We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 Alone or in Combination With G-CSF in Patients With Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01458288
First Posted: October 24, 2011
Last Update Posted: January 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
TaiGen Biotechnology Co., Ltd.
  Purpose
This Phase II study is to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 alone or in combination with G-CSF in Patients with Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Patients Achieving the CD34+ Hematopoietic Stem Cell (HSC) Mobilization Target of ≧2.5×1000000 Cells/kg [ Time Frame: 1 week ]

    Patients were all with multiple myeloma (MM), Non-Hodgkin lymphoma (NHL) or Hodgkin disease (HD).

    Number of patients who mobilized the targeted total number of CD34+ cells within a maximum of 4 leukapheresis sessions in study arm 1 and arm 3. Patients in arm 1 followed administration of TG-0054 (3.14 mg/kg) alone and leukapheresis start from study day 1. Patients in arm 3 followed administration of TG-0054 (3.14 mg/kg) combined with granulocyte colony-stimulating factor (G-CSF) and leukapheresis start from study day 8.



Secondary Outcome Measures:
  • the Average Number of Leukapheresis Sessions [ Time Frame: 1 week ]
    To determine the average number of leukapheresis sessions required to collect 2.5 x106 CD34+ cells/kg.

  • the Safety of TG-0054 in Patients With MM, NHL or HD [ Time Frame: 1 month ]
    To evaluate the safety of TG-0054 in patients with MM, NHL or HD All adverse events will be coded according to the MedDRA dictionary, and be limited to events related or not related to study drug.

  • the Pharmacodynamics (PD) of TG-0054 [ Time Frame: pre-dose(-2 to 0 h),2, 4 and 6 hr after dosing. ]
    To evaluate the pharmacodynamics (PD) of TG-0054 by determining circulating CD34+ cell counts in peripheral blood.


Enrollment: 12
Study Start Date: October 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TG-0054 (3.14 mg/kg)
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 four leukapheresis sessions)
Other Name: burixafor

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female 18 to 75 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;
  • 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 from study Day 1 until 28 days after the last dose of TG-0054;
  • 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 to the pelvis;
  • Received > 6 cycles of lenalidomide;
  • Evidence of bone marrow involvement of lymphoma in NHL patients;
  • Failed previous stem cell collection [failed to collect 2 x 106 CD34+ cells/kg within 4 leukapheresis 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 being treated with anti-coagulant;
  • 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;
  • Patients with proliferative retinopathy;
  • 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;
  • Received prior treatment with TG-0054 but withdrew early from this study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01458288


Locations
United States, New York
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
TaiGen Biotechnology Co., Ltd.
Investigators
Principal Investigator: Michael W. Schuster, M.D. Stony Brook University Hospital
  More Information

Responsible Party: TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT01458288     History of Changes
Other Study ID Numbers: TG-0054-03
First Submitted: October 13, 2011
First Posted: October 24, 2011
Results First Submitted: December 16, 2014
Results First Posted: January 8, 2015
Last Update Posted: January 8, 2015
Last Verified: December 2014

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