Lenalidomide Plus Chemotherapy for AML

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Karen Ballen, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01681537
First received: September 2, 2012
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Acute Myelogenous Leukemia
Drug: Lenalidomide
Drug: Mitoxantrone
Drug: Etoposide
Drug: Cytarabine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Lenalidomide Plus Chemotherapy With Mitoxantrone, Etoposide, and Cytarabine for the Reinduction of Patients With Acute Myelogenous Leukemia

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Safety of lenalidomide plus conventional chemotherapy for relapsed AML [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Days to neutrophil recovery [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Evaluation of neutrophil recovery (the first 3 days of ANC>500)

  • Complete Remission Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Evaluation of the complete remission rate and the complete remission rate without platelet recovery

  • Treatment-related mortality [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Evaluation of the treatment-related mortality, the number of non-relapse related deaths in the first 45 days of starting treatment

  • Transfusion Support [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Evaluation of transfusion support, the number of red blood cell and platelet transfusions needed in the first 45 days of treatment


Estimated Enrollment: 28
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm
Lenalidomide and re-induction chemotherapy
Drug: Lenalidomide Drug: Mitoxantrone Drug: Etoposide Drug: Cytarabine

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681537

Contacts
Contact: Karen Ballen, MD 6177241124 kballen@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Richard Stone, MD    617-632-2214    rstone@partners.org   
Principal Investigator: Richard Stone, MD         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Richard Stone, MD    617-632-2214    rstone@partners.org   
Principal Investigator: Richard Stone, MD         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Karen Ballen, MD    617-724-1124    kballen@partners.org   
Principal Investigator: Karen Ballen, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Karen Ballen, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Karen Ballen, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01681537     History of Changes
Other Study ID Numbers: 12-202
Study First Received: September 2, 2012
Last Updated: September 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Relapsed
Refractory

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type
Cytarabine
Etoposide
Lenalidomide
Mitoxantrone
Thalidomide
Analgesics
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Central Nervous System Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 23, 2014