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Cytarabine With or Without VNP40101M in Treating Patients With Relapsed Acute Myeloid Leukemia

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
cytarabine
laromustine
placebo
Sponsored by
Vion Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), recurrent adult acute myeloid leukemia, adult acute basophilic leukemia, adult acute eosinophilic leukemia, adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed acute myeloid leukemia (AML) Any WHO classification, excluding acute promyelocytic leukemia At least 10% blasts by bone marrow aspirate and/or biopsy In first relapse after achieving a first complete response (CR) OR CR (with platelet count < 100,000/mm³ but ≥ 20,000/mm³ [transfusion independent for ≥ 7 consecutive days]) (CRp) that lasted ≥ 3 months but ≤ 24 months after completion of the initial induction regimen Relapse confirmed by recurrence of blasts in peripheral blood, bone marrow histopathology, and/or histologically confirmed CNS or extramedullary disease PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic See Disease Characteristics Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST ≤ 3 times ULN Chronic hepatitis allowed Renal Creatinine ≤ 2.0 mg/dL Cardiovascular No myocardial infarction within the past 3 months No uncontrolled arrhythmias No uncontrolled congestive heart failure Pulmonary No severe chronic obstructive pulmonary disease No requirement for supplemental oxygen at rest Immunologic No uncontrolled active infection Infections that are controlled and under active treatment with antibiotics allowed No evidence of invasive fungal infection by blood or tissue cultures Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study treatment No clinical evidence of another active malignancy by tumor marker, pathology, or radiologic studies No other severe medical condition that would preclude study treatment PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy At least 12 hours since prior hydroxyurea Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other No prior treatment while in first relapse except hydroxyurea No other concurrent standard or investigational treatment for AML No concurrent disulfiram (Antabuse®)

Sites / Locations

  • USC/Norris Comprehensive Cancer Center and Hospital
  • Jonsson Comprehensive Cancer Center at UCLA
  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
  • UCSF Comprehensive Cancer Center
  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
  • University of Miami Sylvester Comprehensive Cancer Center
  • Veterans Affairs Medical Center - Tampa (Haley)
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  • University of Chicago Cancer Research Center
  • American Health Network - North Meridian
  • Greenebaum Cancer Center at University of Maryland Medical Center
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • Nevada Cancer Institute
  • New Mexico Cancer Care Alliance
  • Roswell Park Cancer Institute
  • New York Medical College
  • Duke Comprehensive Cancer Center
  • Brody School of Medicine at East Carolina University
  • Riverside Methodist Hospital Cancer Care
  • Penn State Cancer Institute at Milton S. Hershey Medical Center
  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
  • Hollings Cancer Center at Medical University of South Carolina
  • Vanderbilt-Ingram Cancer Center
  • M.D. Anderson Cancer Center at University of Texas
  • Cliniques Universitaires Saint-Luc
  • U.Z. Gasthuisberg
  • CHU Charleroi - Site Vesale
  • Vancouver Hospital and Health Science Center
  • Saint John Regional Hospital
  • Memorial University of Newfoundland
  • Capital District Health Authority Center for Clinical Research
  • Ottawa Hospital Regional Cancer Centre - General Campus
  • Princess Margaret Hospital
  • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
  • Hopital Edouard Herriot
  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
  • CHR Hotel Dieu
  • Hopital Haut Leveque
  • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
  • Medizinische Universitaetsklinik I at the University of Cologne
  • Universitaetsfrauenklinik Frankfurt
  • Universitatsklinikum Heidelberg
  • Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
  • Klinikum der Universitaet Muenchen - Grosshadern Campus
  • University Wurzburg
  • Evaggelismos Hospital
  • University of Patras Medical School
  • University Medical Center Groningen
  • Medical University of Gdansk
  • Medical University of Lodz
  • Centrum Onkologii Ziemi Lubelskiez
  • Wojskowy Instytut Medyczny
  • Institute of Haematology and Blood Transfusion
  • Clinical Centre of Serbia
  • Clinical Centre Nis
  • Clinic Centre Novi Sad
  • Birmingham Heartlands Hospital
  • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
  • Leicester Royal Infirmary
  • King's College Hospital
  • Manchester Royal Infirmary
  • University Hospital of Wales

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Induction therapy arm I

Induction therapy arm II

Arm Description

Patients receive cytarabine IV continuously on days 1-3 and VNP40101M IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine).

Patients receive cytarabine as in arm I and placebo IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine).

Outcomes

Primary Outcome Measures

Overall response rate

Secondary Outcome Measures

Time to tumor progression
Duration of response
Overall response
Toxicity

Full Information

First Posted
June 2, 2005
Last Updated
November 5, 2013
Sponsor
Vion Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00112554
Brief Title
Cytarabine With or Without VNP40101M in Treating Patients With Relapsed Acute Myeloid Leukemia
Official Title
A Phase III Randomized of Cloretazine™ (VNP40101M) and Cytosine Arabinoside (AraC) in Patients With Acute Myeloid Leukemia in First Relapse
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Vion Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cytarabine and VNP40101M, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This randomized phase III trial is studying cytarabine and VNP40101M to see how well they work compared to cytarabine alone in treating patients with relapsed acute myeloid leukemia.
Detailed Description
OBJECTIVES: Primary Compare the complete response (CR) and CR (with platelet count < 100,000/mm^3 but ≥ 20,000/mm^3 [transfusion independent for ≥ 7 consecutive days]) (CRp) rates in patients with acute myeloid leukemia in first relapse treated with cytarabine with vs without VNP40101M. Secondary Compare time to progression in patients treated with these regimens. Compare duration of response in patients treated with these regimens. Compare the survival of patients treated with these regimens. Compare the toxicity of these regimens in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel group, multicenter study. Patients are stratified according to age (< 60 years vs ≥ 60 years) and duration of first complete response (CR) or CR (with platelet count < 100,000/mm³ but ≥ 20,000/mm³ [transfusion independent for ≥ 7 consecutive days]) (CRp) (< 12 months vs ≥ 12 months). Induction therapy: Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive cytarabine IV continuously on days 1-3 and VNP40101M IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine). Arm II: Patients receive cytarabine as in arm I and placebo IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine). In both arms, patients demonstrating at least 20% reduction of blasts in bone marrow (based on total cellularity and percent blasts) after course 1 may receive 1 additional course of induction therapy between days 35-60 in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp after 1 or 2 courses of induction therapy proceed to consolidation therapy. Consolidation therapy: Beginning 6 weeks after initial documentation of CR or CRp, patients receive 1 course of consolidation therapy, as per induction therapy, according to their randomized treatment arm. These patients may then proceed to other consolidation, maintenance, and/or intensification therapy (including stem cell transplantation) off study at the discretion of the physician. After completion of study treatment, patients are followed monthly for 6 months, every 2 months for 6 months, and then every 3 months for 2 years. PROJECTED ACCRUAL: A total of 420 patients (280 in arm I and 140 in arm II) will be accrued for this study within 24-30 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), recurrent adult acute myeloid leukemia, adult acute basophilic leukemia, adult acute eosinophilic leukemia, adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Induction therapy arm I
Arm Type
Experimental
Arm Description
Patients receive cytarabine IV continuously on days 1-3 and VNP40101M IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine).
Arm Title
Induction therapy arm II
Arm Type
Active Comparator
Arm Description
Patients receive cytarabine as in arm I and placebo IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine).
Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
laromustine
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Overall response rate
Secondary Outcome Measure Information:
Title
Time to tumor progression
Title
Duration of response
Title
Overall response
Title
Toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed acute myeloid leukemia (AML) Any WHO classification, excluding acute promyelocytic leukemia At least 10% blasts by bone marrow aspirate and/or biopsy In first relapse after achieving a first complete response (CR) OR CR (with platelet count < 100,000/mm³ but ≥ 20,000/mm³ [transfusion independent for ≥ 7 consecutive days]) (CRp) that lasted ≥ 3 months but ≤ 24 months after completion of the initial induction regimen Relapse confirmed by recurrence of blasts in peripheral blood, bone marrow histopathology, and/or histologically confirmed CNS or extramedullary disease PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic See Disease Characteristics Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST ≤ 3 times ULN Chronic hepatitis allowed Renal Creatinine ≤ 2.0 mg/dL Cardiovascular No myocardial infarction within the past 3 months No uncontrolled arrhythmias No uncontrolled congestive heart failure Pulmonary No severe chronic obstructive pulmonary disease No requirement for supplemental oxygen at rest Immunologic No uncontrolled active infection Infections that are controlled and under active treatment with antibiotics allowed No evidence of invasive fungal infection by blood or tissue cultures Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study treatment No clinical evidence of another active malignancy by tumor marker, pathology, or radiologic studies No other severe medical condition that would preclude study treatment PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy At least 12 hours since prior hydroxyurea Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other No prior treatment while in first relapse except hydroxyurea No other concurrent standard or investigational treatment for AML No concurrent disulfiram (Antabuse®)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonny L. Johnson, RN, MSN
