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A Phase I/II Study of Cloretazine in Patients With Refractory/Relapsed Chronic Lymphocytic Leukemia or Richter's Syndrome

Phase 1/Phase 2
18 Years
Not Enrolling
Leukemia, Lymphoma

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Trial Information

A Phase I/II Study of Cloretazine in Patients With Refractory/Relapsed Chronic Lymphocytic Leukemia or Richter's Syndrome


- 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

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.

Inclusion Criteria


- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Safety Issue:


Principal Investigator

Bonny L. Johnson, RN, MSN

Investigator Role:

Study Chair

Investigator Affiliation:

Vion Pharmaceuticals


United States: Federal Government

Study ID:




Start Date:

July 2005

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • refractory chronic lymphocytic leukemia
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult Hodgkin lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoproliferative Disorders



M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030