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A Phase I Study of mAb 216 With Chemotherapy for the Treatment of Pediatric Patients With Relapsed or Refractory B-progenitor Acute Lymphoblastic Leukemia

Phase 1
12 Months
18 Years
Not Enrolling
Leukemia, Lymphocytic, Acute, Leukemia, Acute Lymphoid Leukemia (ALL)

Thank you

Trial Information

A Phase I Study of mAb 216 With Chemotherapy for the Treatment of Pediatric Patients With Relapsed or Refractory B-progenitor Acute Lymphoblastic Leukemia

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerable dose without toxicity

Outcome Time Frame:

not known

Safety Issue:


Principal Investigator

Clare J. Twist M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Food and Drug Administration

Study ID:




Start Date:

September 2004

Completion Date:

July 2008

Related Keywords:

  • Leukemia, Lymphocytic, Acute
  • Leukemia
  • Acute Lymphoid Leukemia (ALL)
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma



Stanford University School of Medicine Stanford, California  94305-5317