Organizational Affiliation
Vion Pharmaceuticals
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089-9181
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
University of Miami Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Veterans Affairs Medical Center - Tampa (Haley)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
American Health Network - North Meridian
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Greenebaum Cancer Center at University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Nevada Cancer Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
New Mexico Cancer Care Alliance
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Brody School of Medicine at East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
Riverside Methodist Hospital Cancer Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214-3998
Country
United States
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
Facility Name
M.D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
CHU Charleroi - Site Vesale
City
Montigny-le-Tilleul
ZIP/Postal Code
6110
Country
Belgium
Facility Name
Vancouver Hospital and Health Science Center
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E3
Country
Canada
Facility Name
Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Memorial University of Newfoundland
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Capital District Health Authority Center for Clinical Research
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Ottawa Hospital Regional Cancer Centre - General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Hopital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
CHR Hotel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
D-12200
Country
Germany
Facility Name
Medizinische Universitaetsklinik I at the University of Cologne
City
Cologne
ZIP/Postal Code
D-50924
Country
Germany
Facility Name
Universitaetsfrauenklinik Frankfurt
City
Frankfurt
ZIP/Postal Code
D-60596
Country
Germany
Facility Name
Universitatsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
D-69115
Country
Germany
Facility Name
Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
City
Muenster
ZIP/Postal Code
D-48149
Country
Germany
Facility Name
Klinikum der Universitaet Muenchen - Grosshadern Campus
City
Munich
ZIP/Postal Code
D-81377
Country
Germany
Facility Name
University Wurzburg
City
Wurzburg
ZIP/Postal Code
D-97070
Country
Germany
Facility Name
Evaggelismos Hospital
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
University of Patras Medical School
City
Rio Patras
ZIP/Postal Code
GR-26500
Country
Greece
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Medical University of Gdansk
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Medical University of Lodz
City
Lodz
ZIP/Postal Code
90-419
Country
Poland
Facility Name
Centrum Onkologii Ziemi Lubelskiez
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Wojskowy Instytut Medyczny
City
Warsaw
ZIP/Postal Code
00-909
Country
Poland
Facility Name
Institute of Haematology and Blood Transfusion
City
Warsaw
ZIP/Postal Code
00-957
Country
Poland
Facility Name
Clinical Centre of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Centre Nis
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Clinic Centre Novi Sad
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
State/Province
England
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
King's College Hospital
City
London
State/Province
England
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Manchester Royal Infirmary
City
Manchester
State/Province
England
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19710500
Citation
Giles F, Vey N, DeAngelo D, Seiter K, Stock W, Stuart R, Boskovic D, Pigneux A, Tallman M, Brandwein J, Kell J, Robak T, Staib P, Thomas X, Cahill A, Albitar M, O'Brien S. Phase 3 randomized, placebo-controlled, double-blind study of high-dose continuous infusion cytarabine alone or with laromustine (VNP40101M) in patients with acute myeloid leukemia in first relapse. Blood. 2009 Nov 5;114(19):4027-33. doi: 10.1182/blood-2009-06-229351. Epub 2009 Aug 26.
Results Reference
result
Citation
Giles FJ, Stock W, Vey N, et al.: A double blind placebo-controlled randomized phase III study of high dose continuous infusion cytosine arabinoside (araC) with or without cloretazine in patients with first relapse of acute myeloid leukemia (AML). [Abstract] Blood 108 (11): A-1970, 2006.
Results Reference
result

Learn more about this trial

Cytarabine With or Without VNP40101M in Treating Patients With Relapsed Acute Myeloid Leukemia

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