NCT00546793

Brief Summary

The purpose of this study is to determine if a subcutaneous (SC) dosing schedule of veltuzumab can be established in NHL or CLL patients and to confirm the safety and efficacy of veltuzumab that was previously established when administered intravenously.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_1

Geographic Reach
1 country

5 active sites

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

October 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

August 16, 2021

Status Verified

March 1, 2013

Enrollment Period

5.2 years

First QC Date

October 17, 2007

Last Update Submit

August 12, 2021

Conditions

NHLLymphoma, Non-HodgkinLymphoma, B-CellLymphoma, FollicularLymphoma, Intermediate-GradeLymphoma, Large-CellLymphoma, Low-GradeLymphoma, Mixed-CellLymphoma, Small-CellLeukemia, Lymphocytic, ChronicLeukemia, B-Cell, ChronicLeukemia, ProlymphocyticLeukemia, Small LymphocyticLymphoma, Small LymphocyticLymphoma, Lymphoplasmacytoid, CLLLymphoplasmacytoid Lymphoma, CLLCLLSLL

Keywords

humanized anti-CD20 veltuzumab (IMMU-106) administered subcutaneously

Outcome Measures

Primary Outcomes (1)

  • Safety/tolerability

    safety will be assessed by monitoring lab results and adverse events, which will be assessed every 3 months for up to 2 years.

    over 2 years after treatment

Study Arms (1)

veltuzumab

EXPERIMENTAL

veltuzumab is a humanized CD20 antibody administered subcutaneously in this study.

Biological: veltuzumab

Interventions

veltuzumabBIOLOGICAL

veltuzumab (hA20) will be studied at different dose levels, administered subcutaneously once a week for 4 weeks.

Also known as: hA20, humanized anti-CD20, IMMU-106
veltuzumab

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed diagnosis of CD20 positive chronic lymphocytic leukemia (CLL)
  • Either previously untreated or relapsed
  • Measurable disease (at least one lesion \> 1.5 cm for NHL, or ALC \> 5,000 for CLL) see full protocol for additional criteria

You may not qualify if:

  • Previously untreated NHL patients with Stage I and II disease (Ann Arbor classification)
  • Previously untreated CLL patients with Stage 0-2 disease (Rai classification) unless specific treatment indications by NCCN guidelines exist (symptomatic, recurrent infections, end-organ function, cytopenias and steady disease progression).
  • see full protocol for additional criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Lewis Cancer Center and Research Pavilion

Savannah, Georgia, 31405, United States

Location

Cancer Care at Saint Clare's/Saint Clares Hospital Oncology & Hematology Specialists, P.A.

Denville, New Jersey, 07834, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07950, United States

Location

New York Hospital Weill Cornell Medical Center

New York, New York, 10021, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Related Publications (9)

  • Morschhauser F, Leonard JP, Coiffier B Petillon M, Coleman M,. Bahkti A, Teoh N, Wegener WA, Goldenberg DM. Phase I/II result of a second-generation humanized anti-CD20 antibody, IMMU-106 (.hA20), in NHL: 2006 ASCO Annual Meeting.Proceedings; 24/18S Part I of II:429s.

    BACKGROUND

  • Morschhauser F, Leonard JP, Fayad L, Coiffier B, Petillon M, Coleman M,. Horne H, Teoh N, Wegener WA, Goldenberg DM. Low doses of humanized anti-CD20 antibody, IMMU-106 (hA20), in refractory or recurrent NHL: Phase I/II results. 2007 ASCO Annual Meeting.Proceedings; 25/18S Part I of II:449s.

    BACKGROUND

  • Stein R, Qu Z, Chen S, Rosario A, Shi V, Hayes M, Horak ID, Hansen HJ, Goldenberg DM. Characterization of a new humanized anti-CD20 monoclonal antibody, IMMU-106, and Its use in combination with the humanized anti-CD22 antibody, epratuzumab, for the therapy of non-Hodgkin's lymphoma. Clin Cancer Res. 2004 Apr 15;10(8):2868-78. doi: 10.1158/1078-0432.ccr-03-0493.

    PMID: 15102696BACKGROUND

  • Sapra P, et al. Preclinical pharmacology and toxicology of humanized anti-B-cell antibodies (anti-CD22 and anti-CD20) in cynomolgus monkeys (CM). (Abstract #1471) Blood 2005; 106/11:424a.

    BACKGROUND

  • Stein R, et al. Mechanisms of anti-lymphoma effects of a new humanized anti-CD20 monoclonal antibody, IMMU-106. (Abstract No. 4917) Blood 2003; 102/11:

    BACKGROUND

  • Goldenberg DM, et al. Characterization and preclinical efficacy of hA20, a humanized anti-CD20 monoclonal antibody, for the treatment of NHL. (Abstract #2393) Proceedings of ASCO 2003; 22:595

    BACKGROUND

  • Goldenberg DM, et al. Characterization of new, chimeric and humanized, anti-CD20 monoclonal antibodies, cA20 and hA20, with equivalent efficacy to rituximab in-vitro and in xenografted human non-Hodgkin's lymphoma. (Abstract #2260) Blood 2002; 100/11:575a-576a.

    BACKGROUND

  • Kalaycio ME, George Negrea O, Allen SL, Rai KR, Abbasi RM, Horne H, Wegener WA, Goldenberg DM. Subcutaneous injections of low doses of humanized anti-CD20 veltuzumab: a phase I study in chronic lymphocytic leukemia. Leuk Lymphoma. 2016;57(4):803-11. doi: 10.3109/10428194.2015.1085531. Epub 2015 Oct 19.

    PMID: 26389849DERIVED

  • Negrea GO, Elstrom R, Allen SL, Rai KR, Abbasi RM, Farber CM, Teoh N, Horne H, Wegener WA, Goldenberg DM. Subcutaneous injections of low-dose veltuzumab (humanized anti-CD20 antibody) are safe and active in patients with indolent non-Hodgkin's lymphoma. Haematologica. 2011 Apr;96(4):567-73. doi: 10.3324/haematol.2010.037390. Epub 2010 Dec 20.

    PMID: 21173095DERIVED

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLymphoma, B-CellLymphoma, FollicularDendritic Cell Sarcoma, InterdigitatingLeukemia, Lymphocytic, Chronic, B-CellLeukemia, ProlymphocyticLeukemia

Interventions

veltuzumab

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHistiocytic Disorders, MalignantHistiocytosisLeukemia, B-CellLeukemia, LymphoidHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • William Wegener, MD, PhD

    Gilead Sciences

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 17, 2007

First Posted

October 19, 2007

Study Start

January 1, 2008

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

August 16, 2021

Record last verified: 2013-03

Locations

US(5)