An interventional study of bortezomib and filgrastim in Adult Grade III Lymphomatoid Granulomatosis, B-cell Chronic Lymphocytic Leukemia and Contiguous Stage II Adult Burkitt Lymphoma, sponsored by Barbara Ann Karmanos Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-05-10.
Sponsored by Barbara Ann Karmanos Cancer Institute · Not applicable, Interventional, and Treatment
Among 20 studies testing bortezomib in Leukemia, Lymphocytic, Chronic, B-Cell — none open to participants now, none under way, none of them phase 3. Bortezomib · Leukemia, Lymphocytic, Chronic, B-Cell.
Among the 20 studies testing bortezomib in Leukemia, Lymphocytic, Chronic, B-Cell, this one is the 11th largest by enrollment of the 17 interventional ones that give a count, is the only one that started in 2011, is the only one with no phase, and was the 18th registered.
2,036 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 237 are open to participants now.
Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →None of the 20 studies testing bortezomib in Leukemia, Lymphocytic, Chronic, B-Cell is open now.
Bortezomib: first FDA approval 2003 (VELCADE), first EMA approval 2004. What it is approved for, and how studies give it, is on its page →
Of the 188 Leukemia, Lymphocytic, Chronic, B-Cell studies recruiting now, 150 (80%) set no upper age limit and 15 (8%) stop at 75 or younger; 17 take children under 18; 13 take healthy volunteers.
This study: 18 Years to 70 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.
20 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 13 · Phase 2 8
First in 1999; this study’s year is marked. 1 started in 2011.
This study's enrollment of 23 is below the median of 39 across 1,603 interventional studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.
Median enrollment 35 across the 17 interventional studies. Of the 19 that completed or were terminated, 6 (32%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 20 has an industry lead sponsor. The 10 most frequent:
Barbara Ann Karmanos Cancer Institute is the lead sponsor of 161 studies on the registry; 19 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
16 studies in Leukemia, Lymphocytic, Chronic, B-Cell by Barbara Ann Karmanos Cancer Institute: none open now, 1 under way, none of them phase 3. Of 13 finished, 6 (46%) have results posted.
Among the 16 studies in Leukemia, Lymphocytic, Chronic, B-Cell by Barbara Ann Karmanos Cancer Institute, this one is the 7th largest by enrollment of the 13 interventional ones that give a count, is the only one that started in 2011, is one of 4 with no phase, and was the 14th registered.
Barbara Ann Karmanos Cancer Institute’s Leukemia, Lymphocytic, Chronic, B-Cell studies by the year they started, since 1993.
None of the studies under way reaches primary completion within a year.
Among the 20 studies testing bortezomib in Leukemia, Lymphocytic, Chronic, B-Cell, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Barbara Ann Karmanos Cancer Institute’s 16 in Leukemia, Lymphocytic, Chronic, B-Cell:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This clinical trial studies peripheral blood hemapoietic stem cell mobilization with the combination of bortezomib and G-CSF (filgrastim) in multiple myeloma and non-Hodgkin lymphoma patients.
PRIMARY OBJECTIVES:
I. To estimate if addition of Bortezomib to the mobilization protocol will result with an increase in the levels of circulating peripheral blood stem cells (PBSCs) by at least 2-fold in blood and in the apheresis collections in up to 4-days collection protocol.
II. To assess whether time to neutrophil engraftment is 12 days or less, the historical value.
SECONDARY OBJECTIVES:
I. To test for co-mobilization of lymphoma or myeloma cells by bortezomib and G-CSF using real time polymerase chain reaction (PCR) for non-Hodgkin lymphoma (NHL) patients and by flow cytometry (cluster of differentiation [CD]38+/CD138+ cell) for multiple myeloma (MM) patients.
II. To determine the effect of Bortezomib on the extent of mobilization of dendritic cells subsets, plasmacytoid dendritic cell (pDC)1 and pDC2 and DC1/DC2 ratio by flow cytometry.
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.
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.
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.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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 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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
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.
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.
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.
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.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
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.
GROUP A: Bortezomib administered in the evening after comploetion of G-CSF collection or on day 6 of mobilization with G-CSF.
Drug: bortezomib · Biological: filgrastim · Procedure: autologous hematopoietic stem cell transplantation
GROUP B: Bortexomib administered on days 4 \& day 7, before administration of filgrastim.
Drug: bortezomib · Biological: filgrastim · Procedure: autologous hematopoietic stem cell transplantation
Given IV
Also known as: LDP 341, MLN341, VELCADE
Given SC
Also known as: G-CSF, Neupogen
Undergo autologous hematopoietic stem cell transplantation
>= 2 Fold Increase in Circulating PBSC's
Participants with \>= 2 fold increase in circulating PBSC's in blood and in apheresis collections in up to 4-days collection
Time frame: Up to 6 months
Time to Neutrophil Engraftment
Estimated Median Time to Neutrophil Engraftment, ANC 500
Time frame: Up to 6 months
| Milestone | A. Standard of Care Mobilization | GROUP B: Alternative Mobilization |
|---|---|---|
| Started | 3 | 20 |
| Completed | 3 | 17 |
| Not completed | 0 | 3 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Withdrawn prior to velcade | 0 | 2 |
Participants with \>= 2 fold increase in circulating PBSC's in blood and in apheresis collections in up to 4-days collection
| Participants | Group A: Bortezomib 1.3 mg/m2 | Group B Bortezomib 1/3 mg/m2 |
|---|---|---|
| Doubling | 0 | 4 |
| Less than doubling | 3 | 13 |
Estimated Median Time to Neutrophil Engraftment, ANC 500
| days to ANC 500 | Arm A Standard of Care Mobilization | Arm B Alternative Mobilization |
|---|---|---|
| Time to Neutrophil Engraftment | 12 (12 to NA) | 13 (12 to 14) |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| A Treatment (Bortezomib and Filgrastim) | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| B Treatment (Bortezomib and Filgrastim) | 0/17 (0%) | 0/17 (0%) | 17/17 (100%) |
| Event | A Treatment (Bortezomib and Filgrastim) | B Treatment (Bortezomib and Filgrastim) |
|---|---|---|
| HypocalcemiaBlood and lymphatic system disorders | 2/6 | 3/17 |
| Infection 1Infections and infestations | 1/6 | 4/17 |
| HypokalemiaBlood and lymphatic system disorders | 0/6 | 3/17 |
| Infection 2Infections and infestations | 0/6 | 3/17 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 1/6 | 0/17 |
| TachycardiaCardiac disorders | 1/6 | 0/17 |
| HyperuricemiaBlood and lymphatic system disorders | 1/6 | 0/17 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/6 | 2/17 |
| Hypertensive crisisCardiac disorders | 0/6 | 1/17 |
| MucositisImmune system disorders | 0/6 | 1/17 |
Evaluable participants
| Age, Categorical(Participants) | Arm A | Arm B | Total |
|---|---|---|---|
| g — <=18 years | 0 | 0 | 0 |
| g — Between 18 and 65 years | 2 | 13 | 15 |
| g — >=65 years | 1 | 4 | 5 |
| Age, Continuous(years) | Arm A | Arm B | Total |
|---|---|---|---|
| Median | 62 (52 to 67) | 56 (40 to 68) | 58 (40 to 68) |
| Sex: Female, Male(Participants) | Arm A | Arm B | Total |
|---|---|---|---|
| Female | 2 | 9 | 11 |
| Male | 1 | 8 | 9 |
| Race (NIH/OMB)(Participants) | Arm A | Arm B | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 3 | 4 |
| White | 2 | 14 | 16 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Arm A | Arm B | Total |
|---|---|---|---|
| United States | 3 | 17 | 20 |
The record gives a start of Jul 2011, a primary completion of Jan 2015 and a completion of Jan 2015. It does not say whether these dates are actual or estimated.
Results were first posted in May 2021, 6 years 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drugs tested here: Bortezomib · Filgrastim
Leukemia, Lymphocytic, Chronic, B-Cell →
Barbara Ann Karmanos Cancer Institute →