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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

October 13, 2011
March 25, 2014
October 2012
July 2013   (final data collection date for primary outcome measure)
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 ]
Total number of HSCs collected within 4 leukapheresis sessions after TG-0054 (3.14 mg/kg) alone or in combination with G-CSF mobilization in patients with multiple myeloma, non-Hodgkins's lymphoma or Hodgkin's disease. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01458288 on ClinicalTrials.gov Archive Site
  • 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.
  • The average number of leukapheresis sessions required to collect greater or equal to 2 x10^6 CD34+ cells/kg or greater or equal to 5 x10^6 CD34+ cells/kg. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • The safety of TG-0054 in patients with multiple myeloma, non-Hodgkins's lymphoma or Hodgkin's disease [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    All adverse events will be coded according to the MedDRA dictionary, and be limited to events related or not related to study drug.
  • The PK of TG-0054 [ Time Frame: pre-dose, -2,0,4,8,12,16,24,36,48,and 72 hr after dosing. ] [ Designated as safety issue: No ]
    Pharmacokinetics parameters include Cmax, Area Under Curve, Tmax, Ae%, and T1/2.
Not Provided
Not Provided
 
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
Not Provided

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Multiple Myeloma
  • Non-hodgkin's Lymphoma
  • Hodgkin's Disease
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
Experimental: TG-0054 (3.14 mg/kg)
TG-0054 (3.14 mg/kg)
Intervention: Drug: TG-0054
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
July 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01458288
TG-0054-03
Not Provided
TaiGen Biotechnology Co., Ltd.
TaiGen Biotechnology Co., Ltd.
Not Provided
Principal Investigator: Michael W. Schuster, M.D. Stony Brook University Hospital
TaiGen Biotechnology Co., Ltd.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP