Clinical trial · Interventional
AHN-12 Biodistribution in Advanced Leukemia
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
NCT01207076CI-TRIAL-00030656terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 90Y-AHN-12 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- receiving AHN-12 and 90Y-AHN-12
- description
- 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).
- interventionNames
- Biological: 90Y-AHN-12
Primary outcomes (1)
- measure
- Optimal Dose of AHN-12 Non-radiolabeled Antibody
- timeFrame
- Day 2
- description
- doses of nonradiolabeled antibody are specified: 0.20, 0.40, 0.60, 0.80 and 1.00 mg/kg.
Secondary outcomes (3)
- measure
- Maximum Tolerated Dose (MTD) of 90Y-AHN-12
- timeFrame
- Within 14 days of achieving favorable biodistribution
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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. * 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)
References
Publications (0)
Data not yet available
No reference posted for this study.