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LeukemiaPhase 2NCT00017589

Oblimersen and Gemtuzumab Ozogamicin in Treating Older Patients With Relapsed Acute Myeloid Leukemia

A Phase 2 study testing oblimersen sodium and gemtuzumab ozogamicin in people with Leukemia, run by Genta Incorporated at 1 site in United States.

Completed

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

Official record
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Trial summary

RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Oblimersen may help gemtuzumab ozogamicin kill more cancer cells by making cancer cells more sensitive to the drug. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Leukemia
What is being tested?
oblimersen sodium and gemtuzumab ozogamicin
How many people
Not given
Where
1 siteUnited States
Study dates
Dec 2000to May 2006
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed CD33+ acute myeloid leukemia (AML)
  • In first relapse from chemotherapy
  • Complete response lasting at least 3 months before relapse
  • No CNS leukemia
  • No secondary leukemia or history of antecedent hematologic disorder prior to initial onset of AML (e.g., myelodysplasia)

PATIENT CHARACTERISTICS:

Age:

  • 60 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC less than 30,000/mm^3
  • No bleeding or coagulation disorder except disease-related disseminated intravascular coagulation

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • PT and PTT no greater than 1.5 times upper limit of normal OR
  • INR no greater than 1.3
  • No history of chronic hepatitis or cirrhosis

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • No uncontrolled congestive heart failure
  • No New York Heart Association class III or IV heart disease

Pulmonary:

  • No severe pulmonary disease

Other:

  • HIV negative
  • No other concurrent medical disease that would preclude study entry
  • No known hypersensitivity to phosphorothioate-containing oligonucleotides, gemtuzumab ozogamicin or any of its components, E. coli protein, or any product produced in E. coli
  • No other concurrent malignancy
  • No known human anti-human antibodies
  • No uncontrolled seizure disorder
  • No active uncontrolled infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior allogeneic or autologous stem cell transplantation
  • No prior therapy with an anti-CD33 antibody (e.g., gemtuzumab ozogamicin or M195)

Chemotherapy:

  • See Disease Characteristics
  • At least 2 weeks since prior cancer chemotherapy except intrathecal chemotherapy or hydroxyurea

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 2 weeks since prior systemic radiotherapy

Surgery:

  • At least 2 weeks since prior major surgery
  • No prior organ allograft

Other:

  • At least 3 weeks since prior antileukemic therapy and recovered
  • No other concurrent investigational therapy
  • No concurrent immunosuppressive therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Genta Incorporated

    Berkeley Heights, New Jersey, 07922

Other trials in United States

About this study

Official title: Phase II Study of Genasense (Bcl-2 Antisense) Combined With Mylotarg (Gemtuzumab Ozogamicin) in Elderly Patients With Relapsed Acute Myeloid Leukemia

RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Oblimersen may help gemtuzumab ozogamicin kill more cancer cells by making cancer cells more sensitive to the drug.

PURPOSE: Phase II trial to study the effectiveness of combining oblimersen and gemtuzumab ozogamicin in treating older patients who have relapsed acute myeloid leukemia.

Read the detailed description

OBJECTIVES:

  • Determine the complete response rate of elderly patients with relapsed CD33-positive acute myeloid leukemia treated with oblimersen and gemtuzumab ozogamicin.
  • Determine the overall response rate and duration of response of patients treated with this regimen.
  • Determine the safety of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oblimersen IV continuously on days 1-7 and 15-22 and gemtuzumab ozogamicin IV over 2 hours on days 4 and 18.

Patients are followed monthly for 6 months.

PROJECTED ACCRUAL: A total of 20-100 patients will be accrued for this study within 1 year.

Conditions
Leukemia
Being tested
oblimersen sodium, gemtuzumab ozogamicin
Keywords
recurrent adult acute myeloid leukemia
Medical subject headings
Leukemia, Leukemia, Myeloid, Acute

What participants receive

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

  • oblimersen sodiumBiological

  • gemtuzumab ozogamicinDrug

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startDec 2000
  3. Study completionMay 2006

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00017589
Sponsor's protocol ID
CDR0000068721
Other IDs
GENTA-GA210, UCCRC-10928
Status last verified
Apr 2003
First submitted
6 Jun 2001
Last updated
6 Jan 2014
Results posted
No

Publications

  • Moore J, Seiter K, Kolitz J, Stock W, Giles F, Kalaycio M, Zenk D, Marcucci G. A Phase II study of Bcl-2 antisense (oblimersen sodium) combined with gemtuzumab ozogamicin in older patients with acute myeloid leukemia in first relapse. Leuk Res. 2006 Jul;30(7):777-83. doi: 10.1016/j.leukres.2005.10.025. Epub 2006 May 26.

    PubMed 16730060

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing oblimersen sodium and gemtuzumab ozogamicin in people with Leukemia, run by Genta Incorporated at 1 site in United States.

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 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 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 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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00017589, which also lists 1 linked publication.

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 Jan 2014.

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