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Liposomal Vincristine Plus Dexamethasone in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00144963
Recruitment Status : Completed
First Posted : September 5, 2005
Results First Posted : January 18, 2012
Last Update Posted : December 12, 2019
Information provided by (Responsible Party):
Acrotech Biopharma LLC

Brief Summary:
The purpose of this study is to find the highest safe dose and to assess the anti-tumor effect of liposomal vincristine with dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia (ALL).

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Drug: Vincristine Sulfate Liposomes Injection Drug: Dexamethasone Phase 1 Phase 2

Detailed Description:


  • Determine the maximum tolerated dose (MTD) of liposomal vincristine given with dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia (ALL).
  • Determine the efficacy of liposomal vincristine given with dexamethasone in these patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I-II Study of Liposomal Vincristine (VSLI) and Dexamethasone in Relapsed or Refractory Acute Lymphoblastic Leukemia
Study Start Date : July 2002
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Arm Intervention/treatment
Experimental: VSLI
Vincristine Sulfate Liposomes Injection (VSLI)
Drug: Vincristine Sulfate Liposomes Injection
Study treatment consists of infusion of VSLI intravenously over 60 minutes on Day 1 and Days 8, 15 and 22 (+/- 2 days).
Other Name: Marqibo

Drug: Dexamethasone
Study treatment consists of 40 mg dexamethasone, daily orally or intravenously, on Days 1-4 (+/- 2 days) and Days 11-14 (+/- 2 days).

Primary Outcome Measures :
  1. MTD of VSLI [ Time Frame: 6 weeks ]
    Subjects had to receive at least 1 course consisting of 4 weekly infusions of VSLI at the assigned drug dose with a minimum 2 weeks of observation after the last VSLI dose to be included in the evaluation of the MTD.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Previously treated, relapsed or refractory ALL (including lymphoblastic lymphoma and Burkitt's subtypes) with measurable disease.
  • Performance status ≤3 (ECOG).
  • All ages are eligible. Those aged 12 years or older may be counted towards the MTD in the Phase I portion of the trial. Pediatric patients are eligible, but must be treated at a dose level previously tested in an adult (one full course).
  • Adequate liver function (bilirubin ≤2 x upper limit normal), and renal function (creatinine ≤2 x upper limit normal).
  • Negative pregnancy test in females of childbearing potential.
  • Patients with prior history of stem cell transplant are eligible if they meet all other eligibility requirements.

Exclusion Criteria:

  • Active serious infection not controlled by oral or intravenous antibiotics.
  • Treatment with any investigational agents or chemotherapy agents in the last 21 days before study entry, unless full recovery from side effects has occurred or the patient has rapidly progressive disease judged to be life threatening by the Investigator.
  • Concurrent treatment with other anti-cancer agents other than dexamethasone.
  • Known CNS leukemia or lymphoma requiring intrathecal or craniospinal radiation therapy or with CNS neuropathy limiting evaluation of study drug. Patients with controlled CNS disease (no progression signs or symptoms at the time of study entry) may be eligible after approval by the Principal Investigator. Lumbar puncture not required in asymptomatic patients.
  • Prior history of Grade 3 or 4 sensory or motor neuropathy related to chemotherapeutic treatment, or persistent Grade 2 or greater active neuropathy.
  • History of active neurologic disorders unrelated to chemotherapy (including familial neurologic diseases and acquired demyelinating disorders).
  • Prior history of hypersensitivity reactions to vincristine or any of the other components of VSLI.
  • Pregnant and/or lactating women; or fertile men or women not willing to use contraception.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00144963

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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Texas
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Acrotech Biopharma LLC
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Principal Investigator: Deborah Thomas, MD MD Anderson Cancer Center, Department of Hematology/Oncology
Principal Investigator: Wendy Stock, MD University of Chicago
Principal Investigator: Leonard Heffner, MD Emory University
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Responsible Party: Acrotech Biopharma LLC Identifier: NCT00144963    
Other Study ID Numbers: VSLI-06-ALL
First Posted: September 5, 2005    Key Record Dates
Results First Posted: January 18, 2012
Last Update Posted: December 12, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action