LeukemiaPhase 1NCT00643240
Yttrium Y 90 Anti-CD19 Antibody BU-12 in Patients With Advanced Relapsed or Refractory Acute Lymphoblastic Leukemia or Chronic Lymphocytic Leukemia
A Phase 1 study testing yttrium Y 90 anti-CD19 monoclonal antibody BU12 and 111In-BU-12 in people with Leukemia, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- yttrium Y 90 anti-CD19 monoclonal antibody BU12 and 111In-BU-12
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Apr 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Leukemia
- Being tested
- yttrium Y 90 anti-CD19 monoclonal antibody BU12, 111In-BU-12
- Keywords
- recurrent adult acute lymphoblastic leukemia, recurrent childhood acute lymphoblastic leukemia, refractory chronic lymphocytic leukemia
- Medical subject headings
- Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yttrium Y 90 anti-CD19 monoclonal antibody BU12Radiation
Also called 90Y-BU-12
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.
111In-BU-12Radiation
Also called indium-111 BU-12
Patients receive indium-111 BU-12 IV over 60 minutes on day 0
| Study group | Role | What they receive |
|---|---|---|
| 111 In-BU-12 | Experimental | 111In-BU-12 is the 111Indium-labeled murine monoclonal antibody used for imaging and dosimetry. Receives: Radiation: yttrium Y 90 anti-CD19 monoclonal antibody BU12; Radiation: 111In-BU-12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Beginning Day 1 of treatment
Presence or absence of a human antibody to murine antibody
Presence or absence of a human antibody to murine antibody at baseline, 28 and 60 days post therapy, and at 6 months post therapy
Measured: baseline, 28 and 60 days post therapy, and at 6 months post therapy
Number of Patients by Clinical Response
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.
Measured: day 28 and day 60
Time to Clinical Response
Time-to-event will be measured from date of therapy dose.
Measured: Day 28, 60, 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: Due to slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brenda Weigel, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643240
- Sponsor's protocol ID
- 2006LS057
- Other IDs
- MT2006-09, UMN-0611M96887
- Status last verified
- Nov 2017
- First submitted
- 25 Mar 2008
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Open Label, Single Arm Escalation Trial to Evaluate the Biodistribution and Safety of BU-12 in Patients With Advanced Leukemia
- ClinicalTrials.gov ID
- NCT00643240
- Acronym / sponsor ID
- 2006LS057
- Conditions
- Leukemia
- Keywords
- recurrent adult acute lymphoblastic leukemia, recurrent childhood acute lymphoblastic leukemia, refractory chronic lymphocytic leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to slow accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 26 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 111 In-BU-12 | Experimental | Radiation: yttrium Y 90 anti-CD19 monoclonal antibody BU12, Radiation: 111In-BU-12111In-BU-12 is the 111Indium-labeled murine monoclonal antibody used for imaging and dosimetry. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically confirmed CD19-positive (> 25% by flow cytometry evaluation of bone marrow blasts) disease of 1 of the following types:
- 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%
Key exclusion criteria (14 listed)
- 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:
- HIV-positive
- Active graft-vs-host disease
- Less than 4 weeks since prior agents and recovered
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| yttrium Y 90 anti-CD19 monoclonal antibody BU12Also: 90Y-BU-12Patients 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. | Radiation | 111 In-BU-12 |
| 111In-BU-12Also: indium-111 BU-12Patients receive indium-111 BU-12 IV over 60 minutes on day 0 | Radiation | 111 In-BU-12 |
Primary outcome
Biodistribution of indium-111 BU-12
Time frame: 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.
4 secondary outcomes
Maximum tolerated dose of yttrium Y 90 anti-CD19 antibody BU-12
Time frame: Beginning Day 1 of treatment
Presence or absence of a human antibody to murine antibody
Time frame: baseline, 28 and 60 days post therapy, and at 6 months post therapy
Number of Patients by Clinical Response
Time frame: day 28 and day 60
Time to Clinical Response
Time frame: Day 28, 60, 6 Months
Results and safety
The study was stopped early (reason given: Due to slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brenda Weigel, MD principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing yttrium Y 90 anti-CD19 monoclonal antibody BU12 and 111In-BU-12 in people with Leukemia, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodistribution of indium-111 BU-12 (time frame: Immediately post infusion, 4-6 hours after infusion and Days 1, 3, 4 and 7 after infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2017.