Hodgkin's LymphomaPhase 3NCT02722733
Randomized Trial of G-CSF Alone Versus Intermediate-dose Ara-C Plus G-CSF Mobilization in Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
A Phase 3 study testing G-CSF (filgrastim) and Cytosine arabinoside with G-CSF (filgrastim) in people with Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
Trial summary
The purpose of the study is to compare safety and efficacy of stem cell mobilization using G-CSF (filgrastim) alone vs. intermediate-dose cytosine arabinoside plus G-CSF in Hodgkin's lymphoma and non-Hodgkin's lymphoma patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
- What is being tested?
- G-CSF (filgrastim) and Cytosine arabinoside with G-CSF (filgrastim)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- Mar 2016to Apr 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hodgkin's lymphoma and non-Hodgkin's lymphoma patients considered eligible for autologous stem cell transplantation procedure.
- Must not have achieved complete remission after first line of therapy or must have relapsed lymphoma.
- Must have received at least two lines of therapy including four or more cycles.
- Must have achieved a partial (PR) or complete remission (CR) .
- Must be 18-65 years of age.
- Must have World Health Organization performance status 0-1.
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- Time from administration or discontinuation of any chemotherapy agent must be at least four weeks.
- Hemoglobin level > 8 g/dl, Absolute neutrophil count (ANC) > 1.5 x 10^9/L, Platelet count >100 x 10^9/L.
- Serum creatinine < 1.5 x upper limit of normal (ULN), serum bilirubin < 1.5 ULN, serum aspartate transaminase (AST/SGOT) < 2.5 x ULN, serum alanine transaminase (ALT/SGPT) < 2.5 x ULN.
- Negative human immunodeficiency virus (HIV) infection test.
- Negative pregnancy test.
- Must understand and voluntarily sign informed consent form.
Who cannot join
- Failure of prior, first-line mobilization regimen.
- Infiltration of central nervous system.
- Bone marrow plasma cell infiltration of above 20%.
- Administration of nitrosourea derivatives (Carmustine, Lomustine) within 4 weeks before starting study treatment.
- Administration of growth-factor other than G-CSF Administration of G-CSF within 14 days before starting study treatment.
- Ongoing or active infection.
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- Coexisting neoplasm, other than Hodgkin's or non-Hodgkin's lymphoma.
- Administration of radioimmunotherapy in past.
- Pregnant or lactating females.
- Patients treated with use of autologous or allogenic stem cell transplantation in the past.
- Positive human immunodeficiency virus (HIV) infection test.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch
Gliwice, 44-101
Sebastian Giebel, Prof MD, +48322788523, ots@gliwice.io.pl
Katarzyna Soska, MD
About this study
Official title: Safety and Efficacy of Stem Cell Mobilization Using G-CSF (Filgrastim) Alone Compared to Intermediate-dose Cytosine Arabinoside Plus G-CSF in Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma Patients.
The purpose of the study is to compare safety and efficacy of stem cell mobilization using G-CSF (filgrastim) alone vs. intermediate-dose cytosine arabinoside plus G-CSF in Hodgkin's lymphoma and non-Hodgkin's lymphoma patients.
Read the detailed description
Autologous hematopoietic stem cell transplantation (autoHSCT) is a standard treatment of eligible patients suffering from Hodgkin's Lymphoma or non-Hodgkin's Lymphoma (HL, NHL). AutoHSCT allows to further improve results of the therapy. Nowadays, 99% of the procedures are performed using peripheral blood as a source of stem cells. Hence, the crucial point is to harvest adequate number of stem cells allowing hematopoietic recovery. The number of 2 × 10^6 CD34+ cells/kg is considered the minimal level in autoHSCT. There are two main mobilization strategies being used: based on G-CSF alone or in combination with chemotherapy (cyclophosphamide (CY) at dose range 1.6 g/m2 is mainly used in HL and NHL setting). However, a proportion of patients (5-40%) fail to collect the minimum number of cells required. Novel agents, like plerixafor, CXCR4 inhibitor, may enable effective CD34+ cell harvest in "poor mobilizers". Nevertheless, the optimal first-line and cost-effective protocol for mobilization of hematopoietic stem cells has not been determined so far.
Randomized trials compare chemomobilization with the use of CY + G-CSF to G-CSF alone, which had been conducted so far, did not demonstrate clear advantage of addition of CY to the growth factor. Intermediate-dose cytosine arabinoside (AraC), 1.6 g/m2 plus filgrastim, has been shown to produce very high efficacy as a first or second-line mobilization regimen in patients with lymphoid malignancies. In a retrospective comparison, this strategy was significantly more effective than CY + G-CSF. This suggest that the type of chemotherapy agent added to G-CSF may play role in mobilization efficacy and that the combination of AraC and G-CSF may be more effective than G-CSF used alone. The goal of current study is to verify this hypothesis in randomized controlled trial.
