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:
Information provided by (Responsible Party):
TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01458288
First received: October 13, 2011
Last updated: March 25, 2014
Last verified: March 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To determine the total number of HSCs collected within four leukapheresis sessions after TG-0054 (3.14 mg/kg) alone or in combination with G-CSF mobilization in patients with Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the average number of leukapheresis sessions [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT01458288     History of Changes
Other Study ID Numbers: TG-0054-03
Study First Received: October 13, 2011
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration
Taiwan: Department of Health

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
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

ClinicalTrials.gov processed this record on April 20, 2014