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

This study has been terminated.
(low accrual)
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Bruno C. Medeiros, Stanford University
ClinicalTrials.gov Identifier:
NCT01401322
First received: July 20, 2011
Last updated: July 26, 2012
Last verified: July 2012
  Purpose

Primary Objective:

• Determine the complete response (CR) rate, duration of remission of single agent lenalidomide in patients with relapsed/refractory Acute Lymphoblastic Leukemia (ALL), after at least one previous treatment regimen.

Secondary Objective:

• Establish the toxicity profile for lenalidomide in this patient population


Condition Intervention Phase
Leukemia
Adult Acute Lymphocytic Leukemia
Drug: lenalidomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Agent Lenalidomide in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL)

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor Response (TR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: January 2011
Study Completion Date: May 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lenalidomide Drug: lenalidomide
50 mg; po
Other Name: Revlimid

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be eligible to participate in this study, a patient must meet the following criteria:

  • WHO-confirmed Acute lymphoblastic leukemia with > 10% bone marrow or peripheral blood blasts; failed to achieve CR or relapse after prior therapy.
  • Untreated patients > 60, if not candidates for standard induction, will also be eligible to participate.
  • Age >= 18 and not a candidate for alternative, curative treatment regimens
  • Unwilling or unable to receive conventional chemotherapy (any age)
  • ECOG performance status <= 2 (See Appendix B for definitions)
  • Life expectancy > 2 months
  • All study participants must be registered into the mandatory 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 10 - 14 days prior to study enrollment and again within 24 hours prior to prescribing lenalidomide cycle 1 (prescriptions must be filled within 7 days) 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. (See Appendix A: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods).
  • Willing and able to understand and voluntarily sign a written informed consent
  • Able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria:

Patients meeting any of the following criteria will be excluded from this study:

  • Prior therapy with lenalidomide
  • History of intolerance to thalidomide or development of erythema nodosum while taking thalidomide or similar drugs
  • Patients with advanced malignant hepatic tumors.
  • Concomitant treatment with other anti-neoplastic agents, with the exception of hydroxyurea
  • Anti-neoplastic treatment less than four weeks prior to enrollment, with the exception of 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 four weeks of first day of study drug dosing
  • New York Heart Association Class III or IV heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmias with rapid ventricular response (defined as heart rate greater than 100 beats/minute)
  • Uncontrolled psychiatric illness that would limit compliance with requirementsKnown HIV infection, active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients who are seropositive because of hepatitis B virus vaccine are eligible
  • Pregnant or breast feeding females; lactating females must agree not to breast feed 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
  • Laboratory abnormalities:

    • Either creatinine >=1.5 mg/dL or creatinine clearance <=60 mL/min.
    • Total bilirubin > 1.5 x institutional ULN (unless documented Gilbert's syndrome)
    • AST and ALT > 3 x institutional ULN
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401322

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Celgene Corporation
Investigators
Principal Investigator: Bruno Carneiro de Medeiros Stanford University
  More Information

No publications provided

Responsible Party: Bruno C. Medeiros, Assistant Professor of Medicine (Hematology), Stanford University
ClinicalTrials.gov Identifier: NCT01401322     History of Changes
Other Study ID Numbers: HEMALL0006, SU-01142011-7364, RV_ALL_PI_0616
Study First Received: July 20, 2011
Last Updated: July 26, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Lenalidomide
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014