Lenalidomide Plus Chemotherapy for AML

NCT01681537 | Completed Phase 1 DMC

• 1 other identifier: 12-202
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Acute Myelogenous Leukemia

Keywords

Relapsed; Refractory

Outcome Measures

Primary Outcomes (1)

• Safety of lenalidomide plus conventional chemotherapy for relapsed AML

  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

  2 years

Secondary Outcomes (4)

• Days to neutrophil recovery

  2 years

• Complete Remission Rate

  2 years

• Treatment-related mortality

  2 years

• Transfusion Support

  2 years

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Lenalidomide and re-induction chemotherapy

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

Interventions

Lenalidomide DRUG

Treatment Arm

Mitoxantrone DRUG

Treatment Arm

Etoposide DRUG

Treatment Arm

Cytarabine DRUG

Treatment Arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Recurrence

Interventions

Lenalidomide; Mitoxantrone; Etoposide; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Karen Ballen, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: September 2, 2012
• First Posted: September 10, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 17, 2016

Record last verified: 2016-03

Locations

US (3)