Mitoxantrone, Etoposide, and Cytarabine (MEC) Plus Lenalidomide for Relapsed or Refractory Acute Myeloid Leukemia

NCT03118466 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 16-574
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 3

Brief Summary

This research study is evaluating how a drug called lenalidomide, given in combination with the standard chemotherapy regimen of Mitoxantrone, Etoposide, and Cytarabine, commonly referred to as MEC, works in individuals with either relapsed or refractory AML

Conditions

AML

Keywords

AML

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate

  Percentage 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).

  up to 45 days

Secondary Outcomes (6)

• Number of Patients That Achieved ANC Recovery

  up to 45 days

• Number of Patients That Achieved Platelet Recovery

  up to 45 days

• Treatment-related Mortality

  50 days

• Transfusion Support: Number of Red Blood Cell and Platelet Transfusions

  50 days

• Overall Survival

  Up to 3 years

Study Arms (1)

Lenalidomide and MEC chemotherapy

EXPERIMENTAL

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.

Drug: Etoposide; Drug: Cytarabine; Drug: Lenalidomide; Drug: Mitoxantrone

Interventions

Etoposide DRUG

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.

Also known as: Toposar

Lenalidomide and MEC chemotherapy

Cytarabine DRUG

Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA.

Also known as: Depocyt

Lenalidomide and MEC chemotherapy

Lenalidomide DRUG

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

Also known as: REVLIMID

Lenalidomide and MEC chemotherapy

Mitoxantrone DRUG

It interfere with cell reproduction

Also known as: Novantrone

Lenalidomide and MEC chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute myelogenous leukemia diagnosed by WHO criteria with one of the following (patients with biphenotypic leukemia are eligible, provided that the treating physician determines an AML treatment regimen is appropriate)
• Primary refractory disease following \> 1cycle of chemotherapy, (such as hypomethylating agent or induction chemotherapy)
• First relapse or higher. Patients with primary or secondary acute myelogenous leukemia are eligible.
• Age 18-70 years old
• LVEF \> 50 %
• ECOG Performance status 0-2
• Able to adhere to study schedule and other protocol requirements.
• Participants must have normal organ function as defined below, unless felt due to underlying disease and approved by the overall PI. Patients with Gilbert's disease may have total bilirubin up to \< 3 x ULN.
• Creatinine \< 2.0mg/dl
• Total bilirubin \< 1.5 x ULN
• AST (SGOT) and ALT (SGPT) \< 3 x ULN.
• Patients may receive hydroxyurea, steroids, or leukapheresis as necessary until Day 5 of treatment.
• Patients must give voluntary written informed consent and HIPAA authorization before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
• Patients may have had prior treatment for MDS or AML, including prior lenalidomide for MDS or AML or another condition.
• Patient may have had prior autologous or allogeneic transplant (family member, unrelated donor, or cord blood) if there is at least 90 days between transplant and study entry.

You may not qualify if:

• Known hypersensitivity to thalidomide or lenalidomide (if applicable).
• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
• Known seropositive for human immunodeficiency virus (HIV). HIV testing is not required. Hepatitis testing is not required.
• Patients who have had a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
• Any serious medical condition laboratory abnormality or psychiatric illness that would prevent the subject from signing the consent form.
• Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
• Patients with major surgery within 28 days prior to treatment.
• Patients with any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
• Patient has received an investigational agent or cytotoxic chemotherapy (excluding hydroxyurea) within 7 days of study entry.
• Patients with acute promyelocytic leukemia.
• Females who are pregnant

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Celgene: collaborator

Study Sites (3)

Dana Farber Cancer Institute

Boston, Massachusetts, 02062, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Massachusetts general Hospital

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Interventions

Etoposide; Cytarabine; Lenalidomide; Mitoxantrone

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Anthraquinones; Anthrones; Anthracenes; Quinones

Results Point of Contact

• Title: Andrew Brunner MD
• Organization: Massachusetts General Hospital

abrunner@mgh.harvard.edu

6177241124

Study Officials

• Andrew Brunner, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 18, 2017
• Study Start: September 25, 2017
• Primary Completion: August 29, 2019
• Study Completion: August 18, 2021
• Last Updated: October 15, 2025
• Results First Posted: February 3, 2021

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)