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Safety and PK/PD of TG-0054 in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01018979
First received: November 24, 2009
Last updated: November 29, 2013
Last verified: November 2013
  Purpose

A phase II study to evaluate the safety, pharmacokinetics, and hematopoietic stem cell mobilization of TG-0054 in patients with multiple myeloma, non-Hodgkin lymphoma or Hodgkin disease.


Condition Intervention Phase
Multiple Myeloma
Non-Hodgkin Lymphoma
Hodgkin Disease
Drug: TG-0054
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Open-Label, Multi-Center Study to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 in Patients With Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease

Resource links provided by NLM:


Further study details as provided by TaiGen Biotechnology Co., Ltd.:

Primary Outcome Measures:
  • To determine whether TG-0054 can achieve the mobilization success of hematopoietic stem cells in patients with multiple myeloma, non-Hodgkin lymphoma or Hodgkin disease. [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety and pharmacokinetics of TG-0054 in patients with MM, NHL or HD [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: February 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TG-0054 (3.14 mg/kg) Drug: TG-0054
3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female 18 to 70 years of age inclusive
  • Patients with confirmed pathology diagnosis of MM, NHL or HD
  • Potential candidate for autologous stem cell transplantation at Investigator's discretion
  • ≦ 2 prior regimens of cytotoxic chemotherapy (rituximab, thalidomide, and bortezomib will not be considered as cytotoxic chemotherapy)
  • > 4 weeks since last cycle of chemotherapy prior to the study drug administration
  • Total dose of melphalan received ≦ 200 mg in the most recent chemotherapy treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Recovered from all acute toxic effects of prior chemotherapy at Investigator's discretion
  • White blood cell (WBC) count ≧ 3.0 x 109/L on screening laboratory assessments
  • Absolute neutrophil count ≧ 1.5 x 109/L on screening laboratory assessments
  • Platelet count ≧ 100 x 109/L on screening laboratory assessments
  • Serum creatinine ≦ 2.2 mg/dL on screening laboratory assessments
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin < 2 x upper limit of normal (ULN) on screening laboratory assessments
  • Negative for human immunodeficiency virus (HIV)
  • Adequate cardiac and pulmonary function to undergo leukapheresis at Investigator's discretion
  • For females, one of the following criteria must be fulfilled:

    1. At least one year post-menopausal, or
    2. Surgically sterile, or
    3. Willing to use a double-barrier method [intrauterine device (IUD) plus condom, spermicidal gel plus condom] of contraception throughout the study
  • Males must be willing to use a reliable form of contraception (use of a condom or a partner fulfilling the above criteria) from study Day 1 until 28 days after the last dose of TG-0054
  • Able to provide the signed informed consent

Exclusion Criteria:

  • Received radiation therapy around the pelvic or spinal area within 6 months prior to the study drug administration
  • >10% bone marrow involvement of lymphoma in NHL patients
  • Failed previous stem cell collection [failed to collect 2 x 106 CD34+ cells/kg within 4 apheresis sessions after receiving granulocyte colony-stimulating factor (G-CSF)]
  • Patients who have undergone previous stem cell transplantation procedure
  • Received G-CSF within 2 weeks prior to the study drug administration
  • History of other cancer within the past 5 years excluding MM, NHL, HD, basal cell or squamous cell carcinoma of the skin
  • History of other hematologic disorders including bleeding or thromboembolic disease
  • History of poor and uncontrollable cardiovascular or pulmonary disease such as myocardial infarction, cardiac arrhythmias, transient ischemic attack, stroke or Chronic Obstructive Pulmonary Disease (COPD) patients hospitalized more than two times a year due to underlying disease
  • Diagnosis of sickle cell anemia or documented sickle cell trait
  • Uncontrollable malignancy with MM, NHL or HD, or carcinomatous meningitis, at Investigator's discretion
  • Any infection required antibiotic treatment or unexplained fever above 38 °C within 3 days prior to dosing
  • Pregnant or breast-feeding
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
  • Received any other investigational drug within 1 month before entering the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018979

Locations
Taiwan
Chang-Gung Memorial Hospital Chiayi
Chiayi, Taiwan
Buddist Tzu Chi General Hospital
Hualien, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung, Taiwan
Chang-Gung Memorial Hospital Linkou
Linkou, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Sponsors and Collaborators
TaiGen Biotechnology Co., Ltd.
Investigators
Principal Investigator: Tzeon-Jye Chiou, MD Taipei Veterans General Hospital, Taiwan
Principal Investigator: Tso-Fu Wang, MD Buddist Tzu Chi General Hospital
Principal Investigator: Sheng-Fung Lin, MD Kaohsiung Medical University
Principal Investigator: Chih-Cheng Chen, MD Chang-Gung Memorial Hospital Chiayi
Principal Investigator: Po-Nan Wang, MD Chang-Gung Memorial Hospital Linkou
Principal Investigator: Jih-Luh Tang, MD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT01018979     History of Changes
Other Study ID Numbers: TG-0054-02
Study First Received: November 24, 2009
Last Updated: November 29, 2013
Health Authority: Taiwan: Department of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014