Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia Who Have Undergone Stem Cell Transplant
This phase I/II trial studies the side effects and best dose of lenalidomide and how well it works in treating older patients with acute myeloid leukemia who have undergone stem cell transplant. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing.
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
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 in Remission
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(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)
Recurrent Adult Acute Myeloid Leukemia
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of Lenalidomide Maintenance After Autologous Stem Cell Transplant for Elderly Patients With Acute Myeloid Leukemia (AML)|
- Relapse free survival rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]The observed relapse free survival rate will be calculated along with its 95% confidence interval. A one sample test on proportion will be used to detect if the relapse free survival rate with lenalidomide is significantly higher than that without the treatment (relapse rate is expected to be > 95%).
- Overall survival [ Time Frame: From transplant until death of any cause, assessed up to 4 years ] [ Designated as safety issue: No ]Kaplan-Meier analysis will be conducted.
|Study Start Date:||December 2013|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (lenalidomide)
Patients receive lenalidomide PO QD on days 1-21. Courses repeat 4 weeks in the absence of disease progression or unacceptable toxicity.
Other Names:Other: laboratory biomarker analysis
I. To determine the safety and efficacy of maintenance lenalidomide post autologous peripheral blood stem cell transplantation (PBSCT) for elderly patients with acute myeloid leukemia (AML).
I. To define maximum tolerated dose (MTD) and establish therapeutic dose level (TDL) of lenalidomide given post autologous transplant for AML.
II. To determine the progression free survival for patients treated with this approach.
III. To determine the overall survival for patients treated with this approach. IV. To determine the role of residual AML stem cells on efficacy of lenalidomide maintenance after autologous PBSCT.
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21. Courses repeat 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 6 months thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02038153
|United States, New York|
|Albert Einstein College of Medicine||Recruiting|
|Bronx, New York, United States, 10461|
|Contact: Ira Braunschweig, MD 718-920-4826 firstname.lastname@example.org|
|Principal Investigator: Ira Braunschweig, MD|
|Sub-Investigator: Volkan Cetin, MD|
|Sub-Investigator: Amit Verma, MD|
|Sub-Investigator: Stefan Barta, MD|
|Sub-Investigator: UIrich Steidl, MD|
|Sub-Investigator: Noah Kornblum, MD|
|Sub-Investigator: Olga Derman, MD|
|Sub-Investigator: Ramakrishna Battini, MD|
|Sub-Investigator: Nan Xue, PhD|
|Montefiore Medical Center||Recruiting|
|Bronx, New York, United States, 10467-2490|
|Contact: Ira Braunschweig 718-920-4826 email@example.com|
|Contact: Jason Carter, PA 718-920-3492 JASOCART@montefiore.org|
|Principal Investigator: Ira Braunschweig|
|Principal Investigator:||Ira Braunschweig||Albert Einstein College of Medicine of Yeshiva University|