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

27. november 2017 opdateret af: Masonic Cancer Center, University of Minnesota

Phase I Open Label, Single Arm Escalation Trial to Evaluate the Biodistribution and Safety of BU-12 in Patients With Advanced Leukemia

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • Masonic Cancer Center at University of Minnesota

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 111 In-BU-12
111In-BU-12 is the 111Indium-labeled murine monoclonal antibody used for imaging and dosimetry.
Stråling: yttrium Y 90 anti-CD19 monoclonal antibody BU12
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.
Andre navne:
  • 90Y-BU-12
Stråling: 111In-BU-12
Patients receive indium-111 BU-12 IV over 60 minutes on day 0
Andre navne:
  • indium-111 BU-12

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Biodistribution of indium-111 BU-12
Tidsramme: Immediately post infusion, 4-6 hours after infusion and Days 1, 3, 4 and 7 after infusion
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum tolerated dose of yttrium Y 90 anti-CD19 antibody BU-12
Tidsramme: Beginning Day 1 of treatment
DLT will be defined as bone marrow aplasia > 6 weeks duration from the first treatment day; specifically, failure to recover peripheral ANC > 500/μL and platelets > 20,000/μL documented by bone marrow aplasia, not malignant infiltration - Any NCI CTCAE v 3.0 grade 3 non-hematologic toxicity except for allergic reactions to radiolabeled BU-12 will be dose limiting. If the BU-12 antibody is very allergenic, then ≥ grade 3 allergic reactions will be dose limiting.
Beginning Day 1 of treatment
Presence or absence of a human antibody to murine antibody
Tidsramme: baseline, 28 and 60 days post therapy, and at 6 months post therapy
Presence or absence of a human antibody to murine antibody at baseline, 28 and 60 days post therapy, and at 6 months post therapy
baseline, 28 and 60 days post therapy, and at 6 months post therapy
Number of Patients by Clinical Response
Tidsramme: day 28 and day 60
Patients evaluable for DLT will be assessed for response at day 28 and day 60 post therapy dose (event is whether or not the patient has a Complete Remission, Partial Remission, Stable Disease, Refractory Disease, Relapsed Disease). The proportion of patients by disease status will be reported.
day 28 and day 60
Time to Clinical Response
Tidsramme: Day 28, 60, 6 Months
Time-to-event will be measured from date of therapy dose.
Day 28, 60, 6 Months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Masonic Cancer Center, University of Minnesota

Efterforskere

  • Ledende efterforsker: Brenda Weigel, MD, Masonic Cancer Center, University of Minnesota

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2008

Primær færdiggørelse (Faktiske)

1. april 2010

Studieafslutning (Faktiske)

1. april 2010

Datoer for studieregistrering

Først indsendt

25. marts 2008

Først indsendt, der opfyldte QC-kriterier

25. marts 2008

Først opslået (Skøn)

26. marts 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. november 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. november 2017

Sidst verificeret

1. november 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2006LS057
  • MT2006-09 (Anden identifikator: Blood and Marrow Transplantation Program)
  • UMN-0611M96887 (Anden identifikator: IRB, University of Minnesota)

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