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
60 Years
N/A
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
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 Institute | Tampa, Florida 33612 |
| University of Washington Medical Center | Seattle, Washington 98195-6043 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Group Health Cooperative | Seattle, Washington 98112 |
| Great Falls Clinic | Great Falls, Montana 59405 |
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
| Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
| Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
| Kalispell Medical Oncology | Kalispell, Montana 59901 |
| Kalispell Regional Medical Center | Kalispell, Montana 59901 |
| Harborview Medical Center | Seattle, Washington 98104 |
| Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
| Welch Cancer Center | Sheridan, Wyoming 82801 |
| Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
| Northern Montana Hospital | Havre, Montana 59501 |
| Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
| Rocky Mountain Oncology | Casper, Wyoming 82609 |
| Shasta Regional Medical Center | Redding, California 96001-0853 |
| Sutter Roseville Medical Center | Roseville, California 95661 |
| Memorial Medical Center | Springfield, Illinois 62781 |
| Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
| University of Rochester | Rochester, New York 14642 |
| Montana Cancer Consortium CCOP | Billings, Montana 59101 |
| Decatur Memorial Hospital | Decatur, Illinois 62526 |
| Montana Cancer Specialists | Missoula, Montana 59807-7877 |
| University of Cincinnati | Cincinnati, Ohio 45267-0502 |
| Sutter General Hospital | Sacramento, California 95816 |
| Hematology-Oncology Centers of the Northern Rockies PC | Billings, Montana 59101 |
| Saint Vincent Healthcare | Billings, Montana 59101 |
| Deaconess Medical Center | Billings, Montana 59107 |
| Billings Clinic | Billings, Montana 59107-7000 |
| Saint James Community Hospital and Cancer Treatment Center | Butte, Montana 59701 |
| Berdeaux, Donald MD (UIA Investigator) | Great Falls, Montana 59405 |
| Saint Peter's Community Hospital | Helena, Montana 59601 |
| Glacier Oncology PLLC | Kalispell, Montana 59901 |
| Community Medical Hospital | Missoula, Montana 59801 |
| Saint Patrick Hospital - Community Hospital | Missoula, Montana 59802 |
| Interlakes Foundation Inc-Rochester | Rochester, New York 14623 |
| Cleveland Clinic Cancer Center Independence | Independence, Ohio 44131 |
| Cleveland Clinic Wooster Specialty Center | Wooster, Ohio 44691 |
| Saint Joseph Hospital | Bellingham, Washington 98225 |
| Harrison Bremerton Hematology and Oncology | Bremerton, Washington 98310 |
| Columbia Basin Hematology and Oncology PLLC | Kennewick, Washington 99336 |
| Minor and James Medical PLLC | Seattle, Washington 98104 |
| The Polyclinic | Seattle, Washington 98122 |
| Swedish Medical Center-First Hill | Seattle, Washington 98122-4307 |
| University of Michigan University Hospital | Ann Arbor, Michigan 48109 |
| University of Tennessee - Knoxville | Knoxville, Tennessee 37920 |
| Skagit Valley Hospital | Mt. Vernon, Washington 98273 |
| Evergreen Hematology and Oncology PS | Spokane, Washington 99218 |
| Salina Regional Health Center. | Salina, Kansas 67401 |
| United General Hospital | Sedro-Woolley, Washington 98284 |
| Cancer Care Center of Decatur | Decatur, Illinois 62526 |
| Harrison Poulsbo Hematology and Oncology | Poulsbo, Washington 98370 |
