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A Phase I Study of Lenalidomide Plus Chemotherapy With Mitoxantrone, Etoposide, and Cytarabine for the Reinduction of Patients With Acute Myelogenous Leukemia

Phase 1
18 Years
70 Years
Open (Enrolling)
Acute Myelogenous Leukemia

Thank you

Trial Information

A Phase I Study of Lenalidomide Plus Chemotherapy With Mitoxantrone, Etoposide, and Cytarabine for the Reinduction of Patients With Acute Myelogenous Leukemia

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.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of lenalidomide plus conventional chemotherapy for relapsed AML

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Karen Ballen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

September 2012

Completion Date:

December 2014

Related Keywords:

  • Acute Myelogenous Leukemia
  • Relapsed
  • Refractory
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Brigham and Women's HospitalBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617