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

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00313053
First received: April 7, 2006
Last updated: May 31, 2011
Last verified: October 2010
History of Changes
  Purpose

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 Intervention Phase
Leukemia, Lymphocytic, Acute
Leukemia
Acute Lymphoid Leukemia (ALL)
 Drug: Human mAb 216
Drug: Vincristine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Maximum tolerable dose without toxicity [ Time Frame: not known ] [ Designated as safety issue: Yes ]
  • Safety [ Time Frame: unknown ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Decrease in leukemic blasts [ Time Frame: unknown ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2004
Study Completion Date: July 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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):

    • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00313053

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
Investigators
Principal Investigator: Clare J. Twist M.D. Stanford University
  More Information

No publications provided

Responsible Party: Clare J. Twist M.D., Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00313053     History of Changes
Other Study ID Numbers: PEDSMAB216, 95343, CA85199-01, PEDSMAB216
Study First Received: April 7, 2006
Last Updated: May 31, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Vincristine
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013