Clinical trial · Interventional
Yttrium Y 90 Anti-CD19 Antibody BU-12 in Patients With Advanced Relapsed or Refractory Acute Lymphoblastic Leukemia or Chronic Lymphocytic Leukemia
Phase I Open Label, Single Arm Escalation Trial to Evaluate the Biodistribution and Safety of BU-12 in Patients With Advanced Leukemia
NCT00643240CI-TRIAL-00030584terminatedPhase 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): Due to slow accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 111In-BU-12 | Radiation | — | UNRESOLVED |
| yttrium Y 90 anti-CD19 monoclonal antibody BU12 | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 111 In-BU-12
- description
- 111In-BU-12 is the 111Indium-labeled murine monoclonal antibody used for imaging and dosimetry.
- interventionNames
- Radiation: yttrium Y 90 anti-CD19 monoclonal antibody BU12
- Radiation: 111In-BU-12
Primary outcomes (1)
- measure
- Biodistribution of indium-111 BU-12
- timeFrame
- Immediately post infusion, 4-6 hours after infusion and Days 1, 3, 4 and 7 after infusion
- description
- 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.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.