Acute Myelogenous LeukemiaPhase 1NCT01207076
AHN-12 Biodistribution in Advanced Leukemia
A Phase 1 study testing 90Y-AHN-12 in people with Acute Myelogenous Leukemia and Myelodysplastic Syndrome, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
This study is a single institution phase I study for the treatment of patients with relapsed or refractory leukemia aged 12 years and older using 90Y-AHN-12. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acute Myelogenous Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia
- What is being tested?
- 90Y-AHN-12
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jul 2014
- 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
- Patients must have one of the following histologically confirmed CD45+ diseases. If possible, AHN-12 positivity will be confirmed by flow cytometry on a recent bone marrow or a peripheral blood sample, if circulating blasts are present.
- Acute myelogenous leukemia (AML), primary refractory or relapsed disease
- Refractory myelodysplastic syndrome (MDS)
- AML arising from pre-existing MDS, refractory
- Acute lymphoblastic leukemia (ALL), primary refractory or relapsed disease
- Chronic myelogenous leukemia (CML) following blast crisis
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- Age ≥ 12 years
- Karnofsky Performance Status ≥ 60% (16 years and older) or Lansky Play Score ≥ 60 (<16 years)
- Life expectancy of > 12 weeks in the opinion of the enrolling medical provider
- Patients must have adequate organ function
- Human anti-mouse antibody (HAMA) must be negative (perform on all patients regardless of prior therapies).
- Consent to adequate contraception. The effects of 90Y-AHN-12 on the developing fetus are unknown.
- Source of allogeneic stem cells must have been identified in event of severe myelosuppression
- Able to give written consent.
- Both men and women of all ethnic groups are eligible for this trial.
Who cannot join
- Ongoing grade 2 or greater non-hematologic toxicity due to previously administered therapies
- < 8 days from completion of therapy with any biologic agent
- Receiving any investigational agents
- Active central nervous system (CNS) leukemia are excluded from this clinical trial
- 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, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the enrolling medical provider.
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- Pregnant and breastfeeding women are excluded from this study because 90Y-AHN-12, being radioactive, as well as high dose chemotherapy and total body irradiation (TBI) have the potential for teratogenic or abortifacient effects.
- Human immunodeficiency virus (HIV) positive patients:
- < 60 days since an autologous transplant
- Bone marrow cellularity <5% (because of concern of myelosuppression)
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Phase I Open Label, Single Arm, Dose Escalation Trial to Evaluate the Biodistribution and Safety of AHN-12 In Patients With Advanced Leukemia HM2010-05
This study is a single institution phase I study for the treatment of patients with relapsed or refractory leukemia aged 12 years and older using 90Y-AHN-12.
Read the detailed description
A dose escalation schema will be used with the initial patient receiving the current lowest dose of nonradiolabeled AHN-12 (from 0.20 mg/kg to 1.0 mg/kg). If a favorable biodistribution is not achieved and the patient remains negative for HAMA, the infusion may be repeated up to two more times (with a one level increase in nonradiolabeled AHN-12 each time) in an attempt of achieving favorable biodistribution.
In order to achieve the primary objective of identifying the optimal nonradiolabeled dose of AHN-12 antibody for all patients, if the first patient at the current antibody dose does not achieve favorable biodistribution, the next patient(s) will be treated at the next higher dose level.
Patients achieving favorable biodistribution and remaining negative for HAMA will be eligible for the therapeutic component of this trial. Those not meeting these requirements will be taken off study and followed.
- Conditions
- Acute Myelogenous Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia
- Being tested
- 90Y-AHN-12
- Keywords
- CD45+ disease
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
90Y-AHN-12Biological
The intervention consists of two parts.
- The dose of cold AHN-12 to achieve favorable biodistribution through imaging using 111In-AHN-12.
- Dose escalation of nonradiolabeled AHN-12: Dose level= -1 0.20 mg/kg, Dose level=1 0.40 mg/kg, Dose level=2 0.80 mg/kg, Dose level=3 1.20 mg/kg, Dose level=4 1.60 mg/kg, Dose level=5 2.00 mg/kg
- Phase I therapeutic dosing of cold AHN-12 at dose established plus 90Y-AHN-12.
- the starting 90Y-AHN-12 dose level will be 4 Gy with the dose escalated in increments of 4 Gy to a maximum of 20 Gy.
| Study group | Role | What they receive |
|---|---|---|
| receiving AHN-12 and 90Y-AHN-12 | Experimental | Patients receiving nonradiolabeled cold AHN-12 (.20 mg/kg to 1.0 mg/kg) of at least one dose and up to a total of 3 dosimetry infusions (intervals no sooner than 8 days and up to 21 days). Receives: Biological: 90Y-AHN-12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal Dose of AHN-12 Non-radiolabeled Antibody
doses of nonradiolabeled antibody are specified: 0.20, 0.40, 0.60, 0.80 and 1.00 mg/kg.
Measured: Day 2
Secondary outcomes (3)
Maximum Tolerated Dose (MTD) of 90Y-AHN-12
•Determine the MTD of 90Y-AHN-12 for patients with a favorable biodistribution and a negative human anti-mouse antibody (HAMA). Doses of radiolabeled antibody are specified starting dose level with dose increment of 2 gray (Gy) to maximum of 22 Gy.
