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

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
oblimersen sodium
gemtuzumab ozogamicin
Sponsored by
Genta Incorporated
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring recurrent adult acute myeloid leukemia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Genta Incorporated

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 6, 2001
Last Updated
January 3, 2014
Sponsor
Genta Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00017589
Brief Title
Oblimersen and Gemtuzumab Ozogamicin in Treating Older Patients With Relapsed Acute Myeloid Leukemia
Official Title
Phase II Study of Genasense (Bcl-2 Antisense) Combined With Mylotarg (Gemtuzumab Ozogamicin) in Elderly Patients With Relapsed Acute Myeloid Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2003
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Genta Incorporated

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
recurrent adult acute myeloid leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
oblimersen sodium
Intervention Type
Drug
Intervention Name(s)
gemtuzumab ozogamicin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanley R. Frankel, MD
Organizational Affiliation
Genta Incorporated
Official's Role
Study Chair
Facility Information:
Facility Name
Genta Incorporated
City
Berkeley Heights
State/Province
New Jersey
ZIP/Postal Code
07922
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16730060
Citation
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.
Results Reference
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Oblimersen and Gemtuzumab Ozogamicin in Treating Older Patients With Relapsed Acute Myeloid Leukemia

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