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Study of mAb 216 With Chemotherapy for Treatment of Pediatric Relapsed or Refractory B-progenitor Acute Lymphoblastic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00313053
Recruitment Status : Terminated
First Posted : April 11, 2006
Last Update Posted : June 3, 2016
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Clare Twist, Stanford University

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, pharmacokinetics, and anti-tumor activity of the antibody given as a single agent and with vincristine.

Condition or disease Intervention/treatment Phase
Leukemia, Lymphocytic, Acute Leukemia Acute Lymphoid Leukemia (ALL) Drug: Human mAb 216 Drug: Vincristine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of mAb 216 With Chemotherapy for the Treatment of Pediatric Patients With Relapsed or Refractory B-progenitor Acute Lymphoblastic Leukemia
Study Start Date : September 2004
Actual Primary Completion Date : April 2008
Actual Study Completion Date : July 2008

Arm Intervention/treatment
Experimental: Human mAb 216 Drug: Human mAb 216
Two treatment courses of mAb infusion will be given, with the same dose of antibody administered on Day 0 and on Day 7.

Drug: Vincristine
Vincristine 1.5 mg/m2/dose (max dose = 2 mg) IVP on weekly x 4 doses (Days 7, 14, 21, 28)

Primary Outcome Measures :
  1. Maximum tolerable dose without toxicity
  2. Safety

Secondary Outcome Measures :
  1. Decrease in leukemic blasts

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00313053

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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Clare Twist
National Institutes of Health (NIH)
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Principal Investigator: Clare J. Twist M.D. Stanford University
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Responsible Party: Clare Twist, Associate Professor of Pediatrics, Stanford University Identifier: NCT00313053    
Other Study ID Numbers: PEDSMAB216
13822 ( Other Identifier: Stanford IRB )
First Posted: April 11, 2006    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: November 2012
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action