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A Phase II Study of VNP40101M For Patients With Acute Myelogenous Leukemia Or High-Risk Myelodysplasia

Phase 2
18 Years
Not Enrolling
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

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Trial Information

A Phase II Study of VNP40101M For Patients With Acute Myelogenous Leukemia Or High-Risk Myelodysplasia


- Determine the complete response rate to VNP40101M in patients with acute myelogenous
leukemia or high-risk myelodysplasia .

- Determine the toxic effects of this regimen in these patients.

- Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is an open-label, multicenter study. Patients are stratified to acute
myelogenous leukemia (AML) or high risk myelodysplasia (MDS) patients ≥ 60 years old with no
prior treatment vs AML patients any age in first relapse. (AML patients any age in first
relapse closed to accrual 06/09/05).

Patients receive VNP40101M IV over 30 minutes once on day 1 (course 1).

Four to five weeks after the first course, patients undergo bone marrow aspiration and
biopsy. If the bone marrow is improved but contains residual leukemia, patients receive a
second course of VNP40101M (at the same dose as in course 1). If patients achieve complete
response (CR), or partial CR after the first or second course, a consolidation course may be
given comprising VNP40101M at a reduced dose.

Patients are followed monthly for 6 months, every 2 months for 12 months, and then every 3
months for 18 months .

PROJECTED ACCRUAL: A total of 230 patients (100 with acute myelogenous leukemia (AML) or
high-risk myelodysplasia and 130 with AML in first relapse) will be accrued for this study.

Inclusion Criteria


- Histologically confirmed diagnosis of 1 of the following:

- Acute myelogenous leukemia (AML), meeting the following criteria:

- In first relapse after first treatment-induced complete remission (CR)
(closed to accrual as of 06/09/05)

- Duration of first CR less than 12 months

- No prior treatment for first relapse except hydroxyurea

- FAB type M0, M1, M2, M4-7

- No acute promyelocytic leukemia

- No prior treatment with a standard induction regimen containing cytotoxic
agents* (for patients 60 years of age or older)

- High-risk myelodysplasia, meeting the following criteria:

- 60 years of age and over

- No prior cytotoxic chemotherapy* except hydroxyurea

- Prior gemtuzumab ozogamicin allowed

- High risk defined as International Prognostic Scoring System score ≥ 1.5,
defined by cytogenetics, % marrow blasts, and lineage cytopenias NOTE:
*Prior low-dose, single-agent cytarabine, decitabine, or azacitidine not
considered prior cytotoxic chemotherapy



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified


- Not specified


- Bilirubin ≤ 2.0 mg/dL

- ALT or AST ≤ 5 times upper limit of normal

- Chronic hepatitis allowed


- Creatinine ≤ 2.0 mg/dL


- No myocardial infarction within the past 3 months

- No symptomatic coronary artery disease

- No uncontrolled arrhythmias

- No uncontrolled congestive heart failure

- No other active heart disease


- No uncontrolled active infection

- Not pregnant or nursing

- Fertile patients must use effective contraception


Biologic therapy

- Up to 4 leukapheresis procedures allowed during the first 15 days of study treatment


- See Disease Characteristics

- Concurrent additional hydroxyurea (maximum dose of 5 g daily for up to 4 days)
allowed between days 4 and 15 of each study course to control elevated blast levels

Endocrine therapy

- Not specified


- Not specified


- Not specified


- Recovered from all prior therapy

- At least 72 hours since prior anti-leukemic treatment with a non-cytotoxic agent

- No concurrent disulfiram (Antabuse)

- No other concurrent anticancer drugs except anagrelide within the first 15 days of
study treatment to control elevated platelet counts

- No other concurrent treatment for leukemia, except hydroxyurea used during study

- No other concurrent investigational drugs

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response rate

Safety Issue:


Principal Investigator

Francis J. Giles, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

November 2005

Completion Date:

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • recurrent adult acute myeloid leukemia
  • untreated adult acute myeloid leukemia
  • atypical chronic myeloid leukemia, BCR-ABL1 negative
  • chronic myelomonocytic leukemia
  • myelodysplastic/myeloproliferative neoplasm, unclassifiable
  • secondary myelodysplastic syndromes
  • de novo myelodysplastic syndromes
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • Neoplasms
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Myelodysplastic-Myeloproliferative Diseases



Duke Comprehensive Cancer Center Durham, North Carolina  27710
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
M.D. Anderson Cancer Center at University of Texas Houston, Texas  77030