Lenalidomide Plus Chemotherapy for AML
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | September 2012 |
| End Date: | December 2015 |
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.
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.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
3
sites
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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