Study of Lenalidomide in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome

NCT01433965 | Completed Phase 1 DMC

• 2 other identifiers: 230510UCDCC#227
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether lenalidomide can stop the growth of leukemia stem cells and can be used to prevent the return of leukemia cells after a transplant.

Conditions

Acute Myeloid Leukemia; Myelodysplastic Syndrome

Keywords

Bone marrow transplantation; Maintenance lenalidomide

Outcome Measures

Primary Outcomes (1)

• Maximum-tolerated dose as assessed by NCI CTCAE, Version 4.0 and Graft versus Host Disease Staging

  All patients will be followed closely and evaluated for toxicity. For grade III-IV non hematological toxicity or grade IV hematological toxicity associated with lenalidomide will be held until the toxicity resolves and then will be started at a lower dose; Patients who develop grade II to IV GVHD on study will stop lenalidomide

  4 week cycle; the expected time frame is 24 weeks (or 6 cycles)

Secondary Outcomes (3)

• Disease relapse

  One year

• Disease-free survival

  One year

• Incidence of Graft versus Host disease

  One year

Study Arms (1)

Phase I Dose Escalation

EXPERIMENTAL

Subjects are given a single dose of the drug while they are observed and tested for a period of time. If they do not exhibit any adverse side effects the dose is escalated, and a new group of subjects is then given a higher dose.

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

Lenalidomide will be taken orally once a day for 21 days continuously in 28 day cycles. The dose of the lenalidomide administered to each patient will be based on the group that the patient is enrolled. The dose cycles will be 21 days of a 28 day cycle.

Also known as: REVLIMID, CC-5013

Phase I Dose Escalation

Eligibility Criteria

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

You may qualify if:

• Understand and voluntarily sign an informed consent form
• Age greater than or equal to 18 and less than or equal to 65 years
• Able to adhere to the study visit schedule and other protocol requirements.
• High risk acute myelogenous leukemia or high risk myelodysplastic syndrome status post allogeneic bone marrow transplant
• ECOG performance status of less than or equal to 2
• Disease free of other malignancies beside the AML or MDS for ≥ 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
• All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
• Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days as required by RevAssist) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.
• Between 6 months to 8 months post transplant
• Laboratory tests:
• Neutrophil count of ≥ 1.5 x 109/L
• Platelet count ≥ 50 x 109/L
• Calculated creatinine clearance ≥ 60ml/min by Cockcroft-Gault formula
• Total bilirubin ≤1.5 x upper limit of normal
• AST (SGOT) and ALT (SGPT) ≤ 3 x upper limit of normal

You may not qualify if:

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
• Pregnant or breast feeding females (Lactating females must agree not to breast feed while taking lenalidomide)
• Any level of acute graft versus host disease
• Active, uncontrolled infection are not eligible for this study
• Any condition, including the presence of laboratory abnormalities, which 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
• Use of any other experimental drug or therapy within 28 days of baseline.
• Known hypersensitivity to thalidomide
• Development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drug
• Known sero-positive for active viral infection with HI, hepatitis B virus (HBV) or hepatitis C virus (HCV)
• Mixed chimerism (at 6 months post transplant will not be started on the protocol
• Active AML or MDS at the time of the study are not eligible for this protocol
• Not able to swallow the lenalidomide capsule as a whole are excluded from this study
• Impaired gastrointestinal absorption

Sponsors & Collaborators

• University of California, Davis: lead
• Celgene: collaborator

Study Sites (1)

University of California Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

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

Study Officials

• Mehrdad Abedi, MD

  University of California, Davis

  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: Professor

Study Record Dates

• First Submitted: September 12, 2011
• First Posted: September 14, 2011
• Study Start: August 8, 2012
• Primary Completion: June 12, 2018
• Study Completion: January 12, 2021
• Last Updated: March 10, 2022

Record last verified: 2022-03

Locations

US (1)