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Gemtuzumab Ozogamicin (CMA-676) Followed or Not by Intensive Chemotherapy as Initial Treatment for Elderly Patients With Acute Myeloid Leukemia: An EORTC-LG Pilot Phase II Study


Phase 2
61 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

Gemtuzumab Ozogamicin (CMA-676) Followed or Not by Intensive Chemotherapy as Initial Treatment for Elderly Patients With Acute Myeloid Leukemia: An EORTC-LG Pilot Phase II Study


OBJECTIVES: I. Determine the feasibility, toxicity, and antileukemic activity of gemtuzumab
ozogamicin (CMA-676) with or without mitoxantrone, etoposide, cytarabine, and idarubicin in
elderly patients with acute myeloid leukemia.

OUTLINE: This is a multicenter study. Patients are stratified according to risk (standard
risk, defined as age 61-75 and WHO performance status 0-1 vs poor risk, defined as over 75
years and WHO performance status 0-2 OR under 76 years and WHO performance status 2).
Frontline therapy: Patients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15.
Stratum I (Standard risk patients): Patients with disease progression at any time during
frontline therapy may begin induction therapy immediately. Induction therapy begins 7-10
days after response assessment regardless of response and in the absence of unacceptable
toxicity. Stratum II (Poor risk patients): Patients experiencing complete remission with or
without platelet recovery will begin consolidation therapy within 4-8 weeks of response
assessment in the absence of unacceptable toxicity. Stratum I Induction therapy: Patients
receive mitoxantrone IV over 30 minutes on days 1, 3 and 5; etoposide IV over 1 hour on days
1-3; and cytarabine IV continuously on days 1-7. Patients experiencing partial response are
given a second induction therapy course. Patients experiencing complete remission with or
without platelet recovery after 1 or 2 induction courses begin consolidation therapy within
4-8 weeks of response assessment in the absence of unacceptable toxicity. Consolidation
therapy: Patients receive idarubicin IV on days 1, 3 and 5; etoposide IV over 1 hour on days
1-3; and cytarabine IV continuously on days 1-5. Stratum II Consolidation therapy: Patients
receive gemtuzumab ozogamicin IV over 2 hours on day 1 and then 1-3 months later. Patients
are followed monthly for 1 year, every 3 months for 2 years, and then every 6 months
thereafter.

PROJECTED ACCRUAL: A total of 45-82 (28-49 for stratum I, and 17-33 for stratum II) patients
will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Diagnosis of primary or secondary acute myeloid leukemia (AML)
Previously untreated At least 20% marrow blasts AML after myelodysplastic syndrome allowed
No leukemia after other myeloproliferative diseases No acute promyelocytic leukemia (M3)
or blastic phase chronic myelogenous leukemia No active CNS leukemia

PATIENT CHARACTERISTICS: Age: 61 and over Performance status: WHO 0-2 Life expectancy: Not
specified Hematopoietic: See Disease Characteristics White blood count no greater than
30,000/mm3 unless reducible to less than 30,000/mm3 by a maximum of 7 days of hydroxyurea
Hepatic: Bilirubin no greater than 3 times upper limit of normal (ULN) Renal: Creatinine
no greater than 3 times ULN Cardiovascular: No severe heart failure that would preclude
study Pulmonary: No severe lung failure that would preclude study Other: No other
concurrent malignancies No active uncontrolled infection No concurrent severe neurological
or psychiatric disease No psychological, familial, sociological or geographical condition
that would preclude compliance with study HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior humanized monoclonal antibody therapy
Chemotherapy: Up to 7 days of prior hydroxyurea allowed At least 24 hours since prior
hydroxyurea No other prior chemotherapy for AML Endocrine therapy: No more than 7 days of
prior corticosteroids No other prior endocrine therapy Radiotherapy: No prior radiotherapy
Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Sergio Amadori, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ospedale Sant' Eugenio

Authority:

United States: Federal Government

Study ID:

EORTC-06993

NCT ID:

NCT00006122

Start Date:

June 2000

Completion Date:

Related Keywords:

  • Leukemia
  • untreated adult acute myeloid leukemia
  • adult acute erythroid leukemia (M6)
  • 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 megakaryoblastic leukemia (M7)
  • secondary acute myeloid leukemia
  • adult acute monocytic leukemia (M5b)
  • adult acute minimally differentiated myeloid leukemia (M0)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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