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

NCT ID: NCT01401322

Last Updated: 2016-11-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-05-31

Brief Summary

Time-to-Progression (TTP)

Detailed 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.

Conditions

Leukemia; Relapsed Adult Acute Lymphocytic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lenalidomide 50 mg/day x 28 days

Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.

Group Type: EXPERIMENTAL

Lenalidomide

Intervention Type: DRUG

50 mg; po

Interventions

Lenalidomide

50 mg; po

Intervention Type: DRUG

Other Intervention Names

Revlimid

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Bruno C. Medeiros

Assistant Professor of Medicine (Hematology)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruno Carneiro de Medeiros

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

SU-01142011-7364

Identifier Type: OTHER

Identifier Source: secondary_id

RV_ALL_PI_0616

Identifier Type: OTHER

Identifier Source: secondary_id

HEMALL0006

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-19607

Identifier Type: -

Identifier Source: org_study_id