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

NCT00643240 | Terminated Phase 1 DMC

• 3 other identifiers: 2006LS057MT2006-09UMN-0611M96887
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leukemia

Keywords

recurrent adult acute lymphoblastic leukemia; recurrent childhood acute lymphoblastic leukemia; refractory chronic lymphocytic leukemia

Outcome Measures

Primary Outcomes (1)

• Biodistribution of indium-111 BU-12

  Perform a whole body scan acquiring both anterior and posterior images at a speed of 10 cm/min (20 minute scan) using a medium energy collimator, a 256 x 1024 computer acquisition matrix and acquisition photo peak settings of 172 and 247 keV with 15% windows.

  Immediately post infusion, 4-6 hours after infusion and Days 1, 3, 4 and 7 after infusion

Secondary Outcomes (4)

• Maximum tolerated dose of yttrium Y 90 anti-CD19 antibody BU-12

  Beginning Day 1 of treatment

• Presence or absence of a human antibody to murine antibody

  baseline, 28 and 60 days post therapy, and at 6 months post therapy

• Number of Patients by Clinical Response

  day 28 and day 60

• Time to Clinical Response

  Day 28, 60, 6 Months

Study Arms (1)

111 In-BU-12

EXPERIMENTAL

111In-BU-12 is the 111Indium-labeled murine monoclonal antibody used for imaging and dosimetry.

Radiation: yttrium Y 90 anti-CD19 monoclonal antibody BU12; Radiation: 111In-BU-12

Interventions

yttrium Y 90 anti-CD19 monoclonal antibody BU12 RADIATION

Patients in whom the biodistribution is as expected (unaltered) AND a HAMA response does not develop will receive a single dose of 90Y-BU-12 in a dose escalated manner to establish the maximum tolerated dose (MTD) of 90Y-BU-12 over 60 minutes on Day 0. A single course of BU-12 includes the imaging dose of 111In-BU-12 followed 7-8 days later by the therapy dose of 90YBU- 12.

Also known as: 90Y-BU-12

111 In-BU-12

111In-BU-12 RADIATION

Patients receive indium-111 BU-12 IV over 60 minutes on day 0

Also known as: indium-111 BU-12

111 In-BU-12

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

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; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Brenda Weigel, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2008
• First Posted: March 26, 2008
• Study Start: January 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: November 29, 2017

Record last verified: 2017-11

Locations

US (1)