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


Phase 2
60 Years
N/A
Open (Enrolling)
Both
Leukemia

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Stanley R. Frankel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Genta Incorporated

Authority:

United States: Federal Government

Study ID:

CDR0000068721

NCT ID:

NCT00017589

Start Date:

December 2000

Completion Date:

Related Keywords:

  • Leukemia
  • recurrent adult acute myeloid leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Genta IncorporatedBerkeley Heights, New Jersey  07922