Adult Grade III Lymphomatoid GranulomatosisNCT02037256

Bortezomib and Filgrastim to Promote Stem Cell Mobilization in Patients With Non-Hodgkin Lymphoma or Multiple Myeloma

A study testing bortezomib, filgrastim and autologous hematopoietic stem cell transplantation in people with Adult Grade III Lymphomatoid Granulomatosis and B-cell Chronic Lymphocytic Leukemia, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Adult Grade III Lymphomatoid Granulomatosis, B-cell Chronic Lymphocytic Leukemia, Contiguous Stage II Adult Burkitt Lymphoma
What is being tested?: bortezomib, filgrastim and autologous hematopoietic stem cell transplantation
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: Jul 2011to 21 Jan 2015
Phase: Interventional

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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Voluntary written informed consent form before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Diagnosis of B-type NHL or with multiple myeloma and eligible for autologous transplantation
No more than 3 prior regimens of chemotherapy (Rituximab is not considered chemotherapy) and 4 weeks out of Bortezomib treatment for MM
Karnofsky performance status of > 50%
The patient has recovered from all acute toxic effects of prior chemotherapy
White blood cell (WBC) > 3.0 x 10^9/L

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Absolute neutrophil count > 1.5 x 10^9/L
Platelet count > 100 x 10^9/L
Serum creatinine =< 2.2
Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvate transaminase (SGPT) less than two times the upper limit of normal (ULN)
Total bilirubin less than two times the ULN
Left ventricle ejection fraction > 50% (by normal echocardiogram [ECHO] or multi gated acquisition scan [MUGA] scan)
Diffusing capacity of the lung for carbon monoxide (DLCO) > 50%
Forced vital capacity > 50% of predicted
Negative for human immunodeficiency virus (HIV)
Female subject is either post-menopausal for at least 1 year before the screening visit, is surgically sterilized or if they are of childbearing potential , agree to use 2 effective methods of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) from the time of signing the informed consent form through 30 days after the last dose of Bortezomib, or agree to completely abstain from heterosexual intercourse; women of child bearing potential agree to use an approved form of contraception; male subject, even if surgically sterilized (i.e., status post-vasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse for the duration of the study

Who cannot join

Patient has a platelet count of < 100x 10^9/L within 14 days before enrollment
Patient has an absolute neutrophil count of ANC <1.5 x 10^9/L within 14 days before enrollment
Patient has creatinine of > 2.2 MG/DL within 14 days before enrollment
Patient has > 1.5 x ULN total bilirubin
Patient has >= grade 2 peripheral neuropathy within 14 days before enrollment
Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; prior to study entry, any electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant

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Patient has hypersensitivity to Bortezomib, boron or mannitol
Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (b-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
Participation in clinical trials with other investigational drugs not included in this trial, within 14 days before enrollment and throughout the duration of this trial
Serious medical or psychiatric illness likely to interfere with participation in this clinical study
A co-morbid condition which, in the view of the investigators, renders the patient at high risk for this study
An acute medical condition resulting from prior chemotherapy
Brain metastases or carcinomatous meningitis
Acute infection
Fever (temp > 38 degrees Celsius [C]/100.4 degrees Fahrenheit [F])
Patients of child-bearing potential unwilling to implement adequate birth control
Patients who have deterioration of their clinical status or laboratory parameters between the time of enrollment and transplant (such that they no longer meet entry criteria) may be removed from study at the discretion of the treating physician or principal investigator
Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
Radiation therapy within 3 weeks before randomization; enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201

Other trials in United States

About this study

Official title: A Pilot Study of Peripheral Blood Hematopoietic Stem Cell Mobilization With the Combination of Bortezomib and G-CSF in Multiple Myeloma and Non-Hodgkin's Lymphoma Patients

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.

Read the detailed description

PRIMARY OBJECTIVES:

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:

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.

Conditions: Adult Grade III Lymphomatoid Granulomatosis, B-cell Chronic Lymphocytic Leukemia, Contiguous Stage II Adult Burkitt Lymphoma, Contiguous Stage II Adult Diffuse Large Cell Lymphoma, Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma, Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
Being tested: bortezomib, filgrastim, autologous hematopoietic stem cell transplantation
Medical subject headings: Leukemia, Lymphocytic, Chronic, B-Cell, Intraocular Lymphoma, Lymphoma, B-Cell, Marginal Zone, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Immunoblastic, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

bortezomibDrug
Also called LDP 341, MLN341, VELCADE
Given IV
filgrastimBiological
Also called G-CSF, Neupogen
Given SC
autologous hematopoietic stem cell transplantationProcedure or surgery
Undergo autologous hematopoietic stem cell transplantation

Study groups in NCT02037256
Study group	Role	What they receive
A Treatment (bortezomib and filgrastim)	Experimental	GROUP A: Bortezomib administered in the evening after comploetion of G-CSF collection or on day 6 of mobilization with G-CSF. Receives: Drug: bortezomib; Biological: filgrastim; Procedure: autologous hematopoietic stem cell transplantation
B Treatment (bortezomib and filgrastim)	Experimental	GROUP B: Bortexomib administered on days 4 \& day 7, before administration of filgrastim. Receives: Drug: bortezomib; Biological: filgrastim; Procedure: autologous hematopoietic stem cell transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

>= 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
Measured: Up to 6 months

Secondary outcomes (1)

Time to Neutrophil Engraftment
Estimated Median Time to Neutrophil Engraftment, ANC 500
Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 201121 Jan 2015

First posted15 Jan 2014 (estimated)
Study startJul 2011
Primary completion21 Jan 2015
Study completion21 Jan 2015

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 Adult Grade III Lymphomatoid GranulomatosisStudies 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 N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02037256
Sponsor's protocol ID: 2008-134
Other IDs: NCI-2012-01173, 2008-134, P30CA022453
Status last verified: Apr 2021
First submitted: 14 Jan 2014
Last updated: 10 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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