- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006084
Monoclonal Antibody in Treating Patients With Acute Myelogenous Leukemia
Phase II, Open-Label Study of HuM195 (Humanized Anti-CD33 Monoclonal Antibody) Administered to Patients With Acute Myelogenous Leukemia (AML) Who Are Documented Regimen Failures (RF) of the Control Arm of Study 195-301
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody in treating patients who have acute myelogenous leukemia that did not respond to standard treatment given in clinical trial PDL 195-301.
Study Overview
Detailed Description
OBJECTIVES: I. Determine the safety and efficacy of monoclonal antibody HuG1-M195 as demonstrated by frequency of complete remission (CR) in patients with acute myelogenous leukemia with regimen failure on the control arm of PDL Study 195-301. II. Determine additional evidence of clinical benefit of this treatment as demonstrated by frequency of partial remission (PR), durations of CR and PR, and progression free and overall survival in these patients.
OUTLINE: This is a multicenter study. Patients receive monoclonal antibody HuG1-M195 (MOAB HuM195) IV over 4 hours on days 1-4 every 2 weeks for 4 courses. Patients without disease progression after completion of course 4 continue to receive MOAB HuM195 as above. Treatment repeats every month for a maximum of 8 additional courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months.
PROJECTED ACCRUAL: A maximum of 100 patients will be accrued for this study.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Histologically proven acute myelogenous leukemia (AML) with documented regimen failure on the control arm (standard chemotherapy alone) of PDL study 195-301 Regimen failure, defined as: Bone marrow blasts greater than 10% and rising (according to 2 sequential bone marrow samples obtained 1-2 weeks apart) OR Bone marrow blasts greater than 20% Must enroll within 2 weeks after documented regimen failure No active CNS leukemia
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 2.0 mg/dL (unless related to Gilbert's disease or due to leukemic infiltration) SGOT and SGPT no greater than 4 times upper limit of normal (unless related to AML) Renal: Creatinine less than 2.0 mg/dL (unless related to AML) Cardiovascular: Left ventricular function normal No significant cardiovascular disease (e.g., unstable cardiac arrhythmias or unstable angina pectoris) No myocardial infarction within the past 6 months No New York Heart Association class III or IV heart disease No active ischemia by EKG Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No active serious infection not controlled by antimicrobial therapy No other active malignancy requiring therapy Medically stable No significant organ dysfunction
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy, including bone marrow transplantation, for AML after termination from PDL Study 195-301 No other concurrent biologic therapy for AML Chemotherapy: See Disease Characteristics No additional chemotherapy for AML after termination from PDL Study 195-301 No concurrent chemotherapy for AML Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for AML after termination from PDL Study 195-301 No concurrent radiotherapy for AML Surgery: Not specified Other: No other concurrent experimental therapy for AML
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- secondary acute myeloid leukemia
- recurrent adult acute myeloid leukemia
- adult acute erythroid leukemia (M6)
- adult acute megakaryoblastic leukemia (M7)
- adult acute minimally differentiated myeloid leukemia (M0)
- adult acute monoblastic leukemia (M5a)
- adult acute monocytic leukemia (M5b)
- adult acute myeloblastic leukemia with maturation (M2)
- adult acute myeloblastic leukemia without maturation (M1)
- adult acute myelomonocytic leukemia (M4)
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000068076
- P30CA016042 (U.S. NIH Grant/Contract)
- UCLA-9910096
- PDL-195-302
- NCI-G00-1823
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