Mitoxantrone, Etoposide, and Cytarabine (MEC) Plus Lenalidomide for Relapsed or Refractory Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT03118466|
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : June 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|AML||Drug: Etoposide Drug: Cytarabine Drug: Lenalidomide Drug: Mitoxantrone||Phase 2|
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved lenalidomide for this specific disease, but it has been approved for other uses, including for patients with multiple myeloma and some patients with myelodysplastic syndrome. This treatment is investigational because it is not approved by the FDA for patients with AML. Lenalidomide is a chemotherapy that also modulates the immune system, and is in a category of drugs called immunomodulatory drugs or IMIDs. Some research studies suggest that lenalidomide may be effective in patients with AML. Since the investigators know that many patients who receive MEC chemotherapy alone have less than desired response rates and overall shorter periods of remission (time free from leukemia) after treatment, the investigators are studying whether the addition of lenalidomide to MEC improves upon typical responses.
The combination of MEC (mitoxantrone, etoposide, and cytarabine) is a standard treatment option, commonly used for relapsed or refractory acute myeloid leukemia.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of Mitoxantrone, Etoposide, and Cytarabine (MEC) Plus Lenalidomide for the Treatment of Adult Patients With Relapsed or Refractory Acute Myeloid Leukemia|
|Actual Study Start Date :||September 25, 2017|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2024|
Experimental: Lenalidomide and MEC chemotherapy
Lenalidomide is taken orally on a daily basis days 1-10. Mitoxantrone, Etoposide, and Cytarabine are administered intravenously on a daily basis for days 4 through 8 of the treatment. There is only one cycle of treatment in this study.
A Drug that interfere with the action of topoisomerase enzymes (topoisomerase I and II). Topoisomerase enzymes control the manipulation of the structure of DNA necessary for replication.
Other Name: Toposar
Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA.
Other Name: Depocyt
It may act by inhibiting the growth of new blood vessels (angiogenesis) in tumors, enhancing the status of the immune system, or decreasing cytokine and growth factor production
Other Name: REVLIMID
It interfere with cell reproduction
Other Name: Novantrone
- Complete Response Rate [ Time Frame: up to 45 days ]Proportion of patients who have no apparent leukemia and have normal blood counts after treatment
- Days to ANC recovery [ Time Frame: up to 45 days ]Time from the first day of chemotherapy to the first day where the neutrophil count is > 500 for 3 days
- Days of platelet recovery [ Time Frame: up to 45 days ]Time from the first day of chemotherapy to the first day where the platelet count is stable > 20 for 3 days
- Treatment-related mortality [ Time Frame: 50 days ]Cumulative number of deaths not related to persistent or relapsed leukemia during treatment
- Transfusion support: Number of red blood cell and platelet transfusions [ Time Frame: 45 days ]Number of red blood cell and platelet transfusions
- Explore Associations Between Somatic Mutations and CR [ Time Frame: Up to 45 days ]The proportion of patients achieving remission according to mutation status
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118466
|Contact: Andrew Brunner, MD||617-724-1124||Andrew_Brunner@DFCI.HARVARD.EDU|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02062|
|Contact: Richard Stone, MD 617-632-2214 Richard_Stone@dfci.harvard.edu|
|Principal Investigator: Richard Stone, MD|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Lourdes Mendez, MD 617-667-9920|
|Principal Investigator: Lourdes Mendez, MD|
|Massachusetts general Hospital||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Andrew Brunner, MD 617-724-1124 Andrew_Brunner@DFCI.HARVARD.EDU|
|Principal Investigator: Andrew Brunner, MD|
|Principal Investigator:||Andrew Brunner, MD||Massachusetts General Hospital|