Yttrium Y 90 Anti-CD19 Antibody BU-12 in Patients With Advanced Relapsed or Refractory Acute Lymphoblastic Leukemia or Chronic Lymphocytic Leukemia

University of Minnesota (UMN)

Status and phase

Terminated

Phase 1

Conditions

Leukemia

Treatments

Radiation: 111In-BU-12

Radiation: yttrium Y 90 anti-CD19 monoclonal antibody BU12

Study type

Interventional

Funder types

Other

Identifiers

NCT00643240

2006LS057

UMN-0611M96887 (Other Identifier)

MT2006-09 (Other Identifier)

Details and patient eligibility

About

RATIONALE: Radiolabeled monoclonal antibodies can find cancer cells and carry cancer-killing substances to them without harming normal cells. This may be effective treatment for leukemia.

PURPOSE: This phase I trial is studying the best dose of yttrium Y 90-labeled monoclonal antibody BU-12 in treating patients with advanced relapsed or refractory acute lymphoblastic leukemia or chronic lymphocytic leukemia.

Full description

OBJECTIVES:

Primary

To determine the biodistribution of indium-111 BU-12 in patients with refractory CD19+ leukemia.

Secondary

To determine the maximum tolerated dose of yttrium Y 90 anti-CD19 antibody BU-12
Determine the human anti-mouse antibody (HAMA) response.
To define, preliminarily, the antitumor activity of yttrium Y 90 anti-CD19 antibody BU-12.

OUTLINE: Patients receive yttrium Y 90 anti-CD19 antibody BU-12/indium-111 BU-12 IV over 60 minutes on day 0 and undergo whole-body imaging on days 0, 1, 3, 4, and 7. Patients also undergo blood collection and bone marrow biopsy periodically for dosimetry calculations and pharmacokinetics.

After completion of study treatment, patients are followed periodically for 2 years.

Enrollment

1 patient

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically confirmed CD19-positive (> 25% by flow cytometry evaluation of bone marrow blasts) disease of 1 of the following types:
- Primary refractory or relapsed acute lymphoblastic leukemia (ALL) defined as persistent disease following a minimum of two different standard effective chemotherapy induction attempts at time of diagnosis or at relapse
- Chronic Lymphocytic leukemia (CLL) following blast crisis (≥15% bone marrow blasts following a minimum of one standard effective chemotherapy induction attempt)
Human anti-mouse antibody (HAMA) must be negative
Patients who have relapsed ≥ 60 days following an autologous or allogeneic transplant are eligible if all other eligibility criteria are met
No active central nervous system (CNS) disease
ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
Life expectancy > 8 weeks
Total bilirubin ≤ 2.5 times upper limit of normal (ULN)
AST and ALT ≤ 2.5 times ULN
Creatinine normal OR creatinine clearance ≥ 60 mL/min
LVEF ≥ 45% by MUGA/ECHO
Oxygen saturation on room air > 92% and no oxygen requirement
Not pregnant or nursing
Negative pregnancy test
Fertile patients mus use effective contraception

Exclusion criteria

History of allergic reactions attributed to compounds of similar chemical or biologic composition to of yttrium Y 90 anti-CD19 antibody BU-12 or other agents used in study
Uncontrolled illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situations that would limit compliance with study requirements
HIV-positive
Active graft-vs-host disease
Less than 4 weeks since prior agents and recovered
Less than 7 days since prior therapy with any biologic agent, defined as a growth factor or cytokine
Less than 3 months since prior antibody or biologic anticancer therapy (e.g., alemtuzumab or epratuzumab)
Other concurrent investigational agents
Patients with peripheral blasts > 5,000/uL may receive concurrent hydroxyurea