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A Phase II Trial Combining Gemtuzumab Ozogamicin (Mylotarg) With Cyclosporine for the Treatment of Relapsed Acute Myeloid Leukemia in Adults Over Age 60


Phase 2
60 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

A Phase II Trial Combining Gemtuzumab Ozogamicin (Mylotarg) With Cyclosporine for the Treatment of Relapsed Acute Myeloid Leukemia in Adults Over Age 60


OBJECTIVES:

Primary

- Determine the efficacy of gemtuzumab ozogamicin and cyclosporine, in terms of the
complete remission rate, in older patients with relapsed acute myeloid leukemia.

- Determine the toxicity and pharmacokinetics of this regimen in these patients.

Secondary

- Correlate clinical response with laboratory studies of drug susceptibility in patients
treated with this regimen.

OUTLINE: Patients receive cyclosporine IV continuously over 72 hours on days 1-3 and 15-17.
Eight hours after initiation of each cyclosporine infusion, patients receive gemtuzumab
ozogamicin IV over 2 hours on days 1 and 15. Treatment continues in the absence of disease
progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Morphologically confirmed acute myeloid leukemia (AML) by bone marrow aspirate

- More than 20% blasts by morphologic criteria

- Relapsed disease ≥ 3 months after prior complete remission

- Blasts CD33-positive by flow cytometry

- No primary hematologic disorder that preceded initial presentation with AML

- No documented secondary AML related to prior chemotherapy or toxin exposure

- No acute promyelocytic leukemia (FAB M3)

- Not a candidate for transplant therapy

- No active CNS leukemia

PATIENT CHARACTERISTICS:

Age

- 60 and over

Performance status

- Karnofsky 70-100%

Life expectancy

- Not specified

Hematopoietic

- WBC ≤ 30,000/mm^3 (hydroxyurea allowed)

Hepatic

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST or ALT ≤ 1.5 times ULN

Renal

- Creatinine ≤ 1.5 mg/dL

Other

- HIV negative

- No uncontrolled infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not planning hematopoietic stem cell transplantation immediately after study therapy

Chemotherapy

- See Disease Characteristics

- See Hematopoietic

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- More than 1 month since prior investigational agents

- No other concurrent anticancer therapy

- No administration of any of the following for 24 hours after cyclosporine
administration:

- Diltiazem

- Verapamil

- Erythromycin

- Clarithromycin

- Metoclopramide

- Phenytoin

- Rifampin

- Phenobarbital

- Aminoglycosides

- Amphotericin B

- Vancomycin

- Cimetidine

- Ranitidine

- Trimethoprim/sulfamethoxazole

- Ketoconazole

- Fluconazole

- Itraconazole

- Voriconazole

- Carbamazepine

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy in terms of complete remission rate

Safety Issue:

No

Principal Investigator

Stephen H. Petersdorf, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1820.00

NCT ID:

NCT00089050

Start Date:

May 2004

Completion Date:

March 2006

Related Keywords:

  • Leukemia
  • recurrent adult acute myeloid leukemia
  • adult acute minimally differentiated myeloid leukemia (M0)
  • adult acute myeloblastic leukemia without maturation (M1)
  • adult acute myeloblastic leukemia with maturation (M2)
  • adult acute myelomonocytic leukemia (M4)
  • adult acute monoblastic leukemia (M5a)
  • adult acute monocytic leukemia (M5b)
  • adult erythroleukemia (M6a)
  • adult pure erythroid leukemia (M6b)
  • adult acute megakaryoblastic leukemia (M7)
  • adult acute basophilic leukemia
  • adult acute eosinophilic leukemia
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109