NCT00313053

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

June 3, 2016

Status Verified

November 1, 2012

Enrollment Period

3.6 years

First QC Date

April 7, 2006

Last Update Submit

June 1, 2016

Conditions

Leukemia, Lymphocytic, AcuteLeukemiaAcute Lymphoid Leukemia (ALL)

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerable dose without toxicity

  • Safety

Secondary Outcomes (1)

  • Decrease in leukemic blasts

Study Arms (1)

Human mAb 216

EXPERIMENTAL
Drug: Human mAb 216Drug: Vincristine

Interventions

Human mAb 216DRUG

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

Human mAb 216
VincristineDRUG

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

Human mAb 216

Eligibility Criteria

Age12 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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:
  • +8 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaLeukemia

Interventions

Vincristine

Condition Hierarchy (Ancestors)

Leukemia, LymphoidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Vinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Clare J. Twist M.D.

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

April 7, 2006

First Posted

April 11, 2006

Study Start

September 1, 2004

Primary Completion

April 1, 2008

Study Completion

July 1, 2008

Last Updated

June 3, 2016

Record last verified: 2012-11

Locations

US(1)