Non-Hodgkin's LymphomaPhase 2NCT01164345
Mozobil for Autologous Stem Cell Mobilization
A Phase 2 study testing Plerixafor in people with Non-Hodgkin's Lymphoma and Hodgkin's Lymphoma, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to evaluate Plerixafor (MOZOBIL) plus recombinant human G-CSF (G-CSF) efficiency in mobilizing sufficient number of stem cells from Lymphoma (NHL and HL) patients for autologous transplantation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Stem Cell Mobilization
- What is being tested?
- Plerixafor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2010to May 2015
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible and planned for an autologous haematopoietic stem cell transplantation.
- 1.1 Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- 1.2 WBC count ≥2.5x109/L.
- 1.3 Absolute neutrophil count ≥1.5x109/L.
- 1.4 Platelet count ≥100x109/L
- 1.5 Adequate cardiac, renal, hepatic and pulmonary function sufficient to undergo apheresis and transplantation.
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- 1.6 Previously, heavily pretreated lymphoma patients or patients suspected to have a poor bone marrow stem cell reserve for at least one of the following:
- >2 lines of chemotherapy.
- Previous radiotherapy involving bone marrow
- Prior therapy with specific stem cell toxic chemotherapeutic agents
- Platelets count pre-mobilisation, ≤150.103 x mm3
- Level of circulating CD34+ ≤ 20 cells/mcL prior to apheresis on the collection day
- Patients > 60 years of age
Who cannot join
- 2.1 Lymphoma patients that did not fulfil the inclusion criteria.
- 2.2 History of any acute or chronic leukemia (including myelodysplastic syndrome.
- 2.3 Prior allogeneic or autologous transplantation.
- 2.4 Inability to tolerate stem cell harvest.
- 2.5 Peripheral venous access not possible.
- 2.6 Pregnant or nursing women.
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- 2.7 Positive serology for hepatitis B or C.
- 2.8 Acute infection (febrile, i.e. temperature > 38C) within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of GCSF