Clinical trial NCT00003131: CMA-676 in Treating Patients With Acute Myeloid Leukemia in First Relapse
Official title: A Study of the Efficacy and Safety of CMA-676 as Single Agent Treatment of Patients With Acute Myeloid Leukemia (AML) in First Relapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia
Keywords: recurrent adult acute myeloid leukemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2004-08-24
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of CMA-676 in treating patients with acute myeloid leukemia in first relapse.

Detailed description: OBJECTIVES: I. Assess the efficacy of CMA-676 in terms of the number of patients with acute myeloid leukemia attaining a complete remission. II. Assess the safety of CMA-676 in this patient population.

OUTLINE: This is an open label, single arm, multicenter study. Patients receive CMA-676 IV over 2 hours on day 1. Patients may receive 1 additional dose of therapy 15 to 28 days later. Patients who achieve complete or morphologic remission are followed for an additional 6 months and every 3-6 months thereafter until relapse and/or death.

PROJECTED ACCRUAL: 55 evaluable patients will be accrued. Enrollment will then be extended for up to an additional 55 patients.

Eligibility criteria: DISEASE CHARACTERISTICS: Histologically diagnosed CD33 positive acute myeloid leukemia (AML) in first relapse At least 6 months of complete remission No CNS leukemia No AML secondary to exposure to chemotherapy or toxins

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC less than 30,000/mm3 at time of CMA-676 administration Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No severe cardiac disease Pulmonary: No severe pulmonary disease Other: Not pregnant or nursing Fertile patients must use an effective method of contraception Not known to be HIV positive No prior myelodysplastic syndrome No other active malignancy No uncontrolled infections Able to obtain bone marrow aspirate

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplantation No prior anti-CD33 antibody therapy Chemotherapy: No prior chemotherapy for AML in first relapse except hydroxyurea At least 24 hours since prior hydroxyurea Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 4 weeks since prior investigational agents

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Duarte
country: United States
facility: Beckman Research Institute, City of Hope
state: California
city: Miami
country: United States
facility: Sylvester Cancer Center, University of Miami
state: Florida
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
city: Baltimore
country: United States
facility: Marlene & Stewart Greenebaum Cancer Center, University of Maryland
state: Maryland
city: Boston
country: United States
facility: New England Medical Center Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital - Cornell Campus
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Mark Stanley Berger, MD
role: STUDY_CHAIR
References:
citation: Lang K, Menzin J, Earle CC, Mallick R. Outcomes in patients treated with gemtuzumab ozogamicin for relapsed acute myelogenous leukemia. Am J Health Syst Pharm. 2002 May 15;59(10):941-8. doi: 10.1093/ajhp/59.10.941.
citation: Hibma J, Knight B. Population Pharmacokinetic Modeling of Gemtuzumab Ozogamicin in Adult Patients with Acute Myeloid Leukemia. Clin Pharmacokinet. 2019 Mar;58(3):335-347. doi: 10.1007/s40262-018-0699-5.