Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Heart and Blood Diseases

Rare Diseases

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphosarcoma

Anti-Infective Agents

All Drugs and Chemicals

Plerixafor

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

Plerixafor administered at 16 hours prior to apheresis

Patricia A Shi, MD

Luis M Isola, MD

The purpose of this study is to determine whether it is safe and effective to collect peripheral blood hematopoietic stem cells 16 hours rather than the usual 11 hours after administration of plerixafor.

The current FDA-approved timing for plerixafor is approximately 11 hours prior to apheresis. This is a logistical problem, since plerixafor should be administered by a health care provider, given the risk of hypotension with administration. The primary purpose of this study is, in autologous donors with non-Hodgkins lymphoma and multiple myeloma undergoing hematopoietic progenitor cell mobilization with plerixafor and G-CSF, to determine whether the dosing interval can be increased to 16 hours prior to apheresis. Patients will be admitted to a special clinical research center on the 4th day of G-CSF administration, where the peripheral blood CD34+ count will be measured every 2 hours after plerixafor administration at 5 pm until 9 AM the following day, at which time apheresis will commence. The hypothesis is that plerixafor administration 16 hours prior to apheresis is as safe and effective as plerixafor administration at 11 hours prior to apheresis.

Study of the Best Timing for Plerixafor in Autologous Hematopoietic Stem Cell Collection

Mobilization Kinetics of Plerixafor and G-CSF in Patients With NHL and MM Undergoing Autologous Peripheral Blood Progenitor Cell Collection

Genzyme, a Sanofi Company

Shi, Patricia, M.D.

Assistant Professor, Hematology-Oncology

Hematologic Neoplasms

Antineoplastic Agents

Etoposide

Cytarabine

Etoposide phosphate

Enzyme Inhibitors

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

The combination regimen of etoposide, cytarabine and PEG-rhG-CSF.

PEG-rhG-CSF

Ying Lu

Peipei Ye

Gongqiang Wu

Huifang Jiang

Wenjuan Yu

Lihong Shou

Huixian Hu

Li Huang

Linjie Li

Jing Le

Weiying Feng

Weiguo Zhu

Jian Shen

Sai Chen

Ying Lin

This is a single-arm, multicenter, exploratory clinical study to evaluate the safety and efficacy of the combination of etoposide, cytarabine and PEG-rhG-CSF (EAP regimen) as first line mobilization regimen of hematopoietic stem cells in patients with lymphoma and multiple myeloma. All eligible patients will receive EAP regimen treatment, then the number of CD34+ cells and white blood cells will be monitoring. When the collection standard is met, hematopoietic stem cell collection will be started.

In patients older than 65 years, or with creatinine \>2.5 mg/dL but with an endogenous creatinine clearance \>50%, the dose of etoposide and Ara-C should be reduced by one-quarter to one-third.

Routinely blood analyses and peripheral blood CD34+ cells monitored will be performed daily from day 9 to the end of HSC collection or the abandonment of HSC collection. If the WBC count is ≤10×109/L, 5μg/kg/d of G-CSF should be injected subcutaneously until the end of HSC collection.

Leukapheresis can be performed when the white blood cell counts recover (WBC count was≥4×109/L) following chemotherapy and the CD34+ cell count was≥20/μL. Leukapheresis started if the peripheral blood CD34+ counts plateaued at ≥5 cells/μL and \<20 cells/μL after recovery of white blood cell counts following chemotherapy, the clinician decided whether to add plerixafor based on the specific situation of the patient. Leukapheresis should be abandoned if the peak circulating CD34+ cells were \<5/μL up to 20 days after chemotherapy. CD34+ cells were determined by multi-parameter flow cytometry and a dual-platform approach. Two blood cell separators were used at the study sites: Spectra-Optia Apheresis system (Terumo BCT, Lake-wood, CO, USA) , COM.TEC (Fresenius Kabi). During each leukapheresis, 2.5 times the patients' blood volume (±25%) had to be processed within 5 h.

