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

NCT00618696 | Terminated Phase 1 DMC

• 2 other identifiers: 2005LS039UMN-MT2005-13R
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Leukemia; Myelodysplastic Syndromes

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)

Outcome Measures

Primary Outcomes (1)

• Biodistribution of nonradiolabeled anti-CD45 monoclonal antibody AHN-12

  Within 1 hour, 4-6 hours, Days 1, 3, 4 and 7 post infusion

Secondary Outcomes (3)

• Maximum tolerated dose of yttrium Y 90 anti-CD45 monoclonal antibody AHN-12

  Week 8

• Presence of human antibody to murine antibody

  at baseline and at 28 days, 90 days, and 6 months after completion of study treatment

• Dose-limiting toxicity and response

  at days 28 and 90 after completion of study treatment

Study Arms (1)

AHN-12

EXPERIMENTAL

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

anti-CD45 monoclonal antibody AHN-12 BIOLOGICAL

150 mg/m\^2 cold antibody at Day 0

Also known as: ^111In-AHN-12

AHN-12

yttrium Y 90 anti-CD45 monoclonal antibody AHN-12 RADIATION

Dose per scheduled level; 2.5-12.5 mCi/m\^2

Also known as: ^90Y-AHN-12

AHN-12

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Blast Crisis; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Myeloproliferative Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Linda J. Burns, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 20, 2008
• Study Start: July 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: November 29, 2017

Record last verified: 2017-11

Locations

US (1)