Know Cancer

or
forgot password

A Phase 2a Open-Label Multi-Center Study Evaluating HQK-1004 Administered With Valganciclovir in Patients With Relapsed or Refractory Epstein-Barr Virus-Positive Lymphoid Malignancies or Lymphoproliferative Disorders


Phase 2
3 Years
N/A
Not Enrolling
Both
Lymphoid Malignancies, Lymphoproliferative Disorders

Thank you

Trial Information

A Phase 2a Open-Label Multi-Center Study Evaluating HQK-1004 Administered With Valganciclovir in Patients With Relapsed or Refractory Epstein-Barr Virus-Positive Lymphoid Malignancies or Lymphoproliferative Disorders


Inclusion Criteria:



- Histologically confirmed lymphoid malignancy or lymphoproliferative disorder with EBV
detected by either immunohistochemistry or in situ hybridization. Pathology can be
assessed on either a current or previous biopsy. All disease stages are eligible

- Disease that is refractory or relapsed after at least one prior standard therapeutic
regimen, which includes biologic agents (e.g., monoclonal antibodies), chemotherapy
or chemoradiotherapy regimens. Prior therapy may include high dose chemotherapy and
stem cell rescue or bone marrow transplantation

- Bidimensionally measurable disease by computerized tomography (CT) or magnetic
resonance imaging (MRI; patients with sensitivity to contrast or for tumor types that
are less accurately measured by CT) scan or physical measurement (cutaneous lesions
only) with at least 1 lesion ≥ 10 mm in the greatest diameter. PET-CT should be used
at baseline for patients with Hodgkin's Disease (HD) or diffuse large B-cell lymphoma
(DLBCL).

- Absolute neutrophil count ≥ 500/mm3 and platelet count ≥ 50,000/mm3

- Bilirubin ≤ 2.0 times upper limit of normal (ULN) with the exception of patients with
Gilbert's syndrome (bilirubin ≤ 3.5 times ULN allowed), and both AST and ALT ≤ 3
times ULN

- Serum creatinine ≤ 2.0 mg/dL

Exclusion Criteria:

- Patients who have not recovered from previous treatment with chemotherapy

- Patients who have been treated with biologic agents within two weeks prior to first
dose of HQK-1004

- Uncontrolled ischemic heart disease or uncontrolled congestive heart failure, or
myocardial infarction within the past 3 months

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Time Frame:

Days 21, 42, 84 and 126

Safety Issue:

No

Principal Investigator

Ron Berenson, MD

Investigator Role:

Study Director

Investigator Affiliation:

HemaQuest Pharmaceuticals Inc.

Authority:

United States: Food and Drug Administration

Study ID:

HQP-1004-EB-03

NCT ID:

NCT00992732

Start Date:

May 2010

Completion Date:

Related Keywords:

  • Lymphoid Malignancies
  • Lymphoproliferative Disorders
  • Neoplasms
  • Lymphoproliferative Disorders

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Hackensack University Medical CenterHackensack, New Jersey  07601
University of California, San FranciscoSan Francisco, California  94143
Northwestern University Feinberg School of MedicineChicago, Illinois  60611
Weill Cornell Medical CollegeNew York, New York  10021
LPCH/StanfordPalo Alto, California  94304
Feigin Center - Center for Cell and Gene TherapyHouston, Texas  77030