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

NCT ID: NCT00313053

Last Updated: 2016-06-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2008-07-31

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.

Conditions

Leukemia, Lymphocytic, Acute; Leukemia; Acute Lymphoid Leukemia (ALL)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Human mAb 216

Group Type: EXPERIMENTAL

Human mAb 216

Intervention Type: DRUG

Two treatment courses of mAb infusion will be given, with the same dose of antibody administered on Day 0 and on Day 7.

Vincristine

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Vincristine

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Clare Twist

OTHER

Sponsor Role: lead

Responsible Party

Clare Twist

Associate Professor of Pediatrics

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Clare J. Twist M.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

95343

Identifier Type: -

Identifier Source: secondary_id

CA85199-01

Identifier Type: -

Identifier Source: secondary_id

NCT00313053

Identifier Type: -

Identifier Source: secondary_id

PEDSMAB216

Identifier Type: -

Identifier Source: secondary_id

13822

Identifier Type: OTHER

Identifier Source: secondary_id

PEDSMAB216

Identifier Type: -

Identifier Source: org_study_id