Lenalidomide and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT01246622|
Recruitment Status : Active, not recruiting
First Posted : November 23, 2010
Last Update Posted : March 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Recurrent Adult Acute Myeloid Leukemia||Drug: cytarabine Drug: lenalidomide||Phase 1|
I. Determine the maximum tolerated dose (MTD) of lenalidomide following intermediate dose ARA-C (cytarabine) in relapsed/refractory AML.
I. Evaluate immune reconstitution in patients in complete remission (CR) treated at the MTD.
II. Evaluate the efficacy of the regimen in the expanded group treated at the MTD.
OUTLINE: This is a dose-escalation study of lenalidomide.
Patients receive lenalidomide orally (PO) on days 6-26 and cytarabine intravenously (IV) over 3 hours on days 1-5. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 2 weeks and then every 3 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Cytarabine and Lenalidomide in Relapsed or Refractory Acute Myeloid Leukemia Patients|
|Actual Study Start Date :||February 7, 2011|
|Actual Primary Completion Date :||May 1, 2014|
|Estimated Study Completion Date :||June 1, 2018|
Experimental: Treatment (biological therapy)
Patients receive lenalidomide PO on days 6-26 and cytarabine IV over 3 hours on days 1-5. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
- MTD of lenalidomide following intermediate dose cytarabine [ Time Frame: Over course 1 ]Assessed by Cancer Therapy Evaluation Program (CTEP) Version 4 of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
- Overall response rate [ Time Frame: Up to 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01246622
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Elizabeth Griffiths, MD||Roswell Park Cancer Institute|