Non-Hodgkin's LymphomaPhase 2NCT03317899
Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma
A Phase 2 study testing Hematopoietic Cell Transplantation, Tbo-filgrastim and Laboratory Biomarker Analysis in people with Non-Hodgkin's Lymphoma and Plasma Cell Myeloma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
This phase II trial studies how well stem cell transplant with or without tbo-filgrastim works in treating patients with multiple myeloma or non-Hodgkin lymphoma. Eliminating the use of tbo-filgrastim after transplant may still help maintain a similar time to discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Plasma Cell Myeloma
- What is being tested?
- Hematopoietic Cell Transplantation, Tbo-filgrastim and Laboratory Biomarker Analysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2017to 16 Nov 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing autologous stem cell transplant for one of the following diagnoses:
- Multiple myeloma
- Non-Hodgkin lymphoma
- Karnofsky performance status of >= 70%
- Patients must meet the Thomas Jefferson University Hospital (TJUH) bone marrow transplant (BMT) standard of procedure (SOP) guidelines for "Patient Criteria for Autologous HSCT"
- Left ventricular ejection fraction (LVEF) of ≥ 40%
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- Adjusted Carbon monoxide diffusing capability (DLCO) > 45% of predicted corrected for hemoglobin
- Serum bilirubin < 1.8
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 X upper limit of normal
- Serum creatinine =< 2.0 mg/dl and/or creatinine clearance of > 40 ml/min (excludes multiple myeloma patients receiving high dose melphalan conditioning)
- Willingness to use contraception if childbearing potential
- Has the ability to give informed consent, or for cognitively or decisionally impaired individuals (vulnerable population), the availability of a family member or guardian to give consent and assist in the consent process
- Life expectancy of > 12 months (exclusive of the disease for which the auto HSCT is being performed)
- Patients must have undergone stem cell mobilization with the combination of G-CSF and plerixafor as per TJUH BMT SOP guidelines
- Collection of an adequate number of CD34+ stem cells, i.e. >= 4-6 x 10^6/kg from apheresis
Who cannot join
- Uncontrolled human immunodeficiency virus (HIV)
- Uncontrolled bacterial infection
- Active central nervous system (CNS) disease
- Pregnancy or lactation
- Evidence of another malignancy, exclusive of a skin cancer that requires only local treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Randomized Controlled Trial Evaluating the Use of G-CSF After Plerixafor-Mobilized Autologous Stem Cell Transplant (Auto HSCT)
This phase II trial studies how well stem cell transplant with or without tbo-filgrastim works in treating patients with multiple myeloma or non-Hodgkin lymphoma. Eliminating the use of tbo-filgrastim after transplant may still help maintain a similar time to discharge.
Read the detailed description
PRIMARY OBJECTIVE:
- To demonstrate non-inferiority in the number of days to discharge readiness after a granulocyte colony-stimulating factor (G-CSF) + plerixafor-mobilized autologous stem cell transplant in patients receiving versus not receiving post-transplant growth factor support.
SECONDARY OBJECTIVE:
- To compare days to absolute neutrophil count (ANC) > 500, days to platelet engraftment, febrile days, days of febrile neutropenia, documented infections, and number of antibiotic days in patients receiving versus not receiving post-transplant growth factor support.
EXPLORATORY OBJECTIVE:
- To evaluate immunological recovery (lymphocyte number including CD 3/4 and CD3/8 T cell subsets) at day + 60 in patients receiving versus not receiving post-transplant growth factor support.
- Conditions
- Non-Hodgkin's Lymphoma, Plasma Cell Myeloma
- Being tested
- Hematopoietic Cell Transplantation, Tbo-filgrastim, Laboratory Biomarker Analysis
- Medical subject headings
- Lymphoma, Non-Hodgkin, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hematopoietic Cell TransplantationProcedure or surgery
Undergo auto HSCT
Tbo-filgrastimDrug
Also called Filgrastim Biosimilar Tbo-filgrastim, Filgrastim XM02, Granix
Given subcutaneously
Laboratory Biomarker AnalysisOther
Correlative Studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (auto HSCT tbo-filgrastim) | Experimental | Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days. Receives: Procedure: Hematopoietic Cell Transplantation; Drug: Tbo-filgrastim; Other: Laboratory Biomarker Analysis |
| Group II (auto HSCT) | Experimental | Patients undergo auto Hematopoietic Cell Transplantation (HSCT). Receives: Procedure: Hematopoietic Cell Transplantation; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days to Discharge
Will compare days to discharge readiness between the two groups.
Measured: Up to 60 days
Secondary outcomes (9)
Median Days Post Autologous Hematopoietic Cell Transplantation (Auto HSCT) to Neutrophil Engraftment
Will be defined as absolute neutrophil count > 500 x 10^9/L x 3 days. Day of engraftment is the first of the 3 days of absolute neutrophil count > 500 x 10^9/L.
Measured: Up to 60 days
Median Days Post Auto HSCT to Platelet Engraftment
Will be defined as date platelet greater than or equal to 20 x 10^9 /L without a platelet transfusion within the last 7 days.
Measured: Up to 60 days
Percentage of Participants With Engraftment Syndrome
Will be defined by the Maiolino Criteria. Will be summarized by treatment arm and compared using a chi-square test
Measured: Up to 60 days
Median Number of Febrile Days During the Auto HSCT Inpatient Stay
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests
Measured: Up to 60 days
Median Number of Days of Febrile Neutropenia During the Auto HSCT Inpatient Stay
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.
Measured: Up to 60 days
Median Number of Documented Infections Treatment During the Auto HSCT Inpatient Stay
Will be defined as a positive blood culture not ultimately deemed to be due to a contaminant
Measured: Up to 60 days
Median Number of Antibiotic Days During the Auto HSCT Inpatient Stay
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.
Measured: Up to 60 days
Percentage of Participants Receiving Corticosteroids
will be presented as percentage of number of subjects who had the treatment
Measured: Up to 60 days
Percentage of Participants With Post Discharge Granulocyte Colony-stimulating Factor Administrations Through Day +60 Post Auto HSCT
will be presented as percentage of number of subjects who had the treatment
Measured: Up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start12 Oct 2017
- Primary completion1 Jun 2021
- Study completion16 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dolores Grosso, DNP, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317899
- Sponsor's protocol ID
- 17D.404
- Other IDs
- JT 10928
- Status last verified
- Sep 2025
- First submitted
- 18 Oct 2017
- Last updated
- 17 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating the Use of G-CSF After Plerixafor-Mobilized Autologous Stem Cell Transplant (Auto HSCT)
- ClinicalTrials.gov ID
- NCT03317899
- Acronym / sponsor ID
- 17D.404
- Conditions
- Non-Hodgkin's Lymphoma, Plasma Cell Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 16 Nov 2022 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Posted 17 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well stem cell transplant with or without tbo-filgrastim works in treating patients with multiple myeloma or non-Hodgkin lymphoma. Eliminating the use of tbo-filgrastim after transplant may still help maintain a similar time to discharge.
Detailed description
PRIMARY OBJECTIVE:
- To demonstrate non-inferiority in the number of days to discharge readiness after a granulocyte colony-stimulating factor (G-CSF) + plerixafor-mobilized autologous stem cell transplant in patients receiving versus not receiving post-transplant growth factor support.
SECONDARY OBJECTIVE:
- To compare days to absolute neutrophil count (ANC) > 500, days to platelet engraftment, febrile days, days of febrile neutropenia, documented infections, and number of antibiotic days in patients receiving versus not receiving post-transplant growth factor support.
EXPLORATORY OBJECTIVE:
- To evaluate immunological recovery (lymphocyte number including CD 3/4 and CD3/8 T cell subsets) at day + 60 in patients receiving versus not receiving post-transplant growth factor support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (auto HSCT tbo-filgrastim) | Experimental | Procedure: Hematopoietic Cell Transplantation, Drug: Tbo-filgrastim, Other: Laboratory Biomarker AnalysisBeginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days. |
| Group II (auto HSCT) | Experimental | Procedure: Hematopoietic Cell Transplantation, Other: Laboratory Biomarker AnalysisPatients undergo auto Hematopoietic Cell Transplantation (HSCT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Undergoing autologous stem cell transplant for one of the following diagnoses:
- Karnofsky performance status of >= 70%
- Patients must meet the Thomas Jefferson University Hospital (TJUH) bone marrow transplant (BMT) standard of procedure (SOP) guidelines for "Patient Criteria for Autologous HSCT"
- Left ventricular ejection fraction (LVEF) of ≥ 40%
- Adjusted Carbon monoxide diffusing capability (DLCO) > 45% of predicted corrected for hemoglobin
Key exclusion criteria (5 listed)
- Uncontrolled human immunodeficiency virus (HIV)
- Uncontrolled bacterial infection
- Active central nervous system (CNS) disease
- Pregnancy or lactation
- Evidence of another malignancy, exclusive of a skin cancer that requires only local treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hematopoietic Cell TransplantationUndergo auto HSCT | Procedure or surgery | Group I (auto HSCT tbo-filgrastim), Group II (auto HSCT) |
| Tbo-filgrastimAlso: Filgrastim Biosimilar Tbo-filgrastim, Filgrastim XM02, GranixGiven subcutaneously | Drug | Group I (auto HSCT tbo-filgrastim) |
| Laboratory Biomarker AnalysisCorrelative Studies | Other | Group I (auto HSCT tbo-filgrastim), Group II (auto HSCT) |
Primary outcome
Number of Days to Discharge
Time frame: Up to 60 days
Will compare days to discharge readiness between the two groups.
9 secondary outcomes
Median Days Post Autologous Hematopoietic Cell Transplantation (Auto HSCT) to Neutrophil Engraftment
Time frame: Up to 60 days
Median Days Post Auto HSCT to Platelet Engraftment
Time frame: Up to 60 days
Percentage of Participants With Engraftment Syndrome
Time frame: Up to 60 days
Median Number of Febrile Days During the Auto HSCT Inpatient Stay
Time frame: Up to 60 days
Median Number of Days of Febrile Neutropenia During the Auto HSCT Inpatient Stay
Time frame: Up to 60 days
Median Number of Documented Infections Treatment During the Auto HSCT Inpatient Stay
Time frame: Up to 60 days
Median Number of Antibiotic Days During the Auto HSCT Inpatient Stay
Time frame: Up to 60 days
Percentage of Participants Receiving Corticosteroids
Time frame: Up to 60 days
Percentage of Participants With Post Discharge Granulocyte Colony-stimulating Factor Administrations Through Day +60 Post Auto HSCT
Time frame: Up to 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Sidney Kimmel Cancer CenterLink provided by the sponsor.
- Thomas Jefferson University HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dolores Grosso, DNP principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hematopoietic Cell Transplantation, Tbo-filgrastim and Laboratory Biomarker Analysis in people with Non-Hodgkin's Lymphoma and Plasma Cell Myeloma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Days to Discharge (time frame: Up to 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.