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Phase 1/Phase 2
60 Years
Open (Enrolling)

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Trial Information

Study Groups:

If found to be eligible to take part in this study, participants will be assigned to a study
group based on when joining the study. Up to 4 groups of up to 6 participants will be
enrolled in the Phase I portion of the study, and up to 53 participants will be enrolled in
Phase II.

If enrolled in the Phase I portion, the dose of Lintuzumab-Ac225 received will depend on
when participant joined this study. The first group of participants will receive the lowest
dose level of Lintuzumab-Ac225. Each new group will receive a higher dose of
Lintuzumab-Ac225 than the group before it, if no intolerable side effects were seen. This
will continue until the highest tolerable dose of Lintuzumab-Ac225 is found.

If enrolled in the Phase II portion, participant will receive Lintuzumab-Ac225 at the
highest dose that was tolerated in the Phase I portion.

All participants will receive the same dose level of cytarabine.

Study Drug Administration:

Participants will receive cytarabine as an injection under the skin. This is called a
subcutaneous injection. During the first office visit, participant or a caregiver will be
taught to give these injections at home. Participant will get cytarabine injections 2 times
each day during Days 1-10 of each study cycle. Cycle 1 may last up to 52 days and will
depend on how participant recovers from the Lintuzumab-Ac225. All other cycles will be 28

Participant will receive Lintuzumab-Ac225 by vein over 15-30 minutes at a time point about 4
to 7 days after your last dose of cytarabine in Cycle 1. Participant will receive it a
second time about 4 to 7 days after that.

One (1) day before the second dose of Lintuzumab-Ac225, participant will begin taking lasix
(furosemide) by mouth every day for 10 days. Furosemide is taken to prevent possible damage
to the kidneys.

One (1) day after last dose of furosemide, participant will begin taking spironolactone by
mouth every day for up to 1 year. It is also taken to prevent possible kidney damage.

Inclusion Criteria:

1. Untreated acute myelogenous leukemia (AML), including patients with an antecedent
hematologic disorder or secondary disease. Patients with prior myelodysplastic
syndromes (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 ahve no measurable disease are not undergoing active
therapy, and have a life expectancy of greater than or equal 4 months.

2. Patients age greater than or equal to 60 years who: a. Are unwilling to receive
intensive (e.g. 7+3) chemotherapy, or b. Have poor-risk prognostic factors defined as
antecedent hematologic disorder, prior chemotherapy or chemoradiation therapy (XRT),
abnormal karyotype other than t(8;21), inv16, or t(16;16), any karyotype with
Internal tandem duplications of Flt3 (Flt3-ITD), or presenting white blood count
(WBC) greater than 100K, or c. 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 d. Any
patient age greater than or equal to 70 years.

3. Blast count greater than or equal to 20 percent (World Health Organization (WHO)

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

5. Creatinine less than 2.0 mg/dl

6. Estimated creatinine clearance greater than or equal to 50ml/min.

7. Bilirubin less than or equal to 2.0 mg/dl; aspartate aminotransferase (AST or SGOT)
and alanine aminotransferase (ALT or SGPT) less than or equal to 2.5 times the upper
limits of normal (ULN).

8. Eastern Cooperative Oncology Group (ECOG) Performance status less than or equal to 3.

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
prostate-specific antigen (PSA) levels and are not on active therapy

6. Clinically significant cardiac or pulmonary disease

7. Active central nervous system (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.

8. Psychiatric disorder that would preclude study participation

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) of Lintuzumab-Ac225

Outcome Time Frame:

Cycle 1, up to 52 days

Safety Issue:


Principal Investigator

Farhad Ravandi-Kashani, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

October 2012

Completion Date:

Related Keywords:

  • Leukemia
  • Cytarabine
  • Lintuzumab-Ac225
  • ACTINIUM-225
  • Alpha-Particle-Emitting Immunoconjugates
  • Leukemia



UT MD Anderson Cancer Center Houston, Texas  77030