Etoposide+Cytarabine+PEG-rhG-CSF as First Line Mobilization Regimen of Hematopoietic Stem Cells in Patients With Hematological Malignancies

Prospective, Single-arm, Multicenter Exploratory Clinical Study of the Combination of Etoposide, Cytarabine and PEG-rhG-CSF (EAP Regimen) as First Line Mobilization Regimen of Hematopoietic Stem Cells in Patients With Hematological Malignancies

The proportion of patients whose cells can be successfully mobilized and collected with a target CD34+ Hematopoietic Stem Cell (HSC) dose of ≥2×10\^6/kg.

The proportion of patients whose cells can be successfully mobilized and collected with a target CD34+ Hematopoietic Stem Cell (HSC) dose of \>5×10\^6/kg.

Incidence and severity of treatment related adverse events (TRAEs). Adverse events will be collected based on NCI CTCAE version 5.0.

To determine the time period from PEG-rhG-CSF mobilization to successfully collection of HSC.

The Affiliated People's Hospital of Ningbo University

Wenjuan O Yu

Li P Huang

Linjie C Li

Weiying Z Feng

Weiguo S Zhu

Jian Z Shen

This is a single-arm, multicenter, exploratory clinical study to evaluate the safety and efficacy of the combination of etoposide, cytarabine and PEG-rhG-CSF (EAP regimen) on hematopoietic stem cell mobilization in poor mobilization patients with hematological malignancies. All eligible patients will receive EAP regimen treatment, then the number of CD34+ cells and white blood cells will be monitoring. When the collection standard is met, hematopoietic stem cell collection will be started.

Etoposide+Cytarabine+PEG-rhG-CSF for Hematopoietic Stem Cell Mobilization in Patients With Hematological Malignancies

Prospective, Single-arm, Multicenter Exploratory Clinical Study of the Combination of Etoposide, Cytarabine and PEG-rhG-CSF (EAP Regimen) on Hematopoietic Stem Cell Mobilization in Poor Mobilization Patients With Hematological Malignancies

Antirheumatic Agents

Cyclophosphamide

Antineoplastic Agents, Alkylating

Alkylating Agents

Subject will receive chemotherapy with intermediate-dose CTX 2.5/m2 for 2 days. 10 ug/kg/d of G-CSFwas administered from the WBC was lower than 1×10\^9/L following bejing of chemotherapy or no later than day 7after chemotherapy. G-CSF was subcutaneously administered once daily until the stem cell collection was completed. rhTPO was administered 15 000 U/d once daily by subcutaneous injection from day 5-7 after chemotherapy and until the stem cell collection was completed.

Subject will receive chemotherapy with intermediate-dose CTX 2.5/m2 for 2 days. 10 ug/kg/d of G-CSF was administered from the WBC was lower than 1×10\^9/L following bejing of chemotherapy or no later than day 7after chemotherapy. G-CSF was subcutaneously administered once daily until the stem cell collection was completed.

rhTPO was administered 15 000 U/d once daily by subcutaneous injection from day 5-7 after chemotherapy and until the stem cell collection was completed.

rhTPO

10 ug/kg/d of G-CSFwas administered from the WBC was lower than 1×10\^9/L following bejing of chemotherapy or no later than day 7after chemotherapy. G-CSF was subcutaneously administered once daily until the stem cell collection was completed.

-CSF

Guorong Wang, doctor

Wenming Chen, doctor

Comparing intermediate-dose CTX (ID-CTX)and G-CSF with rhTPO or without for peripheral blood stem cell mobilization in patients with multiple myeloma, try to find out whether rhTPO combined to ID-CTX + G-CSF could improve the results of peripheral blood stem cell mobilization.

The purpose of this study is to try to find out whether rhTPO combined to ID-CTX + G-CSF could improve the results of peripheral blood stem cell mobilization. Comparing ID-CTX and G-CSF plus rhTPO or not for peripheral blood stem cell mobilization in patients with multiple myeloma. rhTPO15000U/d were given from day 5\~7 after chemotherapy until the stem cell collection .

Comparing Intermediate-dose CTX+ G-CSF Plus or Not rhTPO for PB CD34+ Cells Mobilization in MM Patients

A Prospective Control Study of Comparing Intermediate-dose Cyclophosphamide(ID-CTX) and G-CSF Plus or Not Recombinant Human Thrombopoietin (rhTPO) for PBSC Mobilization in Patients With Multiple Myeloma

Wang Guorong

Clinical Professor

Hodgkin Disease

Hodgkin Lymphoma

Lenograstim

240 µg/kg SC AMD3100 Day -5

10 µg/kg SC G-CSF Day -4 thru Day -1

160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1

Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)

240 µg/kg SC AMD3100 Day -5

10 µg/kg SC G-CSF Day -4 thru Day -1

240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1

Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)

240 µg/kg SC AMD3100 Day -5

10 µg/kg SC G-CSF Day -4 thru Day -1

320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1

Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)

240 µg/kg SC AMD3100 Day -5

10 µg/kg SC G-CSF Day -4 thru Day -1

400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1

Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)

240 µg/kg SC AMD3100 Day -5

10 µg/kg SC G-CSF Day -4 thru Day -1

MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1

Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)

AMD3100

G-CSF

Apheresis

Amanda F. Cashen, M.D.

This study will evaluate the safety and efficacy of intravenous AMD3100 added to a standard G-CSF mobilization regimen of patients undergoing autologous stem cell transplantation for lymphoma.

The investigators hypothesize that after stem cell mobilization with G-CSF plus IV AMD3100, a significantly higher proportion of lymphoma patients will collect ≥ 2 x 10E6 CD34+ cells/kg.

Autologous stem cell transplantation (ASCT) is indicated for patients with non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL) who have primary progressive disease or who relapse after a chemotherapy-induced complete remission. For these patients, as for other patients undergoing autologous transplantation, the number of CD34+ cells collected is a reliable predictor of neutrophil and platelet (PLT) engraftment after transplantation.

AMD3100 (plerixafor) is a promising new mobilizing agent that has demonstrated efficacy in patients with NHL, HL, and multiple myeloma (MM). Although efficacious, the subcutaneous dosing of AMD3100 requires that patients receive the drug in the evening prior to apheresis, which can present logistical problems. Intravenous dosing of AMD3100 may result in a faster rise in peripheral CD34+ cell count, so that the drug can be administered the same day as apheresis. Intravenous dosing may also increase the peak CD34+ cell count, improving the number of CD34+ cells collected via apheresis.

This Phase I/II study will evaluate the safety and efficacy of intravenous AMD3100 added to the standard G-CSF mobilization regimen of patients undergoing autologous stem cell transplantation for Hodgkin and non-Hodgkin lymphomas.

Intravenous AMD3100 for Collection of Autologous Peripheral Blood Stem Cells in Patients With Lymphoma

A Phase I/II Study of Intravenous AMD3100 Added to a Mobilization Regimen of G-CSF to Increase the Number of Autologous Peripheral Blood Stem Cells Collected From Patients With Lymphoma

* MTD: the highest dose level of AMD3100 at which ≤ 1 of 6 participants experience a dose limiting toxicity (DLT). The MTD will be the Phase II dose.
* DLT: selected grade III or higher (hematologic, cardiac, pulmonary, hepatobiliary/pancreatic, renal, or CNS) not attributable to any other cause.

Dose limiting toxicity: selected grade III or higher (hematologic, cardiac, pulmonary, hepatobiliary/pancreatic, renal, or CNS) not attributable to any other cause.

Washington University School of Medicine

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Phase II

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Phase 1 (Dose Levels 1-4)

Maximum Tolerated Dose (MTD) of IV AMD3100 + G-CSF in Mobilization of Peripheral Blood Stem Cell in Patients With Lymphoma (Phase I Only)

Number of Participants Who Experienced Dose Limiting Toxicities in Phase I Portion of Study

Phase 1 and Phase 2 Participants

Kinetics of Stem Cell Mobilization Using IV AMD3100 as Measured by Median Fold Change in the Number of CD34+ Cells After AMD3100 IV Administration

Pharmacodynamic Response to a Dose of SC AMD3100 as Measured by Mean Percentage of the Circulating CD34+ Count With the 34+RA-123+/- Phenotype

Hemoglobin

Leukocytes (WBC)

