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PD and Safety of TG-0054 Combined With G-CSF in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients

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ClinicalTrials.gov Identifier: NCT02104427
Recruitment Status : Completed
First Posted : April 4, 2014
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
TaiGen Biotechnology Co., Ltd.

Brief Summary:
This is a phase II study to evaluate the efficacy and safety of TG-0054 combined with G-CSF in mobilizing hematopoietic stem cells in patients with multiple myeloma, non-Hodgkin lymphoma or Hodgkin disease.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Non-Hodgkin Lymphoma Hodgkin Disease Drug: TG-0054 combined with G-CSF Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open-Label Study to Evaluate the Hematopoietic Stem Cell Mobilization of TG-0054 Combined With G-CSF in Patients With Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease
Study Start Date : February 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015


Arm Intervention/treatment
Experimental: TG-0054 combined with G-CSF
1. G-CSF: 10 μg/kg/day, administrated via SC injections from Day 1 to Day 8; 2. TG-0054: 3.14 mg/kg, administrated via 15-min IV infusion from Day 5 to Day 9 as needed to reach the target collection goal
Drug: TG-0054 combined with G-CSF



Primary Outcome Measures :
  1. Proportion of Patients From Whom a Total Number of CD34+ Cells ≥5.0 x 10^6 Cells/kg Was Collected Within the First 4 Leukapheresis Sessions [ Time Frame: Day 5 to Day 8 ]
    The primary efficacy endpoint was the proportion of patients from whom a total number of CD34+ cells ≥5.0 x 10^6 cells/kg was collected within the first 4 leukapheresis sessions. For the primary efficacy endpoint, each patient's CD34+ cell number was calculated as the sum of CD34+ cell numbers collected from (up to) the first 4 leukapheresis sessions.


Secondary Outcome Measures :
  1. Proportion of Patients From Whom a Total Number of CD34+ Cells ≥2.5 x 10^6 Cells/kg Was Collected Within the First 4 Leukapheresis Sessions [ Time Frame: Day 5 to Day 8 ]
    The secondary efficacy endpoint was the proportion of patients from whom a total number of CD34+ cells ≥2.5 x 10^6 cells/kg was collected within the first 4 leukapheresis sessions. Each patient's CD34+ cell number was calculated as the sum of CD34+ cell numbers collected from (up to) the first 4 leukapheresis sessions.

  2. Proportion of Patients Who Mobilized the Targeted Total Number of CD34+ Cells (≥6.0 x 10^6 Cells/kg) Within 5 Leukapheresis Sessions [ Time Frame: Day 5 to Day 9 ]
    The secondary efficacy endpoint was the proportion of patients from whom a total number of CD34+ cells ≥6.0 x 10^6 cells/kg was collected within 5 leukapheresis sessions. Each patient's CD34+ cell number was calculated as the sum of CD34+ cell numbers collected from (up to) 5 leukapheresis sessions.

  3. the Pharmacodynamics (PD) Following Treatment With TG-0054 When Combined With G-CSF [ Time Frame: Day 5 (1st leukapheresis session) to Day 6 (2nd leukapheresis session) ]
    determine circulating CD34+ cell counts in peripheral blood



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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*10^9/L on screening laboratory assessments;
  • Absolute neutrophil count ≧ 1.5*10^9/L on screening laboratory assessments;
  • Platelet count ≧ 100*10^9/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 2.0*10^6 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.

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): NCT02104427


Locations
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United States, New York
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
TaiGen Biotechnology Co., Ltd.
Investigators
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Principal Investigator: Michael M Schuster, MD Stony Brook University Hospital

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Responsible Party: TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT02104427     History of Changes
Other Study ID Numbers: TG-0054-04
First Posted: April 4, 2014    Key Record Dates
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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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
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs