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

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

Time-to-Progression (TTP)

Study Overview

• Status: Terminated
• Conditions: Leukemia; Relapsed Adult Acute Lymphocytic Leukemia
• Intervention / Treatment: Drug: Lenalidomide

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Lenalidomide; 50 mg; po; Other Names: Revlimid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time-to-Progression (TTP)	12 weeks

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Celgene Corporation

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: July 20, 2011
• First Submitted That Met QC Criteria: July 22, 2011
• First Posted (Estimate): July 25, 2011

Study Record Updates

• Last Update Posted (Estimate): November 28, 2016
• Last Update Submitted That Met QC Criteria: October 17, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Lenalidomide
• Other Study ID Numbers: IRB-19607; SU-01142011-7364 (Other Identifier: Stanford University); RV_ALL_PI_0616 (Other Identifier: Celgene Corporation); HEMALL0006 (Other Identifier: OnCore)