An interventional study of plerixafor and filgrastim in Adult Acute Lymphoblastic Leukemia in Remission, Adult Grade III Lymphomatoid Granulomatosis and Adult Nasal Type Extranodal NK/T-cell Lymphoma, sponsored by Case Comprehensive Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 78 Years. Per ClinicalTrials.gov, last updated 2019-06-14.
Sponsored by Case Comprehensive Cancer Center · Not applicable, Interventional, and Treatment
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Among 144 studies in Lymphoma, Extranodal NK-T-Cell with a site in United States — 5 open to participants now, 11 under way, none of them phase 3. Lymphoma, Extranodal NK-T-Cell · United States.
Among the 144 studies in Lymphoma, Extranodal NK-T-Cell with a site in United States, this one is the 66th largest by enrollment of the 129 interventional ones that give a count, is one of 14 that started in 2011, is one of 19 with no phase, and was the 106th registered.
270 studies on the registry are indexed under Lymphoma, Extranodal NK-T-Cell; 36 are open to participants now.
Browse Lymphoma, Extranodal NK-T-Cell studies →5 of the 144 studies in Lymphoma, Extranodal NK-T-Cell with a site in United States are open now. Recruiting first, the newest first:
M.D. Anderson Cancer Center · Sites in United States
Ages 18+
Memorial Sloan Kettering Cancer Center · Sites in United States
Dren Bio · Sites in United States, Australia, France and 6 more countries
Ages 18+
UNC Lineberger Comprehensive Cancer Center · Sites in United States
Ages 65+
UNC Lineberger Comprehensive Cancer Center · Sites in United States
Ages 18–120
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 20 Lymphoma, Extranodal NK-T-Cell studies recruiting now, 11 (55%) set no upper age limit and 8 (40%) stop at 75 or younger; 4 take children under 18; 1 takes healthy volunteers.
This study: 18 Years to 78 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
144 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 70 · Phase 2 52 · Phase 3 4
First in 1988; this study’s year is marked. 14 started in 2011.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 25 is below the median of 33 across 225 interventional studies indexed under Lymphoma, Extranodal NK-T-Cell.
Median enrollment 26 across the 129 interventional studies, 45 across the 12 observational. Of the 122 that completed or were terminated, 62 (51%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 144 have an industry lead sponsor. The 10 most frequent:
Case Comprehensive Cancer Center is the lead sponsor of 495 studies on the registry; 60 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
Case Comprehensive Cancer Center has 7 studies filed under Lymphoma, Extranodal NK-T-Cell — fewer than ten, so there is no comparison to draw.
2 of the studies in Lymphoma, Extranodal NK-T-Cell with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05475925Dren BioA Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas | 2026-12 |
| NCT04288726Baylor College of MedicineAllogeneic CD30.CAR-EBVSTs in Patients With Relapsed or Refractory CD30-Positive Lymphomas | 2027-06-01 |
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Among the 144 studies in Lymphoma, Extranodal NK-T-Cell with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This clinical trial studies etoposide, filgrastim and plerixafor in improving stem cell mobilization in patients with non-Hodgkin lymphoma. Giving colony-stimulating factors, such as filgrastim, and plerixafor and etoposide together helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored.
PRIMARY OBJECTIVES:
I. To determine whether the addition of plerixafor improves the proportion of patients with lymphoma who collect >= 8 x 10\^6 cluster of differentiation (CD)34+ cells/kg within two days by 25% compared to the historical estimate of 42% with etoposide and G-CSF (filgrastim).
II. To determine whether patients achieving collection of >= 8 x 10\^6 CD34+ cells/kg have a 15% one year survival advantage relative to the historical estimate of 68% among patients mobilizing >= 2 but \< 8 x 10\^6 CD34+ cells/kg with etoposide and G-CSF.
SECONDARY OBJECTIVES:
I. To demonstrate that patients receiving >= 8 x 10\^6 CD34+ cells/kg have more rapid neutrophil and platelet recovery and earlier hospital discharge than those receiving \< 8 x 10\^6 CD 34+ cells/kg.
II. To compare overall survival and progression-free survival between patients receiving >= 8 x 10\^6 CD34+ cells/kg and those receiving \< 8 x 10\^6 CD34+ cells/kg.
III. To compare number of days of apheresis required to achieve goal, transfusion requirements, hospitalization costs, need for remobilization between groups.
IV. To evaluate whether peripheral CD34+ cell count correlates with graft content of CD34+ cells.
OUTLINE:
Patients receive etoposide intravenously (IV) over 4 hours on day 0, filgrastim subcutaneously (SC) once daily (QD) beginning day 1, and plerixafor SC 15-18 hours prior to apheresis. Patients unable to achieve target collection of >= 8 x 10\^6 CD34+ cells/kg receive another dose of plerixafor followed by apheresis. Following the second apheresis, patients achieving =\< 2 x 10\^6 CD34+ cells/kg may continue filgrastim with plerixafor and continue collection according to the attending physician.
After completion of study treatment, patients are followed up at 28 days and then for at least 1 year.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
prior to the start of mobilization, subjects must have:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive etoposide IV over 4 hours on day 0, filgrastim SC QD beginning day 1, and plerixafor SC 15-18 hours prior to apheresis. Patients unable to achieve target collection of \>= 8 x 10\^6 CD34+ cells/kg receive another dose of plerixafor followed by apheresis. Following the second apheresis, patients achieving =\< 2 x 10\^6 CD34+ cells/kg may continue filgrastim with plerixafor and continue collection according to the attending physician.
Drug: plerixafor · Biological: filgrastim · Drug: etoposide · Procedure: leukapheresis
Given SC
Also known as: AMD 3100, Mozobil
Given SC
Also known as: G-CSF, Neupogen
Given IV
Also known as: EPEG, VP-16, VP-16-213
Undergo apheresis
Collection Using Plerixafor, Etoposide, and Filgrastim
Number of participants able to collect equal to or more than 8 x 10\^6 CD34+ cells/kg with addition of plerixafor to etoposide and filgrastim. These participants are defined as supermobilizers. Participants with less than 8 x 10\^6 CD34+ cells/kg are defined as normal mobilizers.
Time frame: Within 2 days of apheresis
Progression-free Survival
The number of participants of patients who receive greater than or equal to 8 x 10\^6 CD34+ cells/kg following collection with plerixafor, etoposide, and filgrastim and that have progression-free survival at one year
Time frame: Up to 1 year post-transplant
Overall Survival
Number of participants who receive greater than or equal to 8 x 10\^6 CD34+ cells/kg by 15% following collection with plerixafor, etoposide, and filgrastimstill alive at 1 yr post transplant
Time frame: Up to 1 year post-transplant
Neutrophil Recovery in Super Mobilizers and Normal Mobilizers
Neutrophil recovery in participants receiving greater than or equal to 8 and less than 8 x 10\^6 CD34+ cells/kg entered as the mean cell count of super mobilizers and normal mobilizers.
Time frame: Up to 28 days post treatment
Platelet Recovery in Super Mobilizers and Normal Mobilizers
Platelet recovery in participants receiving greater than or equal to 8 and less than 8 x 10\^6 CD34+ cells/kg.
Time frame: Up to 28 days post treatment
Length of Hospital Stay in Super Mobilizers and Normal Mobilizers
Length of hospital stay in participants receiving greater than or equal to 8 and less than 8 x 10\^6 CD34+ cells/kg.
Time frame: Up to 28 days post treatment
Progression-free Survival in Supermobilizers and Normal Mobilizers
Percentage of participants who were alive and free of progression 1 year after transplant (PFS)
Time frame: Up to 1 year post-transplant
Overall Survival in Supermobilizers and Normal Mobilizers
Percentage of participants who were alive 1 year after transplant (OS)
Time frame: Up to 1 year post-transplant
Number of Days of Apheresis Required
Number of days of apheresis required to achieve goal in supermobilizers and normal mobilizers
Time frame: Up to 28 days post treatment
Number of Transfusion Requirements
Number of transfusions (number of packed red blood cells and platelet transfusions required from day 0 to +28 post-transplant) in supermobilizers and normal mobilizers
Time frame: Up to 28 days post treatment
Need for Remobilization
Number of participants that needed remobilization in supermobilizers and normal mobilizers. Remobilization can be described as follows: The first step for patients undergoing autologous hematopoietic cell transplantation is to mobilize hematopoietic progenitor/stem cells from the bone marrow using G-CSF, plerixafor and/or chemotherapy. This is followed by collection of the cells by apheresis. If sufficient number of progenitor/stem cells cannot be mobilized and then collected by apheresis to proceed with transplantation, it is considered as "mobilization failure". For these patients, mobilization of their hematopoietic progenitor/stem cells is attempted a second time ("remobilization"). The need to do a second 'mobilization' attempt is not ideal.
Time frame: Up to 28 days post treatment
Correlation of Peripheral CD34+ Cell Count With Graft Content of CD34+ Cells
Correlation of peripheral CD34+ cell count with graft content of CD34+ cells assessed using Spearman correlation.
Time frame: Up to 28 days post treatment
| Milestone | Treatment (Stem Cell Supermobilization) |
|---|---|
| Started | 25 |
| Completed | 24 |
| Not completed | 1 |
| Withdrew: Unable to collect cells | 1 |
Number of participants able to collect equal to or more than 8 x 10\^6 CD34+ cells/kg with addition of plerixafor to etoposide and filgrastim. These participants are defined as supermobilizers. Participants with less than 8 x 10\^6 CD34+ cells/kg are defined as normal mobilizers.
| Participants | Treatment (Stem Cell Supermobilization) |
|---|---|
| Supermobilizers | 7 |
| Normal Mobilizers | 17 |
| Non mobilizers | 1 |
The number of participants of patients who receive greater than or equal to 8 x 10\^6 CD34+ cells/kg following collection with plerixafor, etoposide, and filgrastim and that have progression-free survival at one year
| Participants | Treatment (Stem Cell Supermobilization) |
|---|---|
| Progression-free Survival | 7 |
Number of participants who receive greater than or equal to 8 x 10\^6 CD34+ cells/kg by 15% following collection with plerixafor, etoposide, and filgrastimstill alive at 1 yr post transplant
| Participants | Treatment (Stem Cell Supermobilization) |
|---|---|
| Overall Survival | 7 |
Neutrophil recovery in participants receiving greater than or equal to 8 and less than 8 x 10\^6 CD34+ cells/kg entered as the mean cell count of super mobilizers and normal mobilizers.
| K/ul | Treatment (Stem Cell Supermobilization) |
|---|---|
| Supermobilizers | 10.3 ± 0.5 |
| Normal Mobilizers | 10.2 ± 0.7 |
Platelet recovery in participants receiving greater than or equal to 8 and less than 8 x 10\^6 CD34+ cells/kg.
| percentage of change | Treatment (Stem Cell Supermobilization) |
|---|---|
| Supermobilizers | 20.9 ± 6.5 |
| Normal Mobilizers | 19.8 ± 5.6 |
Length of hospital stay in participants receiving greater than or equal to 8 and less than 8 x 10\^6 CD34+ cells/kg.
| days | Treatment (Stem Cell Supermobilization) |
|---|---|
| Supermobilizers | 20.7 ± 0.5 |
| Normal Mobilizers | 22.5 ± 5.5 |
Percentage of participants who were alive and free of progression 1 year after transplant (PFS)
| percent of participants | Treatment (Stem Cell Supermobilization) |
|---|---|
| Supermobilizers | 100 |
| Normal Mobilizers | 82 |
Percentage of participants who were alive 1 year after transplant (OS)
| percent of participants | Treatment (Stem Cell Supermobilization) |
|---|---|
| Supermobilizers | 100 |
| Normal Mobilizers | 100 |
Number of days of apheresis required to achieve goal in supermobilizers and normal mobilizers
| days | Treatment (Stem Cell Supermobilization) |
|---|---|
| Supermobilizers | 1.1 ± 0.4 |
| Normal Mobilizers | 2.9 ± 1.1 |
Number of transfusions (number of packed red blood cells and platelet transfusions required from day 0 to +28 post-transplant) in supermobilizers and normal mobilizers
| transfusions | Treatment (Stem Cell Supermobilization) |
|---|---|
| Supermobilizers | 3.7 ± 2.1 |
| Normal Mobilizers | 4.4 ± 2.0 |
Number of participants that needed remobilization in supermobilizers and normal mobilizers. Remobilization can be described as follows: The first step for patients undergoing autologous hematopoietic cell transplantation is to mobilize hematopoietic progenitor/stem cells from the bone marrow using G-CSF, plerixafor and/or chemotherapy. This is followed by collection of the cells by apheresis. If sufficient number of progenitor/stem cells cannot be mobilized and then collected by apheresis to proceed with transplantation, it is considered as "mobilization failure". For these patients, mobilization of their hematopoietic progenitor/stem cells is attempted a second time ("remobilization"). The need to do a second 'mobilization' attempt is not ideal.
| Participants | Treatment (Stem Cell Supermobilization) |
|---|---|
| Supermobilizers | 0 |
| Normal Mobilizers | 0 |
Correlation of peripheral CD34+ cell count with graft content of CD34+ cells assessed using Spearman correlation.
No measurements were reported for this outcome.
Collected over Up to 1 year post-transplant. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Stem Cell Supermobilization) | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
Participants enrolled and received intervention.
| Age, Continuous(years) | Treatment (Stem Cell Supermobilization) |
|---|---|
| Mean | 62.48 ± 11.14 |
| Sex: Female, Male(Participants) | Treatment (Stem Cell Supermobilization) |
|---|---|
| Female | 4 |
| Male | 21 |
| Ethnicity (NIH/OMB)(Participants) | Treatment (Stem Cell Supermobilization) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 25 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Treatment (Stem Cell Supermobilization) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 23 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Treatment (Stem Cell Supermobilization) |
|---|---|
| United States | 25 |
The record gives a start of Oct 2011, a primary completion of May 2016 and a completion of May 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2019, 3 years 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Plerixafor · Filgrastim · Etoposide
Lymphoma, Extranodal NK-T-Cell →
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