NCT02104427 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2021-04-19

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

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

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

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 \< 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.
healthy Volunteers: false
maximum Age: 75 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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
intervention Names
Drug: TG-0054 combined with G-CSF
label
TG-0054 combined with G-CSF
type
EXPERIMENTAL

interventions

arm Group Labels
TG-0054 combined with G-CSF
name
TG-0054 combined with G-CSF
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 12
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
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

secondary Outcomes

description
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.
measure
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
description
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.
measure
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
description
determine circulating CD34+ cell counts in peripheral blood
measure
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)

Full study description

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.

Source references

references

citation
Sukhtankar DD, Cardarelli PM, Jalilizeinali B, Setia G, Kim G, Chang LW, Tsai CY, Caculitan NG, Schuster MW. Burixafor, a CXCR4 inhibitor with a differentiated kinetics profile: results of a phase 2 study for rapid cell mobilization in multiple myeloma and lymphoma patients undergoing transplant. Ann Hematol. 2026 Feb 4;105(3):86. doi: 10.1007/s00277-026-06858-9.
pmid
41636886
type
DERIVED
citation
Pan KS, Wang Z, Pfeil C, Bergkamp ND, Mobach S, Roth S, Rizk A, Lohse MJ, Annibale P, Siderius M, Zimmermann M, Smit MJ, Bosma R. Pharmacological characterization of a clinical candidate, TG-0054, a small molecule inverse agonist targeting CXCR4. Mol Pharmacol. 2025 Apr;107(4):100015. doi: 10.1016/j.molpha.2025.100015. Epub 2025 Jan 31.
pmid
40156952
type
DERIVED

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-67d18bb53d54206453e6
requested nct id
NCT02104427
primary nct id
NCT02104427
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
payload sha256
245b1329663d84f2a77cd8a236d9f29e68063b246365fbdf9875fbbc1c3e6bb4
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-67d18bb53d54206453e6
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT02104427
occurrences
context exact
NCT02104427
end
11
exact text
NCT02104427
start
0
offset unit
unicode_code_points
query cond
Plasma Cell Neoplasms
query disease state id
ds-plasma-cell-neoplasms
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
source json pointer
/studies/606/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
37d76b9a4c1d170d1eea27396859072fd2784e13d8edaa996a6d4c077f3ef0eb
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice