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About
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.
Enrollment
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Volunteers
Inclusion and exclusion criteria
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):
For patients WITH prior allogeneic BMT:
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:
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
Primary purpose
Allocation
Interventional model
Masking
4 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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