Phase 2
N=12
PD and Safety of TG-0054 Combined With G-CSF in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients
Multiple Myeloma · Non-Hodgkin Lymphoma · Hodgkin Disease
Bottom Line
View on ClinicalTrials.gov: NCT02104427 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: 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 — 0.50000; 0.9167; 0.9167; 0.9167 Proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TG-0054 combined with G-CSF (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GPCR Therapeutics, Inc.
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
0.50000; 0.9167; 0.9167; 0.9167; 0.6667; 0.8889 | — |
| SECONDARY 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 |
0.9167; 0.9167; 0.9167; 0.9167; 0.8889; 0.8889 | — |
| SECONDARY Proportion of Patients Who Mobilized the Targeted Total Number of CD34+ Cells (≥6.0 x 10^6 Cells/kg) Within 5 Leukapheresis Sessions |
0.5000; 0.6667; 0.6667; 0.6667; 0.6667; 0.6667 | — |
| SECONDARY the Pharmacodynamics (PD) Following Treatment With TG-0054 When Combined With G-CSF |
32.50; 43.50; 42.00; 60.50; 35.50; 16.00 | — |
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.
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT02104427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.