Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia - Full Text View

Sponsors and Collaborators:	Southwest Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00352365

Purpose

RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing.

PURPOSE: This phase II trial is studying how well lenalidomide works in treating older patients with acute myeloid leukemia with abnormal chromosome 5q.

Condition	Intervention	Phase
Leukemia	Drug: lenalidomide	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Lenalidomide CC 5013

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Complete response rate [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Relationship of additional cytogenetic abnormalities and response to lenalidomide [ Designated as safety issue: No ]
Total response rate [ Designated as safety issue: No ]
Cytogenetic response rate [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	June 2006
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

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.
Estimate the frequency and severity of toxicities of this drug in these patients.
Correlate, in a preliminary manner, additional cytogenetic abnormalities with response to lenalidomide.
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.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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
Southwest Oncology Group (SWOG) patients must be registered on SWOG-9007
No acute promyelocytic leukemia (FAB M3)
No blastic transformation of chronic myelogenous leukemia

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
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
Concurrent enrollment on SWOG-S9910 allowed (for SWOG patients)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352365

Show 46 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Mikkael A. Sekeres, MD, MS

The Cleveland Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Southwest Oncology Group - Group Chair's Office ( Laurence H. Baker )
Study ID Numbers:	CDR0000484449, SWOG-S0605
Study First Received:	July 13, 2006
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00352365 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

untreated adult acute myeloid leukemia
adult erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)
adult acute megakaryoblastic leukemia (M7)
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 myelomonocytic leukemia (M4)

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)
secondary acute myeloid leukemia
adult acute minimally differentiated myeloid leukemia (M0)
adult acute basophilic leukemia
adult acute eosinophilic leukemia

Study placed in the following topic categories:

Leukemia, Monocytic, Acute
Lenalidomide
Acute Myelomonocytic Leukemia
Leukemia, Myeloid
Acute Monoblastic Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myelomonocytic, Acute
Leukemia

Acute Myelocytic Leukemia
Acute Erythroblastic Leukemia
Leukemia, Erythroblastic, Acute
Acute Myeloid Leukemia, Adult
Neoplasm Metastasis
Congenital Abnormalities
Di Guglielmo's Syndrome

Additional relevant MeSH terms:

Leukemia
Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses

Lenalidomide
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009