VNP40101M in Treating Patients With Richter Syndrome or Refractory or Relapsed Chronic Lymphocytic Leukemia or Other Lymphoproliferative Disorders

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: NCT00304005
Recruitment Status : Completed
First Posted : March 17, 2006
Last Update Posted : July 18, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase I/II trial is studying the side effects and best dose of VNP40101M and to see how well it works in treating patients with Richter syndrome or refractory or relapsed chronic lymphocytic leukemia or other lymphoproliferative disorders.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Drug: laromustine Phase 1 Phase 2

Detailed Description:


  • Determine the maximum tolerated dose (MTD) of VNP40101M in patients with Richter syndrome or refractory or relapsed chronic lymphocytic leukemia or other lymphoproliferative disease. (phase I)
  • Determine the toxic effects of this drug in these patients. (phase I)
  • Determine the efficacy, as determined by overall response rate, of this drug at the MTD determined in phase I in these patients. (phase II)

OUTLINE: This is a phase I dose-escalation study followed by a phase II study.

  • Phase I: Patients receive VNP40101M IV over 30 minutes on day 1. Courses repeat every 3-6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.

  • Phase II: Patients receive VNP40101M at the MTD determined in phase I.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Cloretazine in Patients With Refractory/Relapsed Chronic Lymphocytic Leukemia or Richter's Syndrome
Study Start Date : July 2005
Actual Primary Completion Date : October 2005
Actual Study Completion Date : August 2008

Primary Outcome Measures :
  1. Maximum tolerated dose
  2. Toxicity
  3. Efficacy

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


  • Diagnosis of 1 of the following hematologic malignancies:

    • Fludarabine refractory or relapsed chronic lymphocytic leukemia (CLL)

      • CLL in transformation allowed
    • Richter syndrome
    • Other refractory lymphoproliferative diseases


  • ECOG performance status 0-2
  • Creatinine ≤ 2.0 mg/dL

    • Renal dysfunction due to organ infiltration by disease allowed
  • AST and ALT ≤ 3 times upper limit of normal (ULN) (unless due to organ infiltration by disease)
  • Bilirubin ≤ 1.5 times ULN (unless due to Gilbert's syndrome)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No uncontrolled infection
  • No symptomatic coronary artery disease
  • No arrhythmia not controlled by medication
  • No uncontrolled, symptomatic congestive heart failure
  • No myocardial infarction within the past 3 months
  • No other uncontrolled illness
  • No psychiatric illness or social situation that would preclude study compliance


  • At least 2 weeks since prior cytotoxic therapy except in patients with rapidly progressing disease
  • No other concurrent standard or investigational treatment for this cancer
  • No other concurrent cytotoxic investigational drugs
  • No concurrent disulfiram

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): NCT00304005

United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Vion Pharmaceuticals
Study Chair: Bonny L. Johnson, RN, MSN Vion Pharmaceuticals Identifier: NCT00304005     History of Changes
Other Study ID Numbers: VION-CLI-041
CDR0000465217 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: March 17, 2006    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: August 2008

Keywords provided by National Cancer Institute (NCI):
refractory chronic lymphocytic leukemia
recurrent adult diffuse large cell lymphoma
recurrent adult Hodgkin lymphoma

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell