Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00352365
• Other study ID #: NCI-2009-00785
• Secondary ID: NCI-2009-00785SW
• Status: Completed
• Phase: Phase 2
• Start date: June 2006
• Est. completion date: July 1, 2011

Study information

• Verified date: January 2022
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 1, 2011
• Est. primary completion date: July 1, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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)
• Hypereosinophilic Syndrome
• Leukemia
• Leukemia, Erythroblastic, Acute
• Leukemia, Megakaryoblastic, Acute
• Leukemia, Monocytic, Acute
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Leukemia, Myelomonocytic, Acute
• Secondary Acute Myeloid Leukemia
• Untreated Adult Acute Myeloid Leukemia

Intervention

Drug:
• lenalidomide
Given orally

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	PeaceHealth Saint Joseph Medical Center	Bellingham	Washington
United States	Billings Clinic	Billings	Montana
United States	Deaconess Medical Center	Billings	Montana
United States	Hematology-Oncology Centers of the Northern Rockies PC	Billings	Montana
United States	Montana Cancer Consortium CCOP	Billings	Montana
United States	Northern Rockies Radiation Oncology Center	Billings	Montana
United States	Saint Vincent Healthcare	Billings	Montana
United States	Bozeman Deaconess Cancer Center	Bozeman	Montana
United States	Bozeman Deaconess Hospital	Bozeman	Montana
United States	Harrison Bremerton Hematology and Oncology	Bremerton	Washington
United States	Saint James Community Hospital and Cancer Treatment Center	Butte	Montana
United States	Rocky Mountain Oncology	Casper	Wyoming
United States	University of Cincinnati	Cincinnati	Ohio
United States	Cancer Care Center of Decatur	Decatur	Illinois
United States	Decatur Memorial Hospital	Decatur	Illinois
United States	Berdeaux, Donald MD (UIA Investigator)	Great Falls	Montana
United States	Great Falls Clinic	Great Falls	Montana
United States	Northern Montana Hospital	Havre	Montana
United States	Saint Peter's Community Hospital	Helena	Montana
United States	Cleveland Clinic Cancer Center Independence	Independence	Ohio
United States	Glacier Oncology PLLC	Kalispell	Montana
United States	Kalispell Medical Oncology	Kalispell	Montana
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	Columbia Basin Hematology and Oncology PLLC	Kennewick	Washington
United States	University of Tennessee - Knoxville	Knoxville	Tennessee
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Community Medical Hospital	Missoula	Montana
United States	Guardian Oncology and Center for Wellness	Missoula	Montana
United States	Montana Cancer Specialists	Missoula	Montana
United States	Saint Patrick Hospital - Community Hospital	Missoula	Montana
United States	Skagit Valley Hospital	Mount Vernon	Washington
United States	Harrison Poulsbo Hematology and Oncology	Poulsbo	Washington
United States	Shasta Regional Medical Center	Redding	California
United States	Interlakes Foundation Inc-Rochester	Rochester	New York
United States	University of Rochester	Rochester	New York
United States	Sutter Roseville Medical Center	Roseville	California
United States	Sutter General Hospital	Sacramento	California
United States	Salina Regional Health Center	Salina	Kansas
United States	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Seattle	Washington
United States	Group Health Cooperative	Seattle	Washington
United States	Harborview Medical Center	Seattle	Washington
United States	Minor and James Medical PLLC	Seattle	Washington
United States	Swedish Medical Center-First Hill	Seattle	Washington
United States	The Polyclinic	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington
United States	United General Hospital	Sedro-Woolley	Washington
United States	Welch Cancer Center	Sheridan	Wyoming
United States	Cancer Care Northwest - Spokane South	Spokane	Washington
United States	Evergreen Hematology and Oncology PS	Spokane	Washington
United States	Memorial Medical Center	Springfield	Illinois
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Wenatchee Valley Medical Center	Wenatchee	Washington
United States	Cleveland Clinic Wooster Specialty Center	Wooster	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 5 years
Secondary	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.	Up to 5 years
Secondary	Cytogenetic Abnormalities	Number of baseline cytogenetic abnormalities by responders (CR, CRi, and PR) and nonresponders.	Up to 5 years
Secondary	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.	Up to 5 years