Lymphopenia

Neutrophils (ANC)

Platelets

Alkaline phosphtase

SGPT (ALT)

Hypoxia

Hypotension

Mucositis

Infection with neutropenia

Febrile neutropenia

Bleeding at catheter site

Hemorrhage - spleen

Atrial fibrillation

Diarrhea

Ileus

Nausea

Vomiting

Hyperbilirubinemia

Fungal infection

Opportunistic infection

Clostridium difficile

Colitis

E. coli infection

Leptotrichia

Lung infection (pneumonia)

Staph infection

Typhlitis

Glucose - high

Magnesium - high

Potassium - low

Sodium - low

Cough

240 µg/kg SC AMD3100 Day -5

10 µg/kg SC G-CSF Day -4 thru Day -1

MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1

Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)

AMD3100

G-CSF

Apheresis

Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event

* 240 µg/kg SC AMD3100 Day -5
* 10 µg/kg SC G-CSF Day -4 thru Day -1
* 160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
* Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)

Phase I - Cohort 1

* 240 µg/kg SC AMD3100 Day -5
* 10 µg/kg SC G-CSF Day -4 thru Day -1
* 240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
* Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)

Phase I - Cohort 2

* 240 µg/kg SC AMD3100 Day -5
* 10 µg/kg SC G-CSF Day -4 thru Day -1
* 320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
* Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)

Phase I - Cohort 3

240 µg/kg SC AMD3100 Day -5 10 µg/kg SC G-CSF Day -4 thru Day -1 400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1 Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)

Phase I - Cohort 4

* 240 µg/kg SC AMD3100 Day -5
* 10 µg/kg SC G-CSF Day -4 thru Day -1
* MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1
* Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)

Phase I

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of the Best Timing for Plerixafor in Autologous Hematopoietic Stem Cell Collection	NCT01042717	Multiple Myelom... Non-Hodgkins Ly...	Plerixafor	18 Years - 75 Years	Shi, Patricia, M.D.
Etoposide+Cytarabine+PEG-rhG-CSF as First Line Mobilization Regimen of Hematopoietic Stem Cells in Patients With Hematological Malignancies	NCT05536154	Lymphoma Multiple Myelom...	Etoposide Cytarabine PEG-rhG-CSF	18 Years - 75 Years	The Affiliated People's Hospital of Ningbo University
Etoposide+Cytarabine+PEG-rhG-CSF for Hematopoietic Stem Cell Mobilization in Patients With Hematological Malignancies	NCT05510089	Hematological M...	Etoposide Cytarabine PEG-rhG-CSF	18 Years - 75 Years	The Affiliated People's Hospital of Ningbo University
Study of the Best Timing for Plerixafor in Autologous Hematopoietic Stem Cell Collection	NCT01042717	Multiple Myelom... Non-Hodgkins Ly...	Plerixafor	18 Years - 75 Years	Shi, Patricia, M.D.
Comparing Intermediate-dose CTX+ G-CSF Plus or Not rhTPO for PB CD34+ Cells Mobilization in MM Patients	NCT02572596	Multiple Myelom...	rhTPO CTX -CSF	10 Years - 70 Years	Beijing Chao Yang Hospital
Etoposide+Cytarabine+PEG-rhG-CSF for Hematopoietic Stem Cell Mobilization in Patients With Hematological Malignancies	NCT05510089	Hematological M...	Etoposide Cytarabine PEG-rhG-CSF	18 Years - 75 Years	The Affiliated People's Hospital of Ningbo University
Intravenous AMD3100 for Collection of Autologous Peripheral Blood Stem Cells in Patients With Lymphoma	NCT00733824	Lymphoma, Non-H... Hodgkin Disease	AMD3100 G-CSF Apheresis	18 Years - 75 Years	Washington University School of Medicine
Comparing Intermediate-dose CTX+ G-CSF Plus or Not rhTPO for PB CD34+ Cells Mobilization in MM Patients	NCT02572596	Multiple Myelom...	rhTPO CTX -CSF	10 Years - 70 Years	Beijing Chao Yang Hospital

Spots Global Cancer Trial Database for hematopoietic stem cell mobilization