Mitoxantrone, Etoposide, and Cytarabine (MEC) Plus Lenalidomide for Relapsed or Refractory Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT03118466|
Recruitment Status : Active, not recruiting
First Posted : April 18, 2017
Results First Posted : February 3, 2021
Last Update Posted : February 3, 2021
|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)|
|Actual Enrollment :||41 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|
|Actual Primary Completion Date :||August 29, 2019|
|Estimated Study Completion Date :||August 2021|
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 achieve CR or CRp after treatment.
- Morphologic Complete Remission (CR): Defined as morphologic leukemia-free state, including <5% blasts in Bone Marrow aspirate with marrow spicules, no persistent extramedullary disease, ANC >1000/mm3 and platelet count >100,000/mm3.
- Morphologic Complete Remission without platelet recovery (CRp): Defined as CR with the exception of platelet count < 100,000/mm3 (CRp).
- Number of Patients That Achieved ANC Recovery [ Time Frame: up to 45 days ]The number of patients that achieved a neutrophil count of > 500/mm3 for 3 days within 45 of starting treatment
- Number of Patients That Achieved Platelet Recovery [ Time Frame: up to 45 days ]The number of patients that achieved a stable platelet count > 20,000/mm3 for 3 days within 45 days of starting treatment
- Treatment-related Mortality [ Time Frame: 50 days ]Cumulative number of deaths not related to persistent or relapsed leukemia during treatment within 50 days of the start of treatment.
- Transfusion Support: Number of Red Blood Cell and Platelet Transfusions [ Time Frame: 50 days ]Number of red blood cell and platelet transfusions received within the first 50 days of treatment
- Overall Survival [ Time Frame: Up to 3 years ]Overall survival is defined as time from diagnosis of disease until date of death or censored on the last known date alive if patients are still alive.
- Relapse-Free Survival [ Time Frame: Up to 3 years ]Relapse-Free Survival is defined as time from diagnosis of disease until date of relapse, death, or censored on the last known date alive if patients are still alive.Relapse is defined by morphological evidence of the original malignancy consistent with pre-treatment features.
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
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02062|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Massachusetts general Hospital|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Andrew Brunner, MD||Massachusetts General Hospital|