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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Leukemia

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Christos E. Emmanouilides, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068076

NCT ID:

NCT00006084

Start Date:

February 2001

Completion Date:

Related Keywords:

  • Leukemia
  • recurrent 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

Name

Location
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781