Status:
TERMINATED
Study of mAb 216 With Chemotherapy for Treatment of Pediatric Relapsed or Refractory B-progenitor Acute Lymphoblastic Leukemia
Lead Sponsor:
Clare Twist
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Leukemia, Lymphocytic, Acute
Leukemia
Eligibility:
All Genders
12-18 years
Phase:
PHASE1
Brief Summary
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, pharmacokinetic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00313053
Start Date
September 1 2004
End Date
July 1 2008
Last Update
June 3 2016
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305