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

NCT ID: NCT01458288

Last Updated: 2021-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-07-31

Brief Summary

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.

Conditions

Multiple Myeloma; Non-hodgkin's Lymphoma; Hodgkin's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TG-0054 (3.14 mg/kg)

TG-0054 (3.14 mg/kg)

Group Type: EXPERIMENTAL

TG-0054

Intervention Type: DRUG

3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)

Interventions

TG-0054

3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)

Intervention Type: DRUG

Other Intervention Names

burixafor

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GPCR Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael W. Schuster, M.D.

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University Hospital

Locations

Stony Brook University Hospital

Stony Brook, New York, United States

Countries

United States

Other Identifiers

TG-0054-03

Identifier Type: -

Identifier Source: org_study_id