NCT00313079

Brief Summary

A phase I trial in patients with relapsed or refractory leukemia of a human monoclonal antibody that kills B cell acute lymphoblastic leukemia. Trial will study safety, pharmacokinetics, and anti tumor activity of the antibody given as a single agent and with vincristine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

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
20 days until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

July 3, 2012

Status Verified

June 1, 2012

Enrollment Period

2.8 years

First QC Date

April 7, 2006

Last Update Submit

June 29, 2012

Conditions

Leukemia, LymphocyticLeukemiaAcute Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

  • In this phase I study the endpoint is the determination of the maximum tolerable dose without toxicity.

Secondary Outcomes (1)

  • A decrease in leukemic blasts. The study will be terminated if unacceptable doseSecondary endpoints are a decrease in leukemic blasts. The study will be terminated if unacceptable dose limiting toxicity is found. This is a phase I trial to study safety.

Interventions

MAb 216DRUG

Dosage: 1.25mg/kg intravenous with dose escalation

Also known as: Monoclonal Antibody 216
VincristineDRUG

Dosage: 1.5mg/m2 intravenous weekly X 4

Also known as: Oncovin, leurocristine, VCR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age Patients must be \>= 18 years old at the time of study entry.
  • Diagnosis
  • Histologic Verification 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 BMT:
  • Second or subsequent bone marrow relapse
  • Primary refractory marrow disease
  • M3 marrow (\>25% blasts) or \>25% leukemic blasts in peripheral blood
  • 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 VNTR confirmation
  • Confirmation of antibody reactivity 3.1.3.1 Patient's leukemic blasts (peripheral blood or marrow) must be documented to bind mAb 216 in vitro (Teng lab) 3.1.3.2 Patient's 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 (See Appendix I) Karnofsky \>= 50%
  • Life Expectancy Must be at least 8 weeks.
  • Prior Therapy Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
  • +15 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

  • Liedtke M, Twist CJ, Medeiros BC, Gotlib JR, Berube C, Bieber MM, Bhat NM, Teng NN, Coutre SE. Phase I trial of a novel human monoclonal antibody mAb216 in patients with relapsed or refractory B-cell acute lymphoblastic leukemia. Haematologica. 2012 Jan;97(1):30-7. doi: 10.3324/haematol.2011.045997. Epub 2011 Oct 11.

    PMID: 21993685RESULT

MeSH Terms

Conditions

Leukemia, LymphoidLeukemiaPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Vincristine

Condition Hierarchy (Ancestors)

Neoplasms 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

  • Nelson N Teng

    Stanford University

    SUB INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 7, 2006

First Posted

April 11, 2006

Study Start

May 1, 2006

Primary Completion

February 1, 2009

Study Completion

July 1, 2009

Last Updated

July 3, 2012

Record last verified: 2012-06

Locations

US(1)