NCT00103779

Brief Summary

This is an open-label, multi-dose, Phase I, dose escalation study to define the safety profile and preliminary anti-tumor activity of SGN-40 in patients with refractory or recurrent non-Hodgkin B-cell lymphomas.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2004

Typical duration 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

Study Start

First participant enrolled

December 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

December 18, 2014

Status Verified

December 1, 2014

Enrollment Period

2.2 years

First QC Date

February 14, 2005

Last Update Submit

December 17, 2014

Conditions

Non-Hodgkin Lymphoma

Keywords

Antigens, CD40Antibody, MonoclonalLymphoma, Non-HodgkinLymphoma, B-CellHematologic DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphoproliferative DisordersLymphoma

Outcome Measures

Primary Outcomes (1)

  • Adverse events and lab abnormalities.

Study Arms (1)

1

EXPERIMENTAL
Drug: SGN-40 (anti-huCD40 mAb)

Interventions

SGN-40 (anti-huCD40 mAb)DRUG

1 mg/kg IV (in the vein) on Day 1; 1-2 mg/kg IV on Day 4; 2-4 mg/kg IV on Day 8; 3-8 mg/kg on Days 15, 22 and 29.

Also known as: dacetuzumab
1

Eligibility Criteria

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

You may qualify if:

  • Patients must have a histological diagnosis of B cell non-Hodgkin's lymphoma, including diffuse large B-cell, mantle cell, follicular, small lymphocytic, and marginal zone lymphoma by the World Health Organization criteria.
  • Patients must have an archived paraffin or fresh tumor specimen available for immunohistologic evaluation of CD40, CD20, \& CD79a.
  • Patients must have relapsed lymphoma and must have failed frontline chemotherapy.
  • Patients who have not received autologous stem cell transplant must have refused or be ineligible for it.
  • Patients must have completed radiotherapy, chemotherapy, and/or treatment with investigational anti-cancer agents 4 weeks prior to registration. Patients must have completed any monoclonal antibody treatment, including rituximab, 6 months prior to registration.
  • Patients must have completed autologous bone marrow transplant 4 months prior to registration.
  • Patient must have at least one site of measurable disease defined by unidimensional lesion ≥ 2 cm by conventional CT scan.
  • Patients must have an ECOG performance status ≤ 2 and a life expectancy \> 3 months.
  • Patients must have the following required baseline laboratory data:
  • Platelet count ≥ 75,000/mm3,
  • Hemoglobin ≥ 9.0 g/dL,
  • Absolute neutrophil count ≥ 1,250/mm3,
  • ALT/AST ≤ 2.5 times ULN,
  • Total bilirubin ≤ 1.5 times ULN,
  • Creatinine \< 1.5 mg/dL,
  • +4 more criteria

You may not qualify if:

  • Patients with history or clinical evidence of leptomeningeal or central nervous system (CNS) lymphoma.
  • Patients with a documented history within 6 months of registration of a cerebral vascular event, myocardial infarction, deep venous thrombosis or other vascular event that has required medical or surgical intervention. Patients must have completed anticoagulant therapy at least 3 months prior to registration. Prophylactic anticoagulant therapy for indwelling catheters is acceptable.
  • Patients who have received an allogeneic stem cell transplant.
  • Patients who have had major surgery within 4 weeks prior to registration.
  • Patients with a known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation.
  • Patients with a history of another primary malignancy that has not been in remission for at least 5 years (non-melanoma skin cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear are exempt from the five year limit).
  • Patients with any active systemic viral, bacterial, or fungal infection within four weeks prior to registration.
  • Patients with known positivity for HIV, hepatitis B or hepatitis C infection.
  • Patients with a history of significant chronic or recurrent infections requiring treatment.
  • Patients with a history of migraines or severe headaches requiring medical therapy within 12 months of enrollment.
  • Patients on systemic steroids who have not been on a stable daily dose (not exceeding 10 mg prednisone or equivalent) during 4 weeks prior to the first dose of SGN 40.
  • Patients who are pregnant or breastfeeding.
  • Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment.
  • Patients with dementia or altered mental status that would preclude the understanding and/or rendering of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Cornell University

New York, New York, 10029, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Advani R, Forero-Torres A, Furman RR, Rosenblatt JD, Younes A, Ren H, Harrop K, Whiting N, Drachman JG. Phase I study of the humanized anti-CD40 monoclonal antibody dacetuzumab in refractory or recurrent non-Hodgkin's lymphoma. J Clin Oncol. 2009 Sep 10;27(26):4371-7. doi: 10.1200/JCO.2008.21.3017. Epub 2009 Jul 27.

    PMID: 19636010RESULT

Related Links

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLymphoma, B-CellHematologic DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphoproliferative DisordersLymphoma

Interventions

dacetuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemic and Lymphatic DiseasesImmune System Diseases

Study Officials

  • Jonathan Drachman, MD

    Seagen Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Expanded Access
Yes

Study Record Dates

First Submitted

February 14, 2005

First Posted

February 15, 2005

Study Start

December 1, 2004

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

December 18, 2014

Record last verified: 2014-12

Locations

US(5)