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Lenalidomide and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Not Recruiting
Trial ID: NCT01904643
Purpose
This phase I trial studies the side effects and the best dose of lenalidomide when given
together with combination chemotherapy in treating patients with relapsed or refractory acute
myeloid leukemia. Lenalidomide may stop the growth of acute myeloid leukemia by blocking
blood flow to the cancer. Drugs used in chemotherapy, such as mitoxantrone hydrochloride,
etoposide, and cytarabine, work in different ways to stop the growth of cancer cells, either
by killing the cells or by stopping them from dividing. Giving lenalidomide and combination
chemotherapy may be an effective treatment for acute myeloid leukemia.
Official Title
A Phase I Study of Lenalidomide Therapy Prior to Re-induction Chemotherapy With Mitoxantrone, Etoposide, and Cytarabine (MEC) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (AML)
Stanford Investigator(s)
David Iberri
Clinical Assistant Professor, Medicine - Hematology
Eligibility
Inclusion Criteria:
- Patients eligible include those with diagnosis of AML other than acute promyelocytic
leukemia by World Health Organization (WHO) criteria with relapsed disease after
induction therapy or refractory to induction chemotherapy, as determined by morphology
on bone marrow biopsy; also eligible are patients unwilling to receive standard
induction chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Serum creatinine =< 1.5 mg/dL; if serum creatinine > 1.5 mg/dL, then the estimated
glomerular filtrate rate (GFR) must be > 60ml/min/1.73m^2 as calculated by the
Modification of Diet in Renal Disease equation
- Serum bilirubin =< 1.5 x upper limit of normal (ULN) unless elevation is considered to
be secondary to Gilbert's syndrome, hemolysis, or hepatic infiltration by AML
- Aspartate transaminase (AST)/alanine transaminase (ALT) =< 2.5 x ULN
- Alkaline phosphatase =< 2.5 x ULN
- All study participants must be registered into the mandatory Revlimid assistance
(RevAssist) program, and be willing and able to comply with the requirements of
RevAssist
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy
test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24
hours prior to prescribing lenalidomide for cycle 1 (prescriptions must be filled
within 7 days as required by RevAssist) and must either commit to continued abstinence
from heterosexual intercourse or begin TWO acceptable methods of birth control, one
highly effective method and one additional effective method AT THE SAME TIME, at least
28 days before she starts taking lenalidomide; FCBP must also agree to ongoing
pregnancy testing; men must agree to use a latex condom during sexual contact with a
FCBP even if they have had a successful vasectomy
Exclusion Criteria:
- Patient must not undergo concomitant radiotherapy, chemotherapy or immunotherapy;
patient must not be in concurrent study with other investigational agents
- Patients who have received prior lenalidomide therapy are not eligible for this study;
further there should be at least a 14-day window from the patient's last prior therapy
before initiation of treatment on clinical trial
- Have other severe concurrent disease or serious organ dysfunction involving the heart,
kidney, liver or other organ system that may place the patient at undue risk to
undergo treatment
- Have significant, uncontrolled active infection
- Pregnant or nursing patients will be excluded from the study
- Known human immunodeficiency virus (HIV) infection
Intervention(s):
drug: lenalidomide
drug: mitoxantrone hydrochloride
drug: etoposide
drug: cytarabine
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061