years after your final dose of study drug. We would like to do this by getting in touch with you every 6 months to see how you are doing. Keeping in touch with you and checking your condition helps us look at the long-term effects fo the research study.
- Conditions
- Acute Myelogenous Leukemia
- Being tested
- Lenalidomide, Mitoxantrone, Etoposide, Cytarabine
- Keywords
- Relapsed, Refractory
- Medical subject headings
- Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
MitoxantroneDrug
EtoposideDrug
CytarabineDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Lenalidomide and re-induction chemotherapy Receives: Drug: Lenalidomide; Drug: Mitoxantrone; Drug: Etoposide; Drug: Cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of lenalidomide plus conventional chemotherapy for relapsed AML
Evaluation of the safety of lenalidomide in combination with conventional chemotherapy for relapsed acute myelogenous leukemia. Dose limiting toxicity is defined as a Grade IV rash or delayed neutrophil or platelet recovery beyond Day 45 after start of chemotherapy in the absence of disease
Measured: 2 years
Secondary outcomes (4)
Days to neutrophil recovery
Evaluation of neutrophil recovery (the first 3 days of ANC>500)
Measured: 2 years
Complete Remission Rate
Evaluation of the complete remission rate and the complete remission rate without platelet recovery
Measured: 2 years
Treatment-related mortality
Evaluation of the treatment-related mortality, the number of non-relapse related deaths in the first 45 days of starting treatment
Measured: 2 years
Transfusion Support
Evaluation of transfusion support, the number of red blood cell and platelet transfusions needed in the first 45 days of treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myelogenous LeukemiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Ballen, Massachusetts General Hospital
- Investigators
- Karen Ballen, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681537
- Sponsor's protocol ID
- 12-202
- Status last verified
- Mar 2016
- First submitted
- 2 Sep 2012
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Lenalidomide Plus Chemotherapy With Mitoxantrone, Etoposide, and Cytarabine for the Reinduction of Patients With Acute Myelogenous Leukemia
- ClinicalTrials.gov ID
- NCT01681537
- Acronym / sponsor ID
- 12-202
- Conditions
- Acute Myelogenous Leukemia
- Keywords
- Relapsed, Refractory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Sep 2012 (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.
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational combination of drugs. Phase I studies also try to define the appropriate dose of the investigational combination of drugs to use for further studies. "Investigational" means that the combination of drugs is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved this combination of drugs for AML. As part of this research study, you will take lenalidomide in combination with MEC. MEC are FDA approved chemotherapy drugs that are commonly used in the treatment of AML. Lenalidomide is approved by the FDA for patients with multiple myeloma, and some patients with myelodysplasia. Lenalidomide is considered investigational in this research study because it is not approved by the FDA for patients with AML.
Lenalidomide is a drug that affects the immune system, called an immunomodulatory drug or IMID. This drug is successful in the treatment of patients with multiple myeloma and some patients with myelodysplasia, a pre-leukemic condition. Other research studies suggest that lenalidomide may also be effective in patients with AML. Since we know that many patients who receive MEC chemotherapy alone do not have a prolonged remission (time free from leukemia), we are studying the addition of lenalidomide to MEC.
In this research study, we are looking for the highest dose of lenalidomide that can be given safely with MEC.
Detailed description
After undergoing screening procedures to confirm that you are eligible to participate in the research study you will be admitted to the hospital. You will likely receive the majority of treatment on an inpatient basis. You will remain in the hospital for at least Days 4-8 and will be discharged at the discretion of your study doctor. It is likely that you will be hospitalized for several weeks due to the risk of infection after chemotherapy.
Since we are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have relapsed or refractory AML, not everyone who participates in this research study will receive the same dose of the study drug. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses.
If you take part in this study you will be given a study drug-dosing calendar. There is only one cycle of treatment, which will be 28 days long. On Days 1 to 14 you will receive the lenalidomide orally. On Days 4-8 you will receive MEC chemotherapy: mitoxantrone by IV (intravenously, into your vein) over 30 minutes, etoposide by IV over one hour, and cytarabine by IV over one hour.
While on this study you will undergo a daily clinical exam for the first 14 days and then at least twice a week until your blood counts recover from treatment. A clinical exam consists of a physical exam, questions about your general health and specific questions about any problems that you might be having and any medications you may be taking. You will also undergo blood tests to assess your disease status and determine organ function level. This will happen daily for the first 14 days and then at least once a week (but up to 3 times per week) until your blood counts recover from treatment. Additionally a bone marrow aspirate/biopsy will be completed at the time of blood cell count recovery (usually between days 20 and 45) and as clinically indicated.
We would like to keep track of your medical condition for up to two years after your final dose of study drug. We would like to do this by getting in touch with you every 6 months to see how you are doing. Keeping in touch with you and checking your condition helps us look at the long-term effects fo the research study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Lenalidomide, Drug: Mitoxantrone, Drug: Etoposide, Drug: CytarabineLenalidomide and re-induction chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary refractory disease following at least one cycle of induction therapy or first relapse or higher
- Must be registered into RevAssist program
- Able and willing to adhere to study schedule and other protocol requirements
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding
- Known hypersensitivity to thalidomide or lenalidomide
- Known seropositive for HIV
- Have had myocardial infarction within 6 months of enrollment or NYHA Class III or IV heart failure
- Other serious medical conditions or psychiatric conditions
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 |
|---|---|---|
| Lenalidomide | Drug | Treatment Arm |
| Mitoxantrone | Drug | Treatment Arm |
| Etoposide | Drug | Treatment Arm |
| Cytarabine | Drug | Treatment Arm |
Primary outcome
Safety of lenalidomide plus conventional chemotherapy for relapsed AML
Time frame: 2 years
Evaluation of the safety of lenalidomide in combination with conventional chemotherapy for relapsed acute myelogenous leukemia. Dose limiting toxicity is defined as a Grade IV rash or delayed neutrophil or platelet recovery beyond Day 45 after start of chemotherapy in the absence of disease
4 secondary outcomes
Days to neutrophil recovery
Time frame: 2 years
Complete Remission Rate
Time frame: 2 years
Treatment-related mortality
Time frame: 2 years
Transfusion Support
Time frame: 2 years
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 17 Mar 2016.
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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.
Karen Ballen, MD principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lenalidomide, Mitoxantrone and Etoposide in people with Acute Myelogenous Leukemia, run by Massachusetts General Hospital at 3 sites 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 3 inclusion and 8 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 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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.
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?
Safety of lenalidomide plus conventional chemotherapy for relapsed AML (time frame: 2 years). 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 17 Mar 2016.