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Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia

Primary Purpose

Adult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia, Adult Acute Megakaryoblastic Leukemia (M7)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
lenalidomide
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Acute Basophilic Leukemia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 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

Sites / Locations

  • University of Arkansas for Medical Sciences
  • Shasta Regional Medical Center
  • Sutter Roseville Medical Center
  • Sutter General Hospital
  • H. Lee Moffitt Cancer Center and Research Institute
  • Cancer Care Center of Decatur
  • Decatur Memorial Hospital
  • Memorial Medical Center
  • Salina Regional Health Center
  • University of Michigan
  • Montana Cancer Consortium CCOP
  • Northern Rockies Radiation Oncology Center
  • Saint Vincent Healthcare
  • Hematology-Oncology Centers of the Northern Rockies PC
  • Billings Clinic
  • Deaconess Medical Center
  • Bozeman Deaconess Cancer Center
  • Bozeman Deaconess Hospital
  • Saint James Community Hospital and Cancer Treatment Center
  • Berdeaux, Donald MD (UIA Investigator)
  • Great Falls Clinic
  • Northern Montana Hospital
  • Saint Peter's Community Hospital
  • Glacier Oncology PLLC
  • Kalispell Medical Oncology
  • Kalispell Regional Medical Center
  • Community Medical Hospital
  • Montana Cancer Specialists
  • Saint Patrick Hospital - Community Hospital
  • Guardian Oncology and Center for Wellness
  • Interlakes Foundation Inc-Rochester
  • University of Rochester
  • University of Cincinnati
  • Cleveland Clinic Cancer Center Independence
  • Cleveland Clinic Wooster Specialty Center
  • University of Tennessee - Knoxville
  • PeaceHealth Saint Joseph Medical Center
  • Harrison Bremerton Hematology and Oncology
  • Columbia Basin Hematology and Oncology PLLC
  • Skagit Valley Hospital
  • Harrison Poulsbo Hematology and Oncology
  • Harborview Medical Center
  • Minor and James Medical PLLC
  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  • Group Health Cooperative
  • Swedish Medical Center-First Hill
  • The Polyclinic
  • University of Washington Medical Center
  • United General Hospital
  • Cancer Care Northwest - Spokane South
  • Evergreen Hematology and Oncology PS
  • Wenatchee Valley Medical Center
  • Rocky Mountain Oncology
  • Welch Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (lenalidomide)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 13, 2006
Last Updated
January 13, 2022
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00352365
Brief Title
Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
July 1, 2011 (Actual)
Study Completion Date
July 1, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
Detailed Description
PRIMARY OBJECTIVES: I. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia, Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (lenalidomide)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
lenalidomide
Other Intervention Name(s)
CC-5013, IMiD-1, Revlimid
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Complete Response
Description
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.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Description
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame
Up to 5 years
Title
Cytogenetic Abnormalities
Description
Number of baseline cytogenetic abnormalities by responders (CR, CRi, and PR) and nonresponders.
Time Frame
Up to 5 years
Title
Total Response
Description
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.
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikkael Sekeres
Organizational Affiliation
SWOG Cancer Research Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Shasta Regional Medical Center
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
Facility Name
Sutter Roseville Medical Center
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Sutter General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Cancer Care Center of Decatur
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781-0001
Country
United States
Facility Name
Salina Regional Health Center
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Montana Cancer Consortium CCOP
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Northern Rockies Radiation Oncology Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Saint Vincent Healthcare
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Hematology-Oncology Centers of the Northern Rockies PC
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59107-7000
Country
United States
Facility Name
Deaconess Medical Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59107
Country
United States
Facility Name
Bozeman Deaconess Cancer Center
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Bozeman Deaconess Hospital
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Saint James Community Hospital and Cancer Treatment Center
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Berdeaux, Donald MD (UIA Investigator)
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Great Falls Clinic
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Northern Montana Hospital
City
Havre
State/Province
Montana
ZIP/Postal Code
59501
Country
United States
Facility Name
Saint Peter's Community Hospital
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Facility Name
Glacier Oncology PLLC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Medical Oncology
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Community Medical Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59801
Country
United States
Facility Name
Montana Cancer Specialists
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Saint Patrick Hospital - Community Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Guardian Oncology and Center for Wellness
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Interlakes Foundation Inc-Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Cleveland Clinic Cancer Center Independence
City
Independence
State/Province
Ohio
ZIP/Postal Code
44131
Country
United States
Facility Name
Cleveland Clinic Wooster Specialty Center
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
University of Tennessee - Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
PeaceHealth Saint Joseph Medical Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Harrison Bremerton Hematology and Oncology
City
Bremerton
State/Province
Washington
ZIP/Postal Code
98310
Country
United States
Facility Name
Columbia Basin Hematology and Oncology PLLC
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Skagit Valley Hospital
City
Mount Vernon
State/Province
Washington
ZIP/Postal Code
98274
Country
United States
Facility Name
Harrison Poulsbo Hematology and Oncology
City
Poulsbo
State/Province
Washington
ZIP/Postal Code
98370
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Minor and James Medical PLLC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Group Health Cooperative
City
Seattle
State/Province
Washington
ZIP/Postal Code
98112
Country
United States
Facility Name
Swedish Medical Center-First Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-4307
Country
United States
Facility Name
The Polyclinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
United General Hospital
City
Sedro-Woolley
State/Province
Washington
ZIP/Postal Code
98284
Country
United States
Facility Name
Cancer Care Northwest - Spokane South
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Evergreen Hematology and Oncology PS
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
Facility Name
Wenatchee Valley Medical Center
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Rocky Mountain Oncology
City
Casper
State/Province
Wyoming
ZIP/Postal Code
82609
Country
United States
Facility Name
Welch Cancer Center
City
Sheridan
State/Province
Wyoming
ZIP/Postal Code
82801
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21551228
Citation
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.
Results Reference
derived

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Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia

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