Measured: Within 14 days of achieving favorable biodistribution
Human Anti-Mouse Antibody (HAMA) Response
Event is whether or not the patient develops a HAMA response.
Measured: 30 and 90 Days Post Therapy, Then Every 6 Months If Positive
Anti-tumor Activity of 90Y-AHN-12
Event is response to therapy: complete remission, partial remission, refractory or relapsed disease.
Measured: 30 and 90 Days Post Therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startDec 2013
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myelogenous LeukemiaStudies of the same condition, open and under way.
- 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda Burns, M.D., Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207076
- Sponsor's protocol ID
- 2010LS030
- Status last verified
- Dec 2017
- First submitted
- 21 Sep 2010
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Open Label, Single Arm, Dose Escalation Trial to Evaluate the Biodistribution and Safety of AHN-12 In Patients With Advanced Leukemia HM2010-05
- ClinicalTrials.gov ID
- NCT01207076
- Acronym / sponsor ID
- 2010LS030
- Conditions
- Acute Myelogenous Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia
- Keywords
- CD45+ disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 22 Sep 2010 (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.
This study is a single institution phase I study for the treatment of patients with relapsed or refractory leukemia aged 12 years and older using 90Y-AHN-12.
Detailed description
A dose escalation schema will be used with the initial patient receiving the current lowest dose of nonradiolabeled AHN-12 (from 0.20 mg/kg to 1.0 mg/kg). If a favorable biodistribution is not achieved and the patient remains negative for HAMA, the infusion may be repeated up to two more times (with a one level increase in nonradiolabeled AHN-12 each time) in an attempt of achieving favorable biodistribution.
In order to achieve the primary objective of identifying the optimal nonradiolabeled dose of AHN-12 antibody for all patients, if the first patient at the current antibody dose does not achieve favorable biodistribution, the next patient(s) will be treated at the next higher dose level.
Patients achieving favorable biodistribution and remaining negative for HAMA will be eligible for the therapeutic component of this trial. Those not meeting these requirements will be taken off study and followed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| receiving AHN-12 and 90Y-AHN-12 | Experimental | Biological: 90Y-AHN-12Patients receiving nonradiolabeled cold AHN-12 (.20 mg/kg to 1.0 mg/kg) of at least one dose and up to a total of 3 dosimetry infusions (intervals no sooner than 8 days and up to 21 days). |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have one of the following histologically confirmed CD45+ diseases. If possible, AHN-12 positivity will be confirmed by flow cytometry on a recent bone marrow or a peripheral blood sample, if circulating blasts are present.
- Age ≥ 12 years
- Karnofsky Performance Status ≥ 60% (16 years and older) or Lansky Play Score ≥ 60 (<16 years)
- Life expectancy of > 12 weeks in the opinion of the enrolling medical provider
- Patients must have adequate organ function
Key exclusion criteria (10 listed)
- Ongoing grade 2 or greater non-hematologic toxicity due to previously administered therapies
- < 8 days from completion of therapy with any biologic agent
- Receiving any investigational agents
- Active central nervous system (CNS) leukemia are excluded from this clinical trial
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 90Y-AHN-12 or other agents used in study.
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 |
|---|---|---|
| 90Y-AHN-12The intervention consists of two parts. 1. The dose of cold AHN-12 to achieve favorable biodistribution through imaging using 111In-AHN-12. * Dose escalation of nonradiolabeled AHN-12: Dose level= -1 0.20 mg/kg, Dose level=1 0.40 mg/kg, Dose level=2 0.80 mg/kg, Dose level=3 1.20 mg/kg, Dose level=4 1.60 mg/kg, Dose level=5 2.00 mg/kg 2. Phase I therapeutic dosing of cold AHN-12 at dose established plus 90Y-AHN-12. * the starting 90Y-AHN-12 dose level will be 4 Gy with the dose escalated in increments of 4 Gy to a maximum of 20 Gy. | Biological | receiving AHN-12 and 90Y-AHN-12 |
Primary outcome
Optimal Dose of AHN-12 Non-radiolabeled Antibody
Time frame: Day 2
doses of nonradiolabeled antibody are specified: 0.20, 0.40, 0.60, 0.80 and 1.00 mg/kg.
3 secondary outcomes
Maximum Tolerated Dose (MTD) of 90Y-AHN-12
Time frame: Within 14 days of achieving favorable biodistribution
Human Anti-Mouse Antibody (HAMA) Response
Time frame: 30 and 90 Days Post Therapy, Then Every 6 Months If Positive
Anti-tumor Activity of 90Y-AHN-12
Time frame: 30 and 90 Days Post Therapy
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 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.
Linda Burns, M.D. 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 90Y-AHN-12 in people with Acute Myelogenous Leukemia and Myelodysplastic Syndrome, 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 15 inclusion and 10 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 5 Dec 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: 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?
Optimal Dose of AHN-12 Non-radiolabeled Antibody (time frame: Day 2). 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 5 Dec 2017.