- Conditions
- Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
- Being tested
- G-CSF (filgrastim), Cytosine arabinoside with G-CSF (filgrastim)
- Keywords
- Hodgkin's lymphoma, Non-Hodgkin's lymphoma, mobilization, G-CSF, filgrastim, cytosine arabinoside, autologous stem cell transplantation
- Medical subject headings
- Hodgkin Disease, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-CSF (filgrastim)Drug
Cytosine arabinoside with G-CSF (filgrastim)Drug
| Study group | Role | What they receive |
|---|---|---|
| G-CSF (filgrastim) | Active comparator | 1.G-CSF at 10 μg/kg per day (divided into two doses every 12 hours) subcutaneously for up to 7 days. Receives: Drug: G-CSF (filgrastim) |
| Cytosine arabinoside + G-CSF (filgrastim) | Active comparator | 1. Cytosine arabinoside will be administered as a 2-hour i.v. infusion at a dose of 0.4 g/m2 twice daily on days 1 and 2 (total dose 1.6 g/m2).
2. G-CSF 5-10 μg/kg per day (divided into two doses every 12 hours) will be started on day 5 subcutaneously and continued until last leukapheresis. Receives: Drug: Cytosine arabinoside with G-CSF (filgrastim) |
What is being measured
The primary outcome is the main question the study is designed to answer.
• The proportion of patients with stem cell yield at least 2 × 10^6 CD34+ cells/kg in each treatment arm.
Measured: After up to three leukaphereses (7-20 days after starting mobilization regimen).
Secondary outcomes (10)
Peak level of CD34+ cells in peripheral blood (cells/μl).
Measured: 7-20 days after starting mobilization regimen.
Total number of harvested CD34+cells/kg.
Measured: After up to three leukaphereses (7-20 days after starting mobilization regimen).
Number of leukaphereses needed to harvest target amount of stem cells.
Measured: 7-20 days after starting mobilization regimen.
The proportion of hematologic and non-hematologic complications.
Measured: 1 month after transplantation.
Duration of neutropenia < 0.5 x10^9/L.
Measured: 1 month after transplantation.
Number of blood transfusions needed.
Measured: 1 month after transplantation.
Duration of hospital stay.
Measured: 1 month after transplantation.
Time of neutrophil and platelet engraftment after autologous stem cel transplantation.
Measured: 1 month after transplantation.
Duration of thrombocytopenia <50 x 10 ^9/L.
Measured: 1 month after transplantation.
Number of days of antibiotics therapy.
Measured: 1 month after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Giebel, Maria Sklodowska-Curie National Research Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722733
- Sponsor's protocol ID
- HL/NHLMobil-COI-01
- Status last verified
- Mar 2016
- First submitted
- 11 Mar 2016
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Narayanasami U, Kanteti R, Morelli J, Klekar A, Al-Olama A, Keating C, O'Connor C, Berkman E, Erban JK, Sprague KA, Miller KB, Schenkein DP. Randomized trial of filgrastim versus chemotherapy and filgrastim mobilization of hematopoietic progenitor cells for rescue in autologous transplantation. Blood. 2001 Oct 1;98(7):2059-64. doi: 10.1182/blood.v98.7.2059.
PubMed 11567990Karanth M, Chakrabarti S, Lovell RA, Harvey C, Holder K, McConkey CC, McDonald D, Fegan CD, Milligan DW. A randomised study comparing peripheral blood progenitor mobilisation using intermediate-dose cyclophosphamide plus lenograstim with lenograstim alone. Bone Marrow Transplant. 2004 Sep;34(5):399-403. doi: 10.1038/sj.bmt.1704598.
PubMed 15273706Sheppard D, Bredeson C, Allan D, Tay J. Systematic review of randomized controlled trials of hematopoietic stem cell mobilization strategies for autologous transplantation for hematologic malignancies. Biol Blood Marrow Transplant. 2012 Aug;18(8):1191-203. doi: 10.1016/j.bbmt.2012.01.008. Epub 2012 Jan 16.
PubMed 22261379Kruzel T, Sadus-Wojciechowska M, Najda J, Czerw T, Glowala-Kosinska M, Holowiecki J, Giebel S. Very high efficacy of intermediate-dose cytarabine in combination with G-CSF as a second-line mobilization of hematopoietic stem cells. Int J Hematol. 2012 Aug;96(2):287-9. doi: 10.1007/s12185-012-1135-5. Epub 2012 Jul 14. No abstract available.
