Clinical trial · Interventional
Yttrium Y 90 Anti-CD45 Monoclonal Antibody AHN-12 in Treating Patients With Advanced Leukemia
MT2005-13R - Phase I Open Label, Single Arm, Dose Escalation Trial to Evaluate the Biodistribution and Safety of AHN-12 in Patients With Advanced Leukemia
NCT00618696CI-TRIAL-00030592terminatedPhase 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): Replaced with another study
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Radioactive monoclonal antibodies, such as yttrium Y 90 monoclonal antibody, can find cancer cells and either kill them or carry cancer-killing substances to them without harming normal cells. PURPOSE: This phase I trial is studying the side effects and best dose of a yttrium Y 90 monoclonal antibody and how much radiation is taken in by the organs in the body in treating patients with advanced leukemia or other hematologic disorder.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-CD45 monoclonal antibody AHN-12 | Biological | — | UNRESOLVED |
| yttrium Y 90 anti-CD45 monoclonal antibody AHN-12 | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AHN-12
- description
- 2.0, 5.0, 7.5, 10.0 or 12.5 mCi/m\^2 of \^90Y-AHN-12 at Day 7/8
- interventionNames
- Biological: anti-CD45 monoclonal antibody AHN-12
- Radiation: yttrium Y 90 anti-CD45 monoclonal antibody AHN-12
Primary outcomes (1)
- measure
- Biodistribution of nonradiolabeled anti-CD45 monoclonal antibody AHN-12
- timeFrame
- Within 1 hour, 4-6 hours, Days 1, 3, 4 and 7 post infusion
Secondary outcomes (3)
- measure
- Maximum tolerated dose of yttrium Y 90 anti-CD45 monoclonal antibody AHN-12
- timeFrame
- Week 8
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed CD45+ diseases:
* Acute lymphoblastic leukemia or acute myeloid leukemia (AML), meeting any of the following criteria:
* Primary refractory disease
* Relapsed disease, defined as persistent disease following a minimum of 2 different standard chemotherapy induction attempts at time of diagnosis or at relapse
* Acute myelogenous leukemia (AML), primary refractory or relapsed disease - defined as persistent disease after a minimum of two different standard chemotherapy induction attempts at time of diagnosis or relapse
* Advanced myelodysplastic syndrome (MDS) defined as \> or = 15% bone marrow blasts following a minimum of one standard chemotherapy induction attempt
* AML arising from preexisting MDS, refractory - defined as persistent disease following a minimum of one standard chemotherapy induction attempt
* Chronic myelogenous leukemia (CML) following blast crisis (\> or = 15% marrow blasts following a minimum of one standard chemotherapy induction attempt
* Peripheral leukemic blasts (by morphology) must be \< 5,000/μL (hydroxyurea to control peripheral blast count allowed)
* Must have source of allogeneic stem cells (sibling, unrelated cord\[s\], or donor) identified prior to initiation of protocol therapy
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 or Karnofsky PS 60-100%
* Life expectancy \> 12 weeks
* Total bilirubin ≤ 2.5 times upper limit of normal (ULN)
* aspartate aminotransferase (AST) and Alanine transaminase (ALT) ≤ 2.5 times upper limit of normal (ULN)
* Creatinine ≤ 1.3 mg/dL OR creatinine clearance ≥ 60 mL/min
* Left ventricular ejection fraction (LVEF) ≥ 45% by Multi Gated Acquisition Scan (MUGA) or echocardiogram (ECHO)
* Carbon Monoxide Diffusing Capacity (DLCO) (corrected) ≥ 50% of predicted
* Human anti-mouse antibody (HAMA) must be negative
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Human immunodeficiency virus (HIV) negative
* Recovered from all prior therapy
* At least 7 days since prior biologic agents
Exclusion Criteria:
* Bone marrow cellularity \< 15%
* Known brain metastases or active central nervous system (CNS) disease
* 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, any of the following:
* Ongoing or active infection
* Symptomatic or congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness or social situations that would limit compliance with study requirements
* Other concurrent investigational agents
* Prior allogeneic transplantation
* Less than 60 days since prior autologous transplantation with relapsed diseaseReferences
Publications (0)
Data not yet available
No reference posted for this study.