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LeukemiaPhase 3NCT00112554

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

A Phase 3 study testing cytarabine and laromustine in people with Leukemia, run by Vion Pharmaceuticals at 62 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia
What is being tested?
cytarabine and laromustine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
420 participants
Where
62 sitesin 10 countries
Study dates
Mar 2005to Mar 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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®)

Trial locations and contacts

62 sites in 10 countries.

62 sites in 10 countries

United States24 sites

  • New Mexico Cancer Care Alliance

    Albuquerque, New Mexico, 87106

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Brody School of Medicine at East Carolina University

    Greenville, North Carolina, 27858

  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • M.D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • American Health Network - North Meridian

    Indianapolis, Indiana, 46260

  • Nevada Cancer Institute

    Las Vegas, Nevada, 89135

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1781

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

    Orange, California, 92868

  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94115

  • Veterans Affairs Medical Center - Tampa (Haley)

    Tampa, Florida, 33612

  • New York Medical College

    Valhalla, New York, 10595

Other trials in United States

Germany7 sites

  • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, D-12200

  • Medizinische Universitaetsklinik I at the University of Cologne

    Cologne, D-50924

  • Universitaetsfrauenklinik Frankfurt

    Frankfurt, D-60596

  • Universitatsklinikum Heidelberg

    Heidelberg, D-69115

  • Klinikum der Universitaet Muenchen - Grosshadern Campus

    Munich, D-81377

  • Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster

    Münster, D-48149

  • University Wurzburg

    Würzburg, D-97070

Other trials in Germany

Canada6 sites

  • Capital District Health Authority Center for Clinical Research

    Halifax, Nova Scotia, B3H 1V7

  • Ottawa Hospital Regional Cancer Centre - General Campus

    Ottawa, Ontario, K1H 8L6

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Memorial University of Newfoundland

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • Vancouver Hospital and Health Science Center

    Vancouver, British Columbia, V5Z 4E3

Other trials in Canada

United Kingdom6 sites

  • Birmingham Heartlands Hospital

    Birmingham, England, B9 5SS

  • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

    Cambridge, England, CB2 2QQ

  • University Hospital of Wales

    Cardiff, Wales, CF14 4XW

  • Leicester Royal Infirmary

    Leicester, England, LE1 5WW

  • King's College Hospital

    London, England, SE5 9RS

  • Manchester Royal Infirmary

    Manchester, England, M13 9WL

Other trials in United Kingdom

France5 sites

  • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • Hopital Edouard Herriot

    Lyon, 69437

  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

    Marseille, 13273

  • CHR Hotel Dieu

    Nantes, 44093

  • Hopital Haut Leveque

    Pessac, 33604

Other trials in France

Poland5 sites

  • Medical University of Gdansk

    Gdansk, 80-211

  • Medical University of Lodz

    Lodz, 90-419

  • Centrum Onkologii Ziemi Lubelskiez

    Lublin, 20-954

  • Wojskowy Instytut Medyczny

    Warsaw, 00-909

  • Institute of Haematology and Blood Transfusion

    Warsaw, 00-957

Other trials in Poland

Belgium3 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • U.Z. Gasthuisberg

    Leuven, B-3000

  • CHU Charleroi - Site Vesale

    Montigny-le-Tilleul, 6110

Other trials in Belgium

Serbia3 sites

  • Clinical Centre of Serbia

    Belgrade, 11000

  • Clinical Centre Nis

    Niš, 18000

  • Clinic Centre Novi Sad

    Novi Sad, 21000

Other trials in Serbia

Greece2 sites

  • Evaggelismos Hospital

    Athens, 10676

  • University of Patras Medical School

    Rio Patras, GR-26500

Other trials in Greece

Netherlands1 site

  • University Medical Center Groningen

    Groningen, 9713 GZ

Other trials in Netherlands

About this study

Official title: A Phase III Randomized of Cloretazine™ (VNP40101M) and Cytosine Arabinoside (AraC) in Patients With Acute Myeloid Leukemia in First Relapse

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.

Read the 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.

Conditions
Leukemia
Being tested
cytarabine, laromustine, placebo
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)
Medical subject headings
Leukemia, Congenital Abnormalities, Leukemia, Myeloid, Acute, Leukemia, Basophilic, Acute, Leukemia, Eosinophilic, Acute, Leukemia, Erythroblastic, Acute, Leukemia, Megakaryoblastic, Acute, Leukemia, Monocytic, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cytarabineDrug

    Given IV

  • laromustineDrug

    Given IV

  • placeboOther

    Given IV

Study groups in NCT00112554
Study groupRoleWhat they receive
Induction therapy arm IExperimentalPatients 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).
Receives: Drug: cytarabine; Drug: laromustine
Induction therapy arm IIActive comparatorPatients 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).
Receives: Drug: cytarabine; Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate

Secondary outcomes (4)

  1. Time to tumor progression

  2. Duration of response

  3. Overall response

  4. Toxicity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2005 (estimated)
  2. Study startMar 2005
  3. Primary completionMar 2008
  4. Study completionMar 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
Double blind
Enrolment
420 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00112554
Sponsor's protocol ID
CDR0000430677
Other IDs
VION-CLI-037
Status last verified
Feb 2009
First submitted
2 Jun 2005
Last updated
6 Nov 2013
Results posted
No

Publications

  • 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.

    PubMed 19710500

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cytarabine and laromustine in people with Leukemia, run by Vion Pharmaceuticals at 62 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, Germany, Canada, United Kingdom, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00112554, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2013.

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