Arsenic Trioxide in Treating 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: NCT00006008
Recruitment Status : Completed
First Posted : November 5, 2003
Last Update Posted : June 21, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have relapsed or refractory acute lymphoblastic leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Drug: arsenic trioxide Phase 2

Detailed Description:


  • Determine the complete remission rate of patients with relapsed or refractory acute lymphoblastic leukemia treated with arsenic trioxide.
  • Determine the toxic effects of induction arsenic trioxide in this patient population.

OUTLINE: Patients are stratified according to administration schedule of arsenic trioxide (5 days a week vs 7 days a week).

Patients receive arsenic trioxide IV over 1 hour daily until bone marrow blasts are less than 5% or for a maximum of 60 days. Beginning 3-6 weeks after induction, patients achieving a complete remission receive arsenic trioxide IV over 1 hour daily either 5 days or 7 days a week for 25 days. Subsequent consolidation courses are given with 4 week treatment-free intervals between courses. Treatment continues for a maximum of 5 consolidation courses in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 13-40 patients will be accrued for this study within 3 years.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Arsenic Trioxide (NSC #706363) for Relapsed or Refractory Acute Lymphoblastic Leukemia
Study Start Date : June 2000
Actual Study Completion Date : September 2006

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Morphologically proven acute lymphoblastic leukemia (ALL)

    • Subtypes L1, L2, or L3
    • Bone marrow morphology with greater than 25% lymphoblasts
    • ALL morphology and cytochemistry with myeloid markers eligible
  • Refractory to induction therapy or relapsed following chemotherapy or autologous blood or bone marrow transplantation

    • Any number of prior relapses allowed
    • No relapse following allogeneic transplantation
  • Prior CNS leukemia allowed if treated and currently disease-free



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 6 months


  • Not specified


  • Bilirubin no greater than 2.0 mg/dL
  • SGOT/SGPT no greater than 2 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2 times ULN


  • Creatinine no greater than 2 mg/dL


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No significant active infection
  • No other medical conditions that would likely decrease life expectancy
  • No other prior malignancy within the past 5 years except cured basal or squamous cell skin cancer or carcinoma in situ of the cervix


Biologic therapy:

  • See Disease Characteristics


  • See Disease Characteristics

Endocrine therapy:

  • At least 2 weeks since prior systemic corticosteroids


  • Not specified


  • Not specified


  • No concurrent antibiotics for active or resolving infection

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): NCT00006008

  Show 71 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Mark R. Litzow, MD Mayo Clinic

Publications of Results: Identifier: NCT00006008     History of Changes
Other Study ID Numbers: CDR0000068016
First Posted: November 5, 2003    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: August 2002

Keywords provided by National Cancer Institute (NCI):
recurrent adult acute lymphoblastic leukemia
L1 adult acute lymphoblastic leukemia
L2 adult acute lymphoblastic leukemia
L3 adult acute lymphoblastic leukemia

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Arsenic trioxide
Antineoplastic Agents