CMA-676 in Treating Older Patients With Acute Myeloid Leukemia in First Relapse
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia
Intervention: gemtuzumab ozogamicin (Drug); chemotherapy (Procedure)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Wyeth
Official(s) and/or principal investigator(s):
Mark Stanley Berger, MD, Study Chair, Affiliation: Wyeth
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 older patients who
have acute myeloid leukemia that has recurred for the first time following at least 3 months
of complete remission.
Official title: A Study of the Safety of CMA-676 in Treatment of Elderly Patients With Acute Myeloid Leukemia (AML) in First Relapse
Study design: Treatment
OBJECTIVES: I. Assess the efficacy of CMA-676 in elderly patients with acute myeloid leukemia
in first relapse in terms of the number of patients 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 1 course of
CMA-676 IV over 2 hours on day 1 followed by a 6 hour observation period. Patients may
receive 1 additional course of therapy 15 to 28 days later. There is a 28 day follow-up
period after the last dose of study medication. Patients are followed for an additional 6
months, then every 3 months for 18 months, and then every 6 months until relapse and/or
PROJECTED ACCRUAL: A total of 23-55 patients will be accrued for this study within 12 months.
Enrollment will then be extended for up to an additional 55 patients.
Minimum age: 60 Years.
Maximum age: N/A.
DISEASE CHARACTERISTICS: CD33 positive acute myeloid leukemia in first relapse At least 3
months of complete remission No history of a secondary leukemia evolving from a known prior
myelodysplastic syndrome or resulting from exposure to chemotherapy or toxins No active CNS
PATIENT CHARACTERISTICS: Age: 60 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 2. 0 mg/dL Renal: Creatinine no greater than 3. 0 mg/dL
Cardiovascular: No uncontrolled cardiac disease Pulmonary: No uncontrolled pulmonary
disease Other: No other active malignancy No uncontrolled, life-threatening infections Able
to obtain bone marrow aspirate HIV negative
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow and peripheral blood stem
cells transplantation No prior anti-CD33 antibody therapy Chemotherapy: Prior cytotoxic
chemotherapy for AML allowed No prior chemotherapy for AML in first relapse except
hydroxyurea At least 24 hours since prior hydroxyurea Recovered from prior antineoplastic
therapy (except alopecia) No concurrent cytotoxic chemotherapy Endocrine therapy: No
concurrent immunosuppressive therapy Radiotherapy: Not specified Surgery: Not specified
Other: At least 4 weeks since prior investigational agents No other concurrent antileukemic
Locations and Contacts
Arizona Cancer Center, Tucson, Arizona 85724, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California 90095-1781, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois 60611, United States
University of Chicago Cancer Research Center, Chicago, Illinois 60637, United States
New England Medical Center Hospital, Boston, Massachusetts 02111, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201, United States
Long Island Jewish Medical Center, New Hyde Park, New York 11040, United States
New York Presbyterian Hospital - Cornell Campus, New York, New York 10021, United States
State University of New York Health Sciences Center - Stony Brook, Stony Brook, New York 11790-9832, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania 19104, United States
Clinical trial summary from the National Cancer Institute's PDQ® database
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.
Larson RA, Boogaerts M, Estey E, Karanes C, Stadtmauer EA, Sievers EL, Mineur P, Bennett JM, Berger MS, Eten CB, Munteanu M, Loken MR, Van Dongen JJ, Bernstein ID, Appelbaum FR; Mylotarg Study Group. Antibody-targeted chemotherapy of older patients with acute myeloid leukemia in first relapse using Mylotarg (gemtuzumab ozogamicin). Leukemia. 2002 Sep;16(9):1627-36.
Sievers EL, Larson RA, Stadtmauer EA, Estey E, Lowenberg B, Dombret H, Karanes C, Theobald M, Bennett JM, Sherman ML, Berger MS, Eten CB, Loken MR, van Dongen JJ, Bernstein ID, Appelbaum FR; Mylotarg Study Group. Efficacy and safety of gemtuzumab ozogamicin in patients with CD33-positive acute myeloid leukemia in first relapse. J Clin Oncol. 2001 Jul 1;19(13):3244-54.
Starting date: March 1998
Last updated: May 23, 2008