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

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00313053
• Other study ID #: PEDSMAB216
• Secondary ID: 95343CA85199-01P
• Status: Terminated
• Phase: Phase 1
• First received: April 7, 2006
• Last updated: June 1, 2016
• Start date: September 2004
• Est. completion date: July 2008

Study information

• Verified date: November 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 18 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Clare Twist	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerable dose without toxicity		not known	Yes
Primary	Safety		unknown	Yes
Secondary	Decrease in leukemic blasts		unknown	No