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

NCT02104427 | Completed Phase 2 Results

• 1 other identifier: TG-0054-04
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Myeloma; Non-Hodgkin Lymphoma; Hodgkin Disease

Outcome Measures

Primary Outcomes (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

  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.

  Day 5 to Day 8

Secondary Outcomes (3)

• 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

  Day 5 to Day 8

• Proportion of Patients Who Mobilized the Targeted Total Number of CD34+ Cells (≥6.0 x 10^6 Cells/kg) Within 5 Leukapheresis Sessions

  Day 5 to Day 9

• the Pharmacodynamics (PD) Following Treatment With TG-0054 When Combined With G-CSF

  Day 5 (1st leukapheresis session) to Day 6 (2nd leukapheresis session)

Study Arms (1)

TG-0054 combined with G-CSF

EXPERIMENTAL

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

Interventions

TG-0054 combined with G-CSF DRUG

TG-0054 combined with G-CSF

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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;

Sponsors & Collaborators

• GPCR Therapeutics, Inc.: lead

Study Sites (2)

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma, Non-Hodgkin; Hodgkin Disease

Interventions

Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphoma; Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Li-Wen Chang
• Organization: TaiGen Biotechnology Co., Ltd.

lwchang@taigenbiotech.com

+886-2-8177-7072

Study Officials

• Michael M Schuster, MD

  Stony Brook University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2014
• First Posted: April 4, 2014
• Study Start: February 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 19, 2021
• Results First Posted: December 13, 2017

Record last verified: 2021-04

Locations

US (2)