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

NCT01401322 | Terminated Phase 2 Results DMC

• 4 other identifiers: IRB-19607SU-01142011-7364RV_ALL_PI_0616HEMALL0006
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Time-to-Progression (TTP)

Conditions

Leukemia; Relapsed Adult Acute Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• Time-to-Progression (TTP)

  12 weeks

Study Arms (1)

Lenalidomide 50 mg/day x 28 days

EXPERIMENTAL

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

Interventions

Lenalidomide DRUG

50 mg; po

Also known as: Revlimid

Lenalidomide 50 mg/day x 28 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Celgene Corporation: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Bruno C. Medeiros
• Organization: Stanford University

650-498-6000

Study Officials

• Bruno Carneiro de Medeiros

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine (Hematology)

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: July 25, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: May 1, 2012
• Last Updated: November 28, 2016
• Results First Posted: November 10, 2014

Record last verified: 2016-10

Locations

US (1)