NCT00017589

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 2000

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2000

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2001

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

January 6, 2014

Status Verified

April 1, 2003

First QC Date

June 6, 2001

Last Update Submit

January 3, 2014

Conditions

Leukemia

Keywords

recurrent adult acute myeloid leukemia

Interventions

oblimersen sodiumBIOLOGICAL
gemtuzumab ozogamicinDRUG

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Genta Incorporated

Berkeley Heights, New Jersey, 07922, United States

Location

Related Publications (1)

  • 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.

    PMID: 16730060RESULT

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Acute

Interventions

oblimersenGemtuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, Myeloid

Intervention Hierarchy (Ancestors)

CalicheamicinsAminoglycosidesGlycosidesCarbohydratesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Stanley R. Frankel, MD

    Genta Incorporated

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 6, 2001

First Posted

January 27, 2003

Study Start

December 1, 2000

Study Completion

May 1, 2006

Last Updated

January 6, 2014

Record last verified: 2003-04

Locations

US(1)