- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02104427
PD and Safety of TG-0054 Combined With G-CSF in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients
April 14, 2021 updated by: GPCR Therapeutics, Inc.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Stony Brook, New York, United States, 11794
- Stony Brook University Hospital
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Tennessee
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Nashville, Tennessee, United States, 37203
- Tennessee Oncology, PLLC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- At least one year post-menopausal, or
- Surgically sterile, or
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Day 5 to Day 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Day 5 to Day 8
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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
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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.
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Day 5 to Day 9
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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)
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determine circulating CD34+ cell counts in peripheral blood
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Day 5 (1st leukapheresis session) to Day 6 (2nd leukapheresis session)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael M Schuster, MD, Stony Brook University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
March 26, 2014
First Submitted That Met QC Criteria
April 1, 2014
First Posted (Estimate)
April 4, 2014
Study Record Updates
Last Update Posted (Actual)
April 19, 2021
Last Update Submitted That Met QC Criteria
April 14, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Lymphoma
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Hodgkin Disease
- Lymphoma, Non-Hodgkin
Other Study ID Numbers
- TG-0054-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Myeloma
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Lawson Health Research InstituteThe Ottawa Hospital; Hamilton Health Sciences Corporation; Dalhousie University; Niagara Health SystemActive, not recruitingMultiple Myeloma in Relapse | Multiple Myeloma With Failed Remission | Multiple Myeloma Stage I | Multiple Myeloma Progression | Multiple Myeloma Stage II | Multiple Myeloma Stage IIICanada
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National Cancer Institute (NCI)Active, not recruitingSmoldering Multiple Myeloma | Refractory Multiple Myeloma | DS Stage I Multiple Myeloma | DS Stage II Multiple Myeloma | DS Stage III Multiple MyelomaUnited States
-
Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
City of Hope Medical CenterCompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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University of WashingtonNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
Clinical Trials on TG-0054 combined with G-CSF
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Peking University People's HospitalWithdrawn
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Shanghai Cancer Hospital, ChinaRecruiting
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Japan Clinical Oncology GroupMinistry of Health, Labour and Welfare, JapanCompleted
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Hospital Sao RafaelCompletedChronic Chagasic MyocarditisBrazil
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European Society for Blood and Marrow TransplantationCHUGAI sanofi-aventisTerminatedAplastic AnaemiaFrance, Netherlands, Germany, United Kingdom, Switzerland, Italy, Sweden, Greece, Czechia
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Second Affiliated Hospital of Soochow UniversityNot yet recruiting
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Seoul National University HospitalUnknown
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Maria Sklodowska-Curie National Research Institute...UnknownHodgkin's Lymphoma | Non-Hodgkin's LymphomaPoland
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Proteonomix, Inc.University of Medicine and Dentistry of New Jersey; NumodaUnknownEnd Stage Liver DIseaseUnited States
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Second Affiliated Hospital of Soochow UniversityNot yet recruiting