TerminatedNCT00618696Updated Nov 29, 2017

Yttrium Y 90 Anti-CD45 Monoclonal Antibody AHN-12 in Treating Patients With Advanced Leukemia

A Phase 1 interventional study of anti-CD45 monoclonal antibody AHN-12 and yttrium Y 90 anti-CD45 monoclonal antibody AHN-12 in Leukemia and Myelodysplastic Syndromes, sponsored by Masonic Cancer Center, University of Minnesota. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-29.

Sponsored by Masonic Cancer Center, University of Minnesota · Phase 1, Interventional, and Treatment

Why this study was terminated

Replaced with another study

Phase: Phase 1
Study type: Interventional
Enrollment: 4
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

RATIONALE: Monoclonal antibodies can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Radioactive monoclonal antibodies, such as yttrium Y 90 monoclonal antibody, can find cancer cells and either kill them or carry cancer-killing substances to them without harming normal cells.

PURPOSE: This phase I trial is studying the side effects and best dose of a yttrium Y 90 monoclonal antibody and how much radiation is taken in by the organs in the body in treating patients with advanced leukemia or other hematologic disorder.

Read the detailed description

OBJECTIVES:

Primary

To establish that a dose of 150 mg/m² of nonradiolabeled anti-CD45 monoclonal antibody AHN-12 results in normal biodistribution, normal-organ estimated radiation-absorbed dose of less than 20 Gy, and estimated radiation-absorbed dose of no more than 13 Gy to the red marrow.

Secondary

To determine the maximum tolerated dose of yttrium Y 90 anti-CD45 monoclonal antibody AHN-12 (\^90Y-AHN-12).
To determine the human anti-mouse antibody (HAMA) response.
To define, preliminarily, the antitumor activity of \^90Y-AHN-12.

OUTLINE: This is a dose-escalation study of yttrium Y 90 anti-CD45 monoclonal antibody AHN-12 (\^90Y-AHN-12).

Biodistribution: Patients receive nonradiolabeled monoclonal antibody AHN-12 IV and an imaging dose of indium Y 111 monoclonal antibody AHN-12 (\^111In-AHN-12) IV over 10 minutes on day 0. Patients undergo whole-body gamma-camera imaging immediately following infusion, at 4-6 hours, and on days 1, 3, 4, and 7. Blood samples are collected prior to each imaging for dosimetry calculations and pharmacokinetics.

Patients also undergo bone marrow biopsy 16-24 hours after infusion for dosimetry calculations. Patients with the expected biodistribution of \^111In-AHN-12, an estimated radiation-absorbed dose to the normal organ of \< 20 Gy, an estimated radiation-absorbed dose to the red marrow of ≤ 13 Gy, and a negative human anti-mouse antibody at day 7 proceed to the therapy portion.

Treatment: Patients receive nonradiolabeled anti-CD45 monoclonal antibody AHN-12 IV over 60 minutes and escalating therapy doses of yttrium Y 90 anti-CD45 monoclonal antibody AHN-12 (\^90Y-AHN-12) IV over 10 minutes on day 7 or 8.

After completion of study treatment, patients are followed periodically for 1 year.

Conditions studied

Leukemia
Myelodysplastic Syndromes

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Keywords

recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
secondary acute myeloid leukemia
previously treated myelodysplastic syndromes
blastic phase chronic myelogenous leukemia
relapsing chronic myelogenous leukemia
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 4 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Masonic Cancer Center, University of Minnesota is the lead sponsor of 284 studies on the registry; 34 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Histologically confirmed CD45+ diseases:
- Acute lymphoblastic leukemia or acute myeloid leukemia (AML), meeting any of the following criteria:
  - Primary refractory disease
  - Relapsed disease, defined as persistent disease following a minimum of 2 different standard chemotherapy induction attempts at time of diagnosis or at relapse
- Acute myelogenous leukemia (AML), primary refractory or relapsed disease - defined as persistent disease after a minimum of two different standard chemotherapy induction attempts at time of diagnosis or relapse
- Advanced myelodysplastic syndrome (MDS) defined as > or = 15% bone marrow blasts following a minimum of one standard chemotherapy induction attempt
- AML arising from preexisting MDS, refractory - defined as persistent disease following a minimum of one standard chemotherapy induction attempt
- Chronic myelogenous leukemia (CML) following blast crisis (> or = 15% marrow blasts following a minimum of one standard chemotherapy induction attempt
Peripheral leukemic blasts (by morphology) must be \< 5,000/μL (hydroxyurea to control peripheral blast count allowed)
Must have source of allogeneic stem cells (sibling, unrelated cord[s], or donor) identified prior to initiation of protocol therapy
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 or Karnofsky PS 60-100%
Life expectancy > 12 weeks
Total bilirubin ≤ 2.5 times upper limit of normal (ULN)
aspartate aminotransferase (AST) and Alanine transaminase (ALT) ≤ 2.5 times upper limit of normal (ULN)
Creatinine ≤ 1.3 mg/dL OR creatinine clearance ≥ 60 mL/min
Left ventricular ejection fraction (LVEF) ≥ 45% by Multi Gated Acquisition Scan (MUGA) or echocardiogram (ECHO)
Carbon Monoxide Diffusing Capacity (DLCO) (corrected) ≥ 50% of predicted
Human anti-mouse antibody (HAMA) must be negative
Not pregnant or nursing
Fertile patients must use effective contraception
Human immunodeficiency virus (HIV) negative
Recovered from all prior therapy
At least 7 days since prior biologic agents

Exclusion criteria

Exclusion Criteria:

Bone marrow cellularity \< 15%
Known brain metastases or active central nervous system (CNS) disease
History of allergic reactions attributed to compounds of similar chemical or biologic composition to \^90Y-AHN-12 or other agents used in study
Uncontrolled illness, including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic or congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situations that would limit compliance with study requirements
Other concurrent investigational agents
Prior allogeneic transplantation
Less than 60 days since prior autologous transplantation with relapsed disease

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 4 participants (actual)

Study arms

Experimental
AHN-12
2.0, 5.0, 7.5, 10.0 or 12.5 mCi/m\^2 of \^90Y-AHN-12 at Day 7/8
Biological: anti-CD45 monoclonal antibody AHN-12 · Radiation: yttrium Y 90 anti-CD45 monoclonal antibody AHN-12

Interventions

Biologicalanti-CD45 monoclonal antibody AHN-12
150 mg/m\^2 cold antibody at Day 0
Also known as: ^111In-AHN-12
Radiationyttrium Y 90 anti-CD45 monoclonal antibody AHN-12
Dose per scheduled level; 2.5-12.5 mCi/m\^2
Also known as: ^90Y-AHN-12

What researchers measure

Primary outcomes

Biodistribution of nonradiolabeled anti-CD45 monoclonal antibody AHN-12
Time frame: Within 1 hour, 4-6 hours, Days 1, 3, 4 and 7 post infusion

Secondary outcomes

Maximum tolerated dose of yttrium Y 90 anti-CD45 monoclonal antibody AHN-12
Time frame: Week 8
Presence of human antibody to murine antibody
Time frame: at baseline and at 28 days, 90 days, and 6 months after completion of study treatment
Dose-limiting toxicity and response
Time frame: at days 28 and 90 after completion of study treatment

Study locations

1 site

Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota 55455, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00618696
Lead sponsor: Masonic Cancer Center, University of Minnesota
First posted: Feb 20, 2008
Start date: Jul 2005
Primary completion: Dec 2007
Completion: Dec 2007
Last update: Nov 29, 2017

Study contacts

Linda J. Burns, MD

principal investigator · Masonic Cancer Center, University of Minnesota

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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