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Adult Acute Basophilic LeukemiaPhase 2NCT00352365

Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia

A Phase 2 study testing lenalidomide in people with Adult Acute Basophilic Leukemia and Adult Acute Eosinophilic Leukemia, run by National Cancer Institute (NCI) at 54 sites 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 II trial is studying how well lenalidomide works in treating older patients with acute myeloid leukemia with abnormal chromosome 5q. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
lenalidomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
54 sitesUnited States
Study dates
Jun 2006to 1 Jul 2011
Phase
Phase 2

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

  • Morphologically confirmed diagnosis of acute myeloid leukemia (AML) by bone marrow aspiration and biopsy within the past 14 days
  • Diagnostic biopsy within the past 28 days with marrow blast percentage ≥ 70% allowed provided no potentially antileukemic therapy was received after biopsy
  • Cytogenetic evidence of del (5q) abnormality by conventional karyotyping or fluorescence in situ hybridization (FISH)
  • Previously untreated disease
  • Must have declined standard AML cytotoxic chemotherapy regimens
  • WBC ≤ 30,000/mm³
Show all 28Show fewer
  • History of prior myelodysplastic syndromes (MDS) allowed
  • No acute promyelocytic leukemia (FAB M3)
  • No blastic transformation of chronic myelogenous leukemia
  • Zubrod performance status 0-2
  • Bilirubin ≤ 2.5 times upper limit of normal (ULN) (unless elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis, but not to liver dysfunction)
  • AST and ALT ≤ 3.5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 forms of effective contraception at least 4 weeks prior to, during, and for 4 weeks after completion of study treatment
  • No known allergy to thalidomide
  • Concurrent enrollment on SWOG-S9910 allowed (for SWOG patients)
  • No prior systemic chemotherapy for acute leukemia except hydroxyurea
  • Single-dose intrathecal chemotherapy allowed before or concurrently with induction chemotherapy
  • No prior AML induction-type chemotherapy or high-dose chemotherapy with hematopoietic stem cell support
  • Prior hematopoietic growth factors, thalidomide, arsenic trioxide, signal-transduction inhibitors, azacitidine, and low-dose cytarabine (i.e., < 100 mg/m²/day) for treatment of MDS allowed
  • At least 30 days since prior therapy for MDS (excluding growth factors)
  • No prior lenalidomide for MDS
  • At least 6 months since prior chemotherapy or radiotherapy for another malignancy
  • No concurrent therapy for another malignancy
  • Concurrent hormonal therapy allowed

Who cannot join

None listed.

Trial locations and contacts

54 sites in 1 country.

54 sites in 1 country

United States54 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Montana Cancer Consortium CCOP

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies PC

    Billings, Montana, 59102

  • Billings Clinic

    Billings, Montana, 59107-7000

  • Deaconess Medical Center

    Billings, Montana, 59107

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Harrison Bremerton Hematology and Oncology

    Bremerton, Washington, 98310

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Cancer Care Center of Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Berdeaux, Donald MD (UIA Investigator)

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Northern Montana Hospital

    Havre, Montana, 59501

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Cleveland Clinic Cancer Center Independence

    Independence, Ohio, 44131

  • Glacier Oncology PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Columbia Basin Hematology and Oncology PLLC

    Kennewick, Washington, 99336

  • University of Tennessee - Knoxville

    Knoxville, Tennessee, 37920

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Community Medical Hospital

    Missoula, Montana, 59801

  • Montana Cancer Specialists

    Missoula, Montana, 59802

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Skagit Valley Hospital

    Mount Vernon, Washington, 98274

  • Harrison Poulsbo Hematology and Oncology

    Poulsbo, Washington, 98370

  • Shasta Regional Medical Center

    Redding, California, 96001

  • Interlakes Foundation Inc-Rochester

    Rochester, New York, 14623

  • University of Rochester

    Rochester, New York, 14642

  • Sutter Roseville Medical Center

    Roseville, California, 95661

  • Sutter General Hospital

    Sacramento, California, 95816

  • Salina Regional Health Center

    Salina, Kansas, 67401

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Minor and James Medical PLLC

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Seattle, Washington, 98109

  • Group Health Cooperative

    Seattle, Washington, 98112

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122-4307

  • The Polyclinic

    Seattle, Washington, 98122

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • United General Hospital

    Sedro-Woolley, Washington, 98284

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Evergreen Hematology and Oncology PS

