Lintuzumab-Ac225 in Older Acute Myeloid Leukemia (AML) Patients



Status:Active, not recruiting
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:60 - Any
Updated:3/9/2019
Start Date:October 2012
End Date:May 2019

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A Phase I/II Study of Lintuzumab-Ac225 in Older Patients With Untreated Acute Myeloid Leukemia

The study is a multicenter, open label Phase I/II trial.

1. Establish the MTD of fractionated doses of Lintuzumab-Ac225 in combination with low dose
cytosine arabinoside (Low Dose Ara-C, LDAC) (Phase 1 portion)

2. Determine the response rate (CR + CRp + CRi) to fractionated doses of Lintuzumab-Ac225
alone (Phase 2 portion)


Phase 1 Major Inclusion Criteria:

1. Untreated AML, including patients with an antecedent hematologic disorder or secondary
disease. Patients with prior MDS may have received therapy with immunomodulatory
agents or hypomethylating agents for this diagnosis. Patients with other prior cancer
diagnoses are allowed as long as they have no measurable disease, are not undergoing
active therapy, and have a life expectancy of ≥ 4 months.

2. Patients age ≥60 years who:

1. Are unwilling to receive intensive (e.g. 7+3) chemotherapy, or

2. Have poor-risk prognostic factors defined as antecedent hematologic disorder,
prior chemotherapy or XRT, abnormal karyotype other than t(8;21), inv16, or
t(16;16), any karyotype with FLT3-ITD, or presenting WBC>100K, or

3. Have significant comorbidities, that in the judgment of the investigator makes
the subject unsuitable for standard dose induction chemotherapy (e.g.
anthracycline and infusional cytarabine given as 7+3), or;

4. Any patient age ≥ 70 years.

3. Blast count ≥20%

4. Greater than 25% of blasts must be CD33 positive.

5. Adequate renal and hepatic function

6. ECOG ≤ 3

Phase 2 Inclusion Criteria:

1. Untreated AML, including patients with an antecedent hematologic disorder or secondary
disease. Patients with prior MDS may have received therapy with immunomodulatory
agents for this diagnosis.

2. Patients age ≥60 years who:

1. Patients ≥60 years unfit to receive intensive (e.g., 7+3) chemotherapy who have:

- Congestive heart failure or documented cardiomyopathy with an EF ≤50%,
provided that EF ≥35% or,

- Documented pulmonary disease with DLCO ≤65% or FEV1 ≤65%, provided that
patients do not require more than 2 L of oxygen per minute or,

- Documented liver disease with marked elevation of transaminases >3 x ULN or,

- Serum creatinine >1.2 mg/dL

2. Have significant comorbidities, that in the judgment of the investigator makes
the subject unsuitable for standard dose induction chemotherapy (e.g.,
anthracycline and infusional cytarabine given as 7+3); or

3. Any patient age ≥ 75 years.

3. Blast count ≥ 20% (WHO criteria)

4. Greater than 25% of blasts must be CD33 positive.

5. Have a circulating blast count of less than 200/mm3 (control with hydroxyurea or
similar agent is allowed);

6. Creatinine < 2.0 mg/dl

7. Estimated creatinine clearance ≥ 50ml/min

8. Bilirubin ≤ 2.0 mg/dl; AST and ALT < 5.0 times the ULN

9. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2

Exclusion Criteria:

1. Patients with acute promyelocytic leukemia

2. Treatment with chemotherapy or biologic therapy within 3 weeks, except for
hydroxyurea, which must be discontinued prior to treatment on study

3. Treatment with radiation within 6 weeks

4. Active serious infections uncontrolled by antibiotics

5. Active malignancy within 2 years of entry, except previously treated non-melanoma skin
cancer, carcinoma in situ or cervical intraepithelial neoplasia, and organ confined
prostate cancer with no evidence of progressive disease based on PSA levels and are
not on active therapy.

6. Clinically significant cardiac or pulmonary disease

7. Patients with liver cirrhosis

8. Active CNS leukemia. Patients with symptoms of CNS involvement, particularly those
with M4 or M5 subtypes, should undergo lumbar puncture prior to treatment on study to
exclude CNS disease. Symptoms include cranial neuropathies, other neurologic deficits,
and headache.

9. Psychiatric disorder that would preclude study participation
We found this trial at
17
sites
1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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Durham, North Carolina 27710
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Greenville, South Carolina 29607
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100 Medical Plaza Driveway
Los Angeles, California 90024
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8800 W. Doyne Avenue
Milwaukee, Wisconsin 53226
(414) 805-6840
Medical College of Wisconsin Cancer Center Cancer touches everyone in our community, and for many,...
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1514 Jefferson Highway
New Orleans, Louisiana 70121
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1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 646-497-9154
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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1130 Saint Nicholas Avenue
New York, New York 10032
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445 E 69th St
New York, New York 10021
(212) 746-1067
Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
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Rochester, Minnesota 55905
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