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Acute Myeloid LeukemiaPhase 1NCT01578954

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

A Phase 1 study testing Lenalidomide in people with Acute Myeloid Leukemia, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
28 Jun 2012to 18 May 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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
  • Patients who have experienced one or more CTCAE v4.0 grade 3-4 treatment-related non-hematologic toxicity within 30 days of beginning the first course of induction therapy.
  • Patients must have recovered from all infectious and non-hematologic toxicities from prior chemotherapy to ≤ CTCAE grade 1 or baseline prior to study enrollment.
  • Adequate renal and hepatic functions as indicated by the following:
  • Renal function assessed by calculated creatinine clearance (CrCl) must be >/= 60ml/min by Cockcroft-Gault formula (
  • Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • AST/ALT ≤ 2.5 x ULN
  • Patients in CRi must have evidence of hematologic recovery after prior therapy to at least:
  • Absolute neutrophils ≥ 0.8 x 109/L
  • Platelets ≥ 75 x 109/L
  • Independent of red blood cell transfusions
  • ECOG performance status 0-2

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: LCCC 1111: An Open-Label Dose-Finding Study of Lenalidomide as Reinduction/ Consolidation Followed by Lenalidomide Maintenance Therapy for Adults ≥ 60 Years of Age With Acute Myeloid Leukemia (AML) in Partial or Complete Response Following Conventional Induction Therapy

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).

Read the detailed description

This study is a single-arm, open-label phase Ib clinical trial testing the hypothesis that the daily use of lenalidomide will be safe and tolerable as evidenced by the rate of dose-limiting toxicity (DLT) seen during one month of reinduction/consolidation in older (≥ 60 years of age) acute myeloid leukemia (AML) patients treated after one cycle of conventional, anthracycline-based induction. (Re-induction is the prescribed lenalidomide therapy given to patients who are in partial remission/response post induction while consolidation is the same prescribed lenalidomide therapy post induction given to patients who are in complete remission).

Dose escalation will take place within cohorts during the 28-day re-induction/ consolidation lenalidomide treatment at the University of North Carolina at Chapel Hill. After re-induction/consolidation, patients who harbor ≥ 5% peripheral blood or bone marrow myeloblasts will be removed from protocol therapy. Patients who have <5% peripheral blood or bone marrow myeloblasts after consolidation therapy will be allowed to continue to maintenance therapy: lenalidomide 10 mg/day continuously for up to 12 months. Up to 26 patients will be enrolled.

This trial includes a Geriatric Assessment (GA) of each enrolled patient at baseline and serially across the trial. The investigators also plan to study natural killer (NK) cell phenotype and cytolytic function in patients at various intervals across the study (baseline, post re-induction/consolidation, and during maintenance.

Being tested
Lenalidomide
Keywords
Leukemia, Acute Myeloid Leukemia
Medical subject headings
Leukemia, Myeloid, Acute, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenalidomideDrug

    Also called Revlimid

    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

Study groups in NCT01578954
Study groupRoleWhat they receive
DrugExperimentalLenalidomide (25, 35, or 50 mg induction/10mg maintenance)
Receives: Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine the rate of dose limiting toxicities.

    Measured: 28 days

Secondary outcomes (4)

  1. Frequency of toxicity

    Number of adverse events that occur during induction/consolidation.

    Measured: 28 days

  2. Duration of toxicity

    Duration is measured by the length of time of a toxicity to resolve or return to baseline that occur during induction.

    Measured: 28 days

  3. Frequency of toxicity

    Frequency will be measured as the number of individual toxicities that occur during maintenance.

    Measured: 12 months

  4. Response rates

    Response is based on the International Working Group to standardize response in AML.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2012 (estimated)
  2. Study start28 Jun 2012
  3. Primary completion18 May 2016
  4. Study completion18 May 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01578954
Sponsor's protocol ID
LCCC 1111
Other IDs
12-0040
Status last verified
Jan 2022
First submitted
13 Apr 2012
Last updated
27 Jan 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 34955443

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lenalidomide in people with Acute Myeloid Leukemia, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the rate of dose limiting toxicities. (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01578954, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.

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