    Spokane, Washington, 99218

  • Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801

  • Cleveland Clinic Wooster Specialty Center

    Wooster, Ohio, 44691

Other trials in United States

About this study

Official title: A Phase II Study of Lenalidomide (REVLIMID, NSC-703813) for Previously Untreated Non-M3, Deletion 5q Acute Myeloid Leukemia (AML) in Patients Age 60 or Older Who Decline Remission Induction Chemotherapy

This phase II trial is studying how well lenalidomide works in treating older patients with acute myeloid leukemia with abnormal chromosome 5q. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Test whether the complete response rate among older patients with previously untreated acute myeloid leukemia (AML) with the del (5q) cytogenetic abnormality treated with lenalidomide is sufficiently high to warrant a phase III investigation.

II. Estimate the frequency and severity of toxicities of this drug in these patients.

III. Correlate, in a preliminary manner, additional cytogenetic abnormalities with response to lenalidomide.

IV. Estimate the total (complete and partial) response rate and the cytogenetic response rate in these patients.

OUTLINE:

INDUCTION THERAPY: Patients receive oral lenalidomide once daily on days 1-14, 1-21, or 1-28 (course 1). Patients undergo bone marrow biopsy on day 28 or 35 to assess treatment efficacy. Patients with stable or improving disease (i.e., a decrease in blast percentage) without progressive disease proceed to maintenance therapy.

MAINTENANCE THERAPY: Beginning within 42 days after completion of induction therapy, patients receive oral lenalidomide once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 5 years.

Being tested
lenalidomide
Medical subject headings
Leukemia, Basophilic, Acute, Leukemia, Eosinophilic, Acute, Leukemia, Megakaryoblastic, Acute, Leukemia, Monocytic, Acute, Leukemia, Myeloid, Acute, Congenital Abnormalities, Leukemia, Myelomonocytic, Acute, Leukemia, Erythroblastic, Acute

What participants receive

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

  • lenalidomideDrug

    Also called CC-5013, IMiD-1, Revlimid

    Given orally

Study groups in NCT00352365
Study groupRoleWhat they receive
Treatment (lenalidomide)ExperimentalINDUCTION THERAPY: Patients receive oral lenalidomide once daily on days 1-14, 1-21, or 1-28 (course 1). Patients undergo bone marrow biopsy on day 28 or 35 to assess treatment efficacy. Patients with stable or improving disease (i.e., a decrease in blast percentage) without progressive disease proceed to maintenance therapy. MAINTENANCE THERAPY: Beginning within 42 days after completion of induction therapy, patients receive oral lenalidomide once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: lenalidomide

What is being measured

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

  1. Complete Response

    Morphologic complete remission (CR): ANC >=1,000/mcl, platelet count >=100,000/mcl, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcl and/or platelet count <100,000/mcl.

    Measured: Up to 5 years

Secondary outcomes (3)

  1. Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug

    Only adverse events that are possibly, probably or definitely related to study drug are reported.

    Measured: Up to 5 years

  2. Cytogenetic Abnormalities

    Number of baseline cytogenetic abnormalities by responders (CR, CRi, and PR) and nonresponders.

    Measured: Up to 5 years

  3. Total Response

    Morphologic complete remission (CR): ANC >=1,000/mcl, platelet count >=100,000/mcl, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcl and/or platelet count <100,000/mcl. Partial remission (PR): ANC >1,000/mcl, platelet count >100,000/mcl, and at least 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts <5% with persistent Auer rods.

    Measured: Up to 5 years

Timeline

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

  1. First posted14 Jul 2006 (estimated)
  2. Study startJun 2006
  3. Primary completion1 Jul 2011
  4. Study completion1 Jul 2011

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00352365
Sponsor's protocol ID
NCI-2009-00785
Other IDs
NCI-2009-00785, SWOG-S0605, CDR0000484449, S0605, S0605, U10CA032102
Status last verified
Jan 2022
First submitted
13 Jul 2006
Last updated
11 Feb 2022

Publications

  • Sekeres MA, Gundacker H, Lancet J, Advani A, Petersdorf S, Liesveld J, Mulford D, Norwood T, Willman CL, Appelbaum FR, List AF. A phase 2 study of lenalidomide monotherapy in patients with deletion 5q acute myeloid leukemia: Southwest Oncology Group Study S0605. Blood. 2011 Jul 21;118(3):523-8. doi: 10.1182/blood-2011-02-337303. Epub 2011 May 6.

    PubMed 21551228

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