PubMed 22797877Giebel S, Kruzel T, Czerw T, Sadus-Wojciechowska M, Najda J, Chmielowska E, Grosicki S, Jurczyszyn A, Pasiarski M, Nowara E, Glowala-Kosinka M, Chwieduk A, Mitrus I, Smagur A, Holowiecki J. Intermediate-dose Ara-C plus G-CSF for stem cell mobilization in patients with lymphoid malignancies, including predicted poor mobilizers. Bone Marrow Transplant. 2013 Jul;48(7):915-21. doi: 10.1038/bmt.2012.269. Epub 2013 Jan 7.
PubMed 23292239
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Stem Cell Mobilization Using G-CSF (Filgrastim) Alone Compared to Intermediate-dose Cytosine Arabinoside Plus G-CSF in Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma Patients.
- ClinicalTrials.gov ID
- NCT02722733
- Acronym / sponsor ID
- HL/NHLMobil-COI-01
- Conditions
- Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
- Keywords
- Hodgkin's lymphoma, Non-Hodgkin's lymphoma, mobilization, G-CSF, filgrastim, cytosine arabinoside, autologous stem cell transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare safety and efficacy of stem cell mobilization using G-CSF (filgrastim) alone vs. intermediate-dose cytosine arabinoside plus G-CSF in Hodgkin's lymphoma and non-Hodgkin's lymphoma patients.
Detailed description
Autologous hematopoietic stem cell transplantation (autoHSCT) is a standard treatment of eligible patients suffering from Hodgkin's Lymphoma or non-Hodgkin's Lymphoma (HL, NHL). AutoHSCT allows to further improve results of the therapy. Nowadays, 99% of the procedures are performed using peripheral blood as a source of stem cells. Hence, the crucial point is to harvest adequate number of stem cells allowing hematopoietic recovery. The number of 2 × 10^6 CD34+ cells/kg is considered the minimal level in autoHSCT. There are two main mobilization strategies being used: based on G-CSF alone or in combination with chemotherapy (cyclophosphamide (CY) at dose range 1.6 g/m2 is mainly used in HL and NHL setting). However, a proportion of patients (5-40%) fail to collect the minimum number of cells required. Novel agents, like plerixafor, CXCR4 inhibitor, may enable effective CD34+ cell harvest in "poor mobilizers". Nevertheless, the optimal first-line and cost-effective protocol for mobilization of hematopoietic stem cells has not been determined so far.
Randomized trials compare chemomobilization with the use of CY + G-CSF to G-CSF alone, which had been conducted so far, did not demonstrate clear advantage of addition of CY to the growth factor. Intermediate-dose cytosine arabinoside (AraC), 1.6 g/m2 plus filgrastim, has been shown to produce very high efficacy as a first or second-line mobilization regimen in patients with lymphoid malignancies. In a retrospective comparison, this strategy was significantly more effective than CY + G-CSF. This suggest that the type of chemotherapy agent added to G-CSF may play role in mobilization efficacy and that the combination of AraC and G-CSF may be more effective than G-CSF used alone. The goal of current study is to verify this hypothesis in randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-CSF (filgrastim) | Active comparator | Drug: G-CSF (filgrastim)1.G-CSF at 10 μg/kg per day (divided into two doses every 12 hours) subcutaneously for up to 7 days. |
| Cytosine arabinoside + G-CSF (filgrastim) | Active comparator | Drug: Cytosine arabinoside with G-CSF (filgrastim)1. Cytosine arabinoside will be administered as a 2-hour i.v. infusion at a dose of 0.4 g/m2 twice daily on days 1 and 2 (total dose 1.6 g/m2). 2. G-CSF 5-10 μg/kg per day (divided into two doses every 12 hours) will be started on day 5 subcutaneously and continued until last leukapheresis. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Hodgkin's lymphoma and non-Hodgkin's lymphoma patients considered eligible for autologous stem cell transplantation procedure.
- Must not have achieved complete remission after first line of therapy or must have relapsed lymphoma.
- Must have received at least two lines of therapy including four or more cycles.
- Must have achieved a partial (PR) or complete remission (CR) .
- Must be 18-65 years of age.
Key exclusion criteria (11 listed)
- Failure of prior, first-line mobilization regimen.
- Infiltration of central nervous system.
- Bone marrow plasma cell infiltration of above 20%.
- Administration of nitrosourea derivatives (Carmustine, Lomustine) within 4 weeks before starting study treatment.
- Administration of growth-factor other than G-CSF Administration of G-CSF within 14 days before starting study 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 |
|---|---|---|
| G-CSF (filgrastim) | Drug | G-CSF (filgrastim) |
| Cytosine arabinoside with G-CSF (filgrastim) | Drug | Cytosine arabinoside + G-CSF (filgrastim) |
Primary outcome
• The proportion of patients with stem cell yield at least 2 × 10^6 CD34+ cells/kg in each treatment arm.
Time frame: After up to three leukaphereses (7-20 days after starting mobilization regimen).
10 secondary outcomes
Peak level of CD34+ cells in peripheral blood (cells/μl).
Time frame: 7-20 days after starting mobilization regimen.
Total number of harvested CD34+cells/kg.
Time frame: After up to three leukaphereses (7-20 days after starting mobilization regimen).
Number of leukaphereses needed to harvest target amount of stem cells.
Time frame: 7-20 days after starting mobilization regimen.
The proportion of hematologic and non-hematologic complications.
Time frame: 1 month after transplantation.
Duration of neutropenia < 0.5 x10^9/L.
Time frame: 1 month after transplantation.
Number of blood transfusions needed.
Time frame: 1 month after transplantation.
Duration of hospital stay.
Time frame: 1 month after transplantation.
Time of neutrophil and platelet engraftment after autologous stem cel transplantation.
Time frame: 1 month after transplantation.
Duration of thrombocytopenia <50 x 10 ^9/L.
Time frame: 1 month after transplantation.
Number of days of antibiotics therapy.
Time frame: 1 month after transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
- Background: PubMed 11567990Narayanasami U, Kanteti R, Morelli J, Klekar A, Al-Olama A, Keating C, O'Connor C, Berkman E, Erban JK, Sprague KA, Miller KB, Schenkein DP. Randomized trial of filgrastim versus chemotherapy and filgrastim mobilization of hematopoietic progenitor cells for rescue in autologous transplantation. Blood. 2001 Oct 1;98(7):2059-64. doi: 10.1182/blood.v98.7.2059.
- Background: PubMed 15273706Karanth M, Chakrabarti S, Lovell RA, Harvey C, Holder K, McConkey CC, McDonald D, Fegan CD, Milligan DW. A randomised study comparing peripheral blood progenitor mobilisation using intermediate-dose cyclophosphamide plus lenograstim with lenograstim alone. Bone Marrow Transplant. 2004 Sep;34(5):399-403. doi: 10.1038/sj.bmt.1704598.
- Background: PubMed 22261379Sheppard D, Bredeson C, Allan D, Tay J. Systematic review of randomized controlled trials of hematopoietic stem cell mobilization strategies for autologous transplantation for hematologic malignancies. Biol Blood Marrow Transplant. 2012 Aug;18(8):1191-203. doi: 10.1016/j.bbmt.2012.01.008. Epub 2012 Jan 16.
- Background: PubMed 22797877Kruzel T, Sadus-Wojciechowska M, Najda J, Czerw T, Glowala-Kosinska M, Holowiecki J, Giebel S. Very high efficacy of intermediate-dose cytarabine in combination with G-CSF as a second-line mobilization of hematopoietic stem cells. Int J Hematol. 2012 Aug;96(2):287-9. doi: 10.1007/s12185-012-1135-5. Epub 2012 Jul 14. No abstract available.
- Background: PubMed 23292239Giebel S, Kruzel T, Czerw T, Sadus-Wojciechowska M, Najda J, Chmielowska E, Grosicki S, Jurczyszyn A, Pasiarski M, Nowara E, Glowala-Kosinka M, Chwieduk A, Mitrus I, Smagur A, Holowiecki J. Intermediate-dose Ara-C plus G-CSF for stem cell mobilization in patients with lymphoid malignancies, including predicted poor mobilizers. Bone Marrow Transplant. 2013 Jul;48(7):915-21. doi: 10.1038/bmt.2012.269. Epub 2013 Jan 7.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing G-CSF (filgrastim) and Cytosine arabinoside with G-CSF (filgrastim) in people with Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
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 12 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 30 Mar 2016. 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 Poland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katarzyna Soska, MD (+48322788520, katarzyna.soska@io.gliwice.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• The proportion of patients with stem cell yield at least 2 × 10^6 CD34+ cells/kg in each treatment arm. (time frame: After up to three leukaphereses (7-20 days after starting mobilization regimen).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02722733, which also lists 5 linked publications.
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 30 Mar 2016.