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Adult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesPhase 1NCT01246622

Lenalidomide and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

A Phase 1 study testing cytarabine and lenalidomide in people with Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Del(5q), run by Roswell Park Cancer Institute 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

This phase I trial is studying the side effects and best dose of lenalidomide when given together with cytarabine in treating patients with relapsed or refractory acute myeloid leukemia (AML). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
cytarabine and lenalidomide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
7 Feb 2011to 5 Jun 2019
Phase
Phase 1

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

Who may be able to join

  • Patient with relapsed/refractory AML for which no standard effective therapy is anticipated to result in a durable partial or complete remission
  • Eastern Cooperative Oncology Group Performance (ECOG) status 0-2
  • Bilirubin =< 2.5 x upper limit of normal (ULN) unless considered Gilbert's syndrome of leukemia
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN unless considered Gilbert's syndrome of leukemia
  • Partial thromboplastin time (PTT) must be < 1.5 x ULN and international normalized ratio (INR) < 1.5 ULN
  • Phase I subjects must have calculated creatinine clearance >= 50 ml/min by Cockcroft-Gault formula
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  • 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) of lenalidomide 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; all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure
  • Patient is capable of understanding and complying with parameters as outlined in the protocol and able to sign informed consent
  • For patients with thromboembolic risk (history of deep venous thrombosis [DVT]/pulmonary embolism [PE], on medications that increase risk of thrombolic event, etc.) able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin [ASA] may use warfarin or low molecular weight heparin); the risk of blood clots may also be increased when lenalidomide is combined with other drugs known to cause blood clots such as steroids, other forms of cancer drugs, hormone replacement therapy, birth control pills and erythropoietin

Who cannot join

  • Known active central nervous system (CNS) disease
  • The patient has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic or any investigational agents within 14 days or 5 half lives, whichever is greater, prior to drug administration on this study or has not recovered to less than grade 2 clinically significant non-hematological adverse effects/toxicities of the previous therapy except hydroxyurea up to 24 hours prior to cytarabine initiation
  • The patient has a documented left ventricular ejection fraction of < 50 %
  • Active uncontrolled infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris or cardiac arrhythmia
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  • History of adrenal insufficiency
  • Psychiatric illness/social situation that would limit compliance with study requirements
  • 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 virus vaccine are eligible
  • Any medical condition which in the opinion of the study investigator places the patient at an unacceptable high risk of toxicities
  • Lactating or pregnant female (Lactating females must agree not to breast feed while taking lenalidomide)
  • The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
  • Any prior use of lenalidomide
  • Concurrent use of other anti-cancer agents or treatments or any other investigational agent except hydroxyurea up to 24 hours prior to cytarabine initiation

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

Other trials in United States

About this study

Official title: Phase I Trial of Cytarabine and Lenalidomide in Relapsed or Refractory Acute Myeloid Leukemia Patients

This phase I trial is studying the side effects and best dose of lenalidomide when given together with cytarabine in treating patients with relapsed or refractory acute myeloid leukemia (AML). Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with cytarabine may kill more cancer cells

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the maximum tolerated dose (MTD) of lenalidomide following intermediate dose ARA-C (cytarabine) in relapsed/refractory AML.

SECONDARY OBJECTIVES:

  1. Evaluate immune reconstitution in patients in complete remission (CR) treated at the MTD.

II. Evaluate the efficacy of the regimen in the expanded group treated at the MTD.

OUTLINE: This is a dose-escalation study of lenalidomide.

Patients receive lenalidomide orally (PO) on days 6-26 and cytarabine intravenously (IV) over 3 hours on days 1-5. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 2 weeks and then every 3 months thereafter.

Medical subject headings
Congenital Abnormalities, Leukemia, Myeloid, Acute

What participants receive

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

  • cytarabineDrug

    Also called ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-U

    Given IV

  • lenalidomideDrug

    Also called CC-5013, IMiD-1, Revlimid

    Given PO

Study groups in NCT01246622
Study groupRoleWhat they receive
Treatment (biological therapy)ExperimentalPatients receive lenalidomide PO on days 6-26 and cytarabine IV over 3 hours on days 1-5. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: cytarabine; Drug: lenalidomide

What is being measured

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

  1. MTD of lenalidomide following intermediate dose cytarabine

    Assessed by Cancer Therapy Evaluation Program (CTEP) Version 4 of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).

    Measured: Over course 1

  2. Overall response rate

    Measured: Up to 3 years

Timeline

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

  1. First posted23 Nov 2010 (estimated)
  2. Study start7 Feb 2011
  3. Primary completion15 May 2014
  4. Study completion5 Jun 2019

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
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01246622
Sponsor's protocol ID
I 179510
Other IDs
NCI-2010-02080
Status last verified
Sep 2020
First submitted
12 Nov 2010
Last updated
24 Sep 2020
Results posted
No
Data monitoring committee
Yes

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