NCT00017472

Brief Summary

Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have chronic lymphocytic leukemia, lymphocytic lymphoma, acute lymphoblastic leukemia, or acute myeloid leukemia.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P50-P75 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

Study Start

First participant enrolled

April 1, 2001

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2001

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

5 years

First QC Date

June 6, 2001

Last Update Submit

June 3, 2013

Conditions

Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueNodal Marginal Zone B-cell LymphomaNoncontiguous Stage II Marginal Zone LymphomaNoncontiguous Stage II Small Lymphocytic LymphomaRecurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Acute Myeloid LeukemiaRecurrent Marginal Zone LymphomaRecurrent Small Lymphocytic LymphomaRefractory Chronic Lymphocytic LeukemiaSplenic Marginal Zone LymphomaStage III Marginal Zone LymphomaStage III Small Lymphocytic LymphomaStage IV Marginal Zone LymphomaStage IV Small Lymphocytic Lymphoma

Outcome Measures

Primary Outcomes (1)

  • MTD defined as the dose level below which two or more of six patients experience a DLT assessed using NCI CTC version 2.0

    Up to 30 days

Secondary Outcomes (4)

  • Evaluation of the degree of apoptosis induced by ex vivo incubation of human CLL cells with Hu1D10

    Up to 1 year

  • Cytokine release

    Up to 1 year

  • Caspase activation

    Up to 1 year

  • Signaling and expression of apoptosis protein

    Up to 1 year

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive apolizumab IV over at least 2 hours on days 1, 2, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with a complete or partial response who relapse after 2 months may receive an additional course of therapy provided they still express the 1D10 antigen.

Biological: apolizumabOther: laboratory biomarker analysisOther: pharmacological study

Interventions

apolizumabBIOLOGICAL

Given IV

Also known as: 1D1O Anti-lymphoma Antibody, MOAB 1D10, MoAb Hu1D10, Monoclonal antibody 1D10, Monoclonal Antibody Hu1D10
Arm I
laboratory biomarker analysisOTHER

Correlative studies

Arm I
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Arm I

Eligibility Criteria

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

You may qualify if:

  • One of the following diagnoses:
  • Histologically confirmed chronic lymphocytic leukemia (CLL) or non-contiguous stage II or stage III-IV small lymphocytic lymphoma (SLL)
  • Previously treated with at least 1 form of chemotherapy or immunotherapy
  • Histologically confirmed acute lymphoblastic leukemia (enrolled after the maximum tolerated dose (MTD) is determined)
  • Must have failed 1 prior therapy
  • Ineligible for allogeneic stem cell transplantation
  • Histologically confirmed acute myeloid leukemia (enrolled after the MTD is determined)
  • Primary refractory or relapsed (within the past year) disease
  • Ineligible for potential curative therapy
  • Express Hu1D10 antigen
  • Greater than 2 times the mean fluorescence intensity of the control by flow cytometry (blood or bone marrow cells) OR
  • Positive by immunohistochemical staining (lymph node)
  • Presenting with one of the following indications for treatment unless early bone marrow transplantation is planned (CLL or SLL patients only):
  • Disease-related progressive symptoms
  • Progressively worsening anemia or thrombocytopenia
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal ZonePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

apolizumab

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidLeukemiaHematologic DiseasesLeukemia, MyeloidLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • John Byrd

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2001

First Posted

January 27, 2003

Study Start

April 1, 2001

Primary Completion

April 1, 2006

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations

US(1)