Lenalidomide as Consolidation and Maintenance in Adults >/= 60 Years of Age With AML Following Standard Induction

NCT01578954 | Completed Phase 1 DMC

• 2 other identifiers: LCCC 111112-0040
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to test the safety of the study drug, lenalidomide, at different dose levels in people diagnosed with acute myeloid leukemia (AML) who have finished standard induction therapy and have had a partial or complete response to induction therapy. The investigators want to find out what effects (for example, side effects) the study drug, lenalidomide, has on people and their leukemia. The investigators also want to see if additional treatment (maintenance therapy) with lenalidomide will keep the leukemia from relapsing (coming back).

Conditions

Acute Myeloid Leukemia

Keywords

Leukemia; Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Determine the rate of dose limiting toxicities.

  28 days

Secondary Outcomes (4)

• Frequency of toxicity

  28 days

• Duration of toxicity

  28 days

• Frequency of toxicity

  12 months

• Response rates

  12 months

Study Arms (1)

Drug

EXPERIMENTAL

Lenalidomide (25, 35, or 50 mg induction/10mg maintenance)

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

Reinduction/Consolidation - dose escalation of lenalidomide: Level 1 - 25mg, Level 2 - 35mg, Level 3 - 50mg, PO, QD, 28 days. Maintenance Lenalidomide - 10mg, PO, QD, continuous dosing, 12 months

Also known as: Revlimid

Drug

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥60 years of age with AML
• Patients with therapy-related myeloid neoplasms are allowed
• Patients with AML that has evolved from an antecedent hematologic disorder are allowed
• Patients will be eligible regardless of their ultimate plans or candidacy for allogeneic stem cell transplant
• 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; see definition below) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for re-induction/consolidation (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.
• A FCBP is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
• Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix C: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
• Patients must have been treated with 1-2 courses of intensive therapy as first therapy for AML, commonly described as induction. These therapies should include cytarabine at a dose ≥700 mg/m2 in combination with an anthracycline or anthracenedione (≥ 135 mg/m2 of daunorubicin, 36 mg/m2 of idarubicin or 40 mg/m2 of mitoxantrone)
• Patients must be in morphologic complete response (CR), complete response with incomplete hematologic recovery (CRi) or partial response (PR) by international working group criteria post induction therapy (see Appendix A). Patients in PR who have undergone only one course of intensive induction therapy will be eligible only if one or more of the following criteria are met:
• Patient preference to forgo further intensive induction therapy in favor of low- or intermediate-intensity therapy
• Patients are deemed unlikely to benefit from additional anthracycline-cytarabine induction therapies for any of the following reasons:
• Therapy-related AML
• Prior myelodysplastic syndrome or myeloproliferative neoplasm
• The presence of cytogenetic or molecular genetic features place patient in the Intermediate-I, Intermediate -II or Adverse genetic group as defined by the European LeukemiaNet

You may not qualify if:

• Prior treatment with lenalidomide
• Known hypersensitivity to thalidomide
• Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
• The diagnosis of AML-M3 (acute promyelocytic leukemia) characterized by translocations involving the retinoic acid receptor-alpha (RAR-alpha) gene.
• Use of investigational agents within 2 weeks or any anticancer therapy within 2 weeks before study entry; the patient must have recovered from all acute toxicities from any previous therapy.
• Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); patients who are seropositive because of hepatitis B vaccine are eligible.
• Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment.
• Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
• Have currently active gastrointestinal disease, or prior surgery that may affect the ability of the patient to absorb oral lenalidomide

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Celgene: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill - Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Woods JD, Zeidner JF, Van Deventer HW, Jamieson K, Matson M, Zhang J, Pulley W, Brenizer T, Muss H, Nyrop KA, Vohra SN, Deal AM, Ivanova A, Foster MC. Phase Ib trial of lenalidomide as post-remission therapy for older adults with acute myeloid leukemia: Safety and longitudinal assessment of geriatric functional domains. J Geriatr Oncol. 2022 May;13(4):499-504. doi: 10.1016/j.jgo.2021.11.015. Epub 2021 Dec 23.

  PMID: 34955443 DERIVED

Related Links

• Lineberger Comprehensive Cancer Center Website

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

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

• Matthew C Foster, MD

  UNC Lineberger Comprehensive Cancer Center

  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: SPONSOR

Study Record Dates

• First Submitted: April 13, 2012
• First Posted: April 17, 2012
• Study Start: June 28, 2012
• Primary Completion: May 18, 2016
• Study Completion: May 18, 2016
• Last Updated: January 27, 2022

Record last verified: 2022-01

Locations

US (1)