Clinical trial · Interventional
Study of mAb 216 With Chemotherapy for Treatment of Pediatric Relapsed or Refractory B-progenitor Acute Lymphoblastic Leukemia
A Phase I Study of mAb 216 With Chemotherapy for the Treatment of Pediatric Patients With Relapsed or Refractory B-progenitor Acute Lymphoblastic Leukemia
NCT00313053CI-TRIAL-00022468terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase I trial in patients with relapsed or refractory leukemia of a human monoclonal antibody that kills B cell acute lymphoblastic leukemia. The trial will study the safety, pharmacokinetics, and anti-tumor activity of the antibody given as a single agent and with vincristine.
Conditions
Conditions (3)
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 Lymphoid Leukemia (ALL) | Acute Lymphoblastic Leukemia | ALIAS | 0.85 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Leukemia, Lymphocytic, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Human mAb 216 | Drug | — | UNRESOLVED |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Human mAb 216
- interventionNames
- Drug: Human mAb 216
- Drug: Vincristine
Primary outcomes (2)
- measure
- Maximum tolerable dose without toxicity
- measure
- Safety
Secondary outcomes (1)
- measure
- Decrease in leukemic blasts
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Months
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:- Patients must be \> than 12 months at the time of study entry. * Patients must have had histologic verification of B-lineage ALL with bone marrow relapse or refractory disease that is unresponsive to traditional chemotherapy. * For patients WITHOUT prior allogeneic bone marrow transplant (BMT): * Second or subsequent bone marrow relapse * Primary refractory marrow disease * M3 marrow (\> 25% blasts) * For patients WITH prior allogeneic BMT: * First or subsequent bone marrow relapse post-BMT * M3 marrow or M2 (\> 5% and \< 25% blasts) if cytogenetic or variable number tandem repeat (VNTR) confirmation * Confirmation of antibody reactivity * Patient's leukemic blasts (peripheral blood or marrow) must be documented to bind mAb 216 in vitro (Teng lab). * Patient's red blood cell (RBC) documented to NOT express fetal "i" antigen and RBC shown to NOT bind mAb 216 in vitro (Teng lab) * Patient must not be eligible for therapies of higher priority * Performance level Karnofsky 50% for patients \> 10 years of age and Lansky \>= 50 for patients \<= 10 years of age. * Life expectancy must be at least 8 weeks. * Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study: * Myelosuppressive chemotherapy: must not have been received within 2 weeks of entry onto this study. * Biologic: at least 7 days since the completion of therapy with a biologic agent. * No hematologic criteria for white blood cell (WBC), hemoglobin (Hgb), or platelets * Patients with thrombocytopenia should be responsive to platelet transfusions and must not have uncontrolled bleeding. * Adequate renal function defined as: a serum creatinine that is less than or equal to 1.5 x normal for age * Adequate liver function defined as: total bilirubin \<= 1.5 x upper limit of normal (ULN) for age, and SGPT (ALT) \<= 5 x upper limit of normal (ULN) for age * Adequate cardiac function defined as: shortening fraction of \>= 27% by echocardiogram, or ejection fraction of \>= 50% by gated radionuclide study. * All patients and/or their parents or legal guardians must sign a written informed consent/assent. * All Institutional Review Board (IRB) and Food and Drug Administration (FDA) requirements for human studies must be met. Exclusion Criteria:- Central nervous system (CNS) 3 or refractory CNS leukemia * Isolated extramedullary relapse * Uncontrolled infection * Lack of mAb 216 binding to patient's leukemic blasts in vitro * Binding of mAb 216 to the"i" antigen on patient's erythrocytes * Prior treatment with rituximab
References
Publications (0)
Data not yet available
No reference posted for this study.