Single Agent Lenalidomide in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia

Leukemia Clinical Trial

Official title:

Single Agent Lenalidomide in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01401322
• Other study ID #: IRB-19607
• Secondary ID: SU-01142011-7364
• Status: Terminated
• Phase: Phase 2
• First received: July 20, 2011
• Last updated: November 3, 2014
• Start date: January 2011
• Est. completion date: May 2012

Study information

• Verified date: November 2014
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Time-to-Progression (TTP)

Description:

Determine the time-to-progression (TTP) for subjects with relapsed/refractory acute lymphoblastic leukemia (ALL) receiving single agent lenalidomide 50 mg/day for 28 days/cycle.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: May 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Relapsed or refractory acute lymphoblastic leukemia (ALL) with > 10% bone marrow or peripheral blood blasts per WHO-criteria. Refractory define as failure to achieve CR after prior therapy.

• Previously untreated patients > 60, if not candidates for standard induction

• Age = 18

• Not a candidate for curative treatment regimens

• Unwilling or unable to receive conventional chemotherapy

• ECOG performance status = 2

• Life expectancy > 2 months

• Registered to in RevAssist restricted distribution program, and willing and able to comply with the program requirement

• Females of childbearing potential (FCBP):

• Must have a negative serum or urine pregnancy test (sensitivity of at least 50 mIU/mL) 10 to 14 days prior to study enrollment and within 24 hours prior to prescribing lenalidomide

• Must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control

• Agree to ongoing pregnancy testing

• Men must agree to use a latex condom during sexual contact with a FCBP

• Able to adhere to the study visit schedule and other protocol requirements

• Willing and able to understand and voluntarily sign a written informed consent

Exclusion Criteria:

• Prior therapy with lenalidomide

• History of intolerance to thalidomide including development of erythema nodosum while taking thalidomide or similar drugs

• Advanced malignant hepatic tumors.

• Concomitant treatment with other anti-neoplastic agents (exception hydroxyurea)

• Anti-neoplastic treatment less than 4 weeks prior to enrollment (exception hydroxyurea)

• Use of any other experimental drug or therapy within 14 days of baseline

• Inability to swallow or absorb drug

• Active opportunistic infection or treatment for opportunistic infection within 4 weeks of first dose of study drug

• New York Heart Association Class III or IV heart failure

• Unstable angina pectoris

• Cardiac arrhythmias with rapid ventricular response (heart rate > 100 beats/minute)

• Uncontrolled psychiatric illness that would limit compliance with requirements

• Known HIV infection

• Known active hepatitis B virus (HBV) (exception seropositivity due to HBV vaccine not considered active HBV)

• Known hepatitis C virus (HCV) infection

• Pregnant

• Lactating females must agree not to breastfeed while taking lenalidomide

• Other medical or psychiatric illness or organ dysfunction or laboratory abnormality which in the opinion of the investigator would compromise the patient's safety or interfere with data interpretation

• Creatinine = 1.5 mg/dL

• Creatinine clearance = 60 mL/min.

• Total bilirubin > 1.5 x institutional upper limit of normal (ULN) (exception documented Gilbert's syndrome)

• AST and ALT > 3 x institutional ULN

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Relapsed Adult Acute Lymphocytic Leukemia

Intervention

Drug:
• Lenalidomide
50 mg; po

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-to-Progression (TTP)		12 weeks	No