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Adult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesPhase 2NCT01548911

Gemtuzumab Ozogamicin in Treating Patients With Acute Myeloid Leukemia

A Phase 2 study testing gemtuzumab ozogamicin and laboratory biomarker analysis in people with Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Del(5q), run by Wake Forest University Health Sciences.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This clinical trial studies the side effects of gemtuzumab ozogamicin and how well it works in treating patients with acute myeloid leukemia. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
gemtuzumab ozogamicin and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
May 2012to Sep 2013
Phase
Phase 2
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

Who may be able to join

  • Patients must have confirmed relapsed or refractory acute myeloid leukemia and not a candidate for standard induction treatment after daunorubicin and cytosine arabinoside OR acute promyelocytic leukemia relapsed after all-trans retinoic acid (ATRA) or Arsenic trioxide therapy
  • Patients must have an initial diagnosis of acute myeloid leukemia or biphenotypic acute leukemia
  • Patients must have CD33 positivity of >= 30%
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 3
  • Karnofsky > 60%
  • Total bilirubin within normal institutional limits
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  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2 X institutional upper limit of normal
  • Creatinine within normal institutional limits OR creatinine clearance >= 30 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • The effects of Mylotarg on the developing human fetus are unknown; for this reason and because Mylotarg class agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Patients may not be receiving any other investigational agents for leukemia
  • Patients with known untreated Hepatitis C because veno-occlusive disease and liver enzyme abnormalities have been associated with Mylotarg
  • Uncontrolled intercurrent illness including, but not limited to active liver disease, ongoing or active sepsis requiring vasopressors or mechanical ventilation, symptomatic congestive heart failure, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study because Mylotarg is a Class D agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Mylotarg, breastfeeding should be discontinued if the mother is treated with Mylotarg
  • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with Mylotarg; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
  • Congestive Heart Failure (CHF) with an ejection fraction < 30%
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  • Glomerular filtration rate (GFR) < 30ml/min
  • Active central nervous system (CNS) involvement of leukemia
  • Philadelphia chromosome + acute lymphoblastic leukemia (ALL)
  • Prior hematopoietic transplant in last 3 months

About this study

Official title: Safety and Efficacy of Gemtuzumab Ozogamicin (Mylotarg®) as for Treatment of Patients With CD33-Positive Acute Myeloid Leukemia (AML)

This clinical trial studies the side effects of gemtuzumab ozogamicin and how well it works in treating patients with acute myeloid leukemia. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them

Read the detailed description

PRIMARY OBJECTIVES:

  1. To study safety and efficacy single agent Gemtuzumab Ozogamicin (Mylotarg®) as induction therapy for patients with Acute Myeloid Leukemia (AML) who have relapsed after standard treatments or who are not candidates for standard consolidation treatment after Daunorubicin and cytosine arabinoside.

SECONDARY OBJECTIVES:

  1. To correlate morbidity and mortality with the use of gemtuzumab (gemtuzumab ozogamicin) to specific subtypes of leukemia.

II. To correlate gemtuzumab response to degree of cluster of differentiation (CD) 33 positivity.

III. To correlate FMS-Related Tyrosine Kinase 3 (FLT 3)/nucleophosmin (NPM) status and CD 33 positivity to gemtuzumab response.

IV. To document incidence of sinusoidal obstruction syndrome with the use of gemtuzumab.

OUTLINE:

Patients receive gemtuzumab ozogamicin intravenously (IV) over 2 hours on days 1 and 15. Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up monthly for 1 year.

Being tested
gemtuzumab ozogamicin, laboratory biomarker analysis
Medical subject headings
Congenital Abnormalities, Leukemia, Promyelocytic, Acute, Leukemia, Myeloid, Acute

What participants receive

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

  • gemtuzumab ozogamicinDrug

    Also called Calicheamicin-Conjugated Humanized Anti-CD33 Monoclonal Antibody, CDP-771, CMA-676, Mylotarg

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT01548911
Study groupRoleWhat they receive
Treatment (monoclonal antibody therapy)ExperimentalPatients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15. Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: gemtuzumab ozogamicin; Other: laboratory biomarker analysis

What is being measured

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

  1. Rate of serious adverse events

    95% confidence interval will be calculated. Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

    Measured: Approximately 1 year

Secondary outcomes (5)

  1. Overall response, defined as complete remission (CR) and CR with incomplete platelet recovery (CRp)

    Measured: At 28 days

  2. Safety analysis of gemtuzumab ozogamicin as induction therapy for patients with relapsed AML

    Adverse event frequency and severity

    Measured: Approximately 1 year

  3. Overall survival (OS)

    Measured: Approximately 1 year

  4. Event-free survival (EFS)

    Measured: Approximately 1 year

  5. Disease free survival (DFS)

    Measured: Approximately 1 year

Timeline

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

  1. First posted8 Mar 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionSep 2013
  4. Study completionSep 2013

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01548911
Sponsor's protocol ID
IRB00019491
Other IDs
NCI-2012-00127, CCCWFU 22311
Status last verified
Jun 2018
First submitted
14 Feb 2012
Last updated
2 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemtuzumab ozogamicin and laboratory biomarker analysis in people with Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Del(5q), run by Wake Forest University Health Sciences.

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

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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?

Rate of serious adverse events (time frame: Approximately 1 year). 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 NCT01548911.

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 2 Jul 2018.

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