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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00017589
• Other study ID #: CDR0000068721
• Secondary ID: GENTA-GA210UCCRC
• Status: Completed
• Phase: Phase 2
• First received: June 6, 2001
• Last updated: January 3, 2014
• Start date: December 2000
• Est. completion date: May 2006

Study information

• Verified date: April 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Biological:
• oblimersen sodium

Drug:
• gemtuzumab ozogamicin

Locations

Country	Name	City	State
United States	Genta Incorporated	Berkeley Heights	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Genta Incorporated

Country where clinical trial is conducted

United States, 

References & 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;3 — View Citation