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A Phase II Study of Lenalidomide (REVLIMID, NSC-703831) for Previously Untreated Non-M3, Deletion 5Q Acute Myeloid Leukemia (AML) in Patients Age 60 or Older Who Decline Remission Induction Chemotherapy


Phase 2
60 Years
N/A
Open (Enrolling)
Both
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

Thank you

Trial Information

A Phase II Study of Lenalidomide (REVLIMID, NSC-703831) for Previously Untreated Non-M3, Deletion 5Q Acute Myeloid Leukemia (AML) in Patients Age 60 or Older Who Decline Remission Induction Chemotherapy


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response rate, defined as the proportion of patients who achieve CR or CRi

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Principal Investigator

Mikkael Sekeres

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group (SWOG) Research Base

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00785

NCT ID:

NCT00352365

Start Date:

June 2006

Completion Date:

Related Keywords:

  • 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
  • Congenital Abnormalities
  • Leukemia
  • Leukemia, Basophilic, Acute
  • Leukemia, Eosinophilic, Acute
  • Leukemia, Erythroblastic, Acute
  • Leukemia, Megakaryoblastic, Acute
  • Leukemia, Monocytic, Acute
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelomonocytic, Acute
  • Leukemia, Myelomonocytic, Chronic
  • Hypereosinophilic Syndrome

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
University of Washington Medical CenterSeattle, Washington  98195-6043
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Group Health CooperativeSeattle, Washington  98112
Great Falls ClinicGreat Falls, Montana  59405
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Bozeman Deaconess HospitalBozeman, Montana  59715
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Harborview Medical CenterSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Welch Cancer CenterSheridan, Wyoming  82801
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Northern Montana HospitalHavre, Montana  59501
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Rocky Mountain OncologyCasper, Wyoming  82609
Shasta Regional Medical CenterRedding, California  96001-0853
Sutter Roseville Medical CenterRoseville, California  95661
Memorial Medical CenterSpringfield, Illinois  62781
Guardian Oncology and Center for WellnessMissoula, Montana  59804
University of RochesterRochester, New York  14642
Montana Cancer Consortium CCOPBillings, Montana  59101
Decatur Memorial HospitalDecatur, Illinois  62526
Montana Cancer SpecialistsMissoula, Montana  59807-7877
University of CincinnatiCincinnati, Ohio  45267-0502
Sutter General HospitalSacramento, California  95816
Hematology-Oncology Centers of the Northern Rockies PCBillings, Montana  59101
Saint Vincent HealthcareBillings, Montana  59101
Deaconess Medical CenterBillings, Montana  59107
Billings ClinicBillings, Montana  59107-7000
Saint James Community Hospital and Cancer Treatment CenterButte, Montana  59701
Berdeaux, Donald MD (UIA Investigator)Great Falls, Montana  59405
Saint Peter's Community HospitalHelena, Montana  59601
Glacier Oncology PLLCKalispell, Montana  59901
Community Medical HospitalMissoula, Montana  59801
Saint Patrick Hospital - Community HospitalMissoula, Montana  59802
Interlakes Foundation Inc-RochesterRochester, New York  14623
Cleveland Clinic Cancer Center IndependenceIndependence, Ohio  44131
Cleveland Clinic Wooster Specialty CenterWooster, Ohio  44691
Saint Joseph HospitalBellingham, Washington  98225
Harrison Bremerton Hematology and OncologyBremerton, Washington  98310
Columbia Basin Hematology and Oncology PLLCKennewick, Washington  99336
Minor and James Medical PLLCSeattle, Washington  98104
The PolyclinicSeattle, Washington  98122
Swedish Medical Center-First HillSeattle, Washington  98122-4307
University of Michigan University HospitalAnn Arbor, Michigan  48109
University of Tennessee - KnoxvilleKnoxville, Tennessee  37920
Skagit Valley HospitalMt. Vernon, Washington  98273
Evergreen Hematology and Oncology PSSpokane, Washington  99218
Salina Regional Health Center.Salina, Kansas  67401
United General HospitalSedro-Woolley, Washington  98284
Cancer Care Center of DecaturDecatur, Illinois  62526
Harrison Poulsbo Hematology and OncologyPoulsbo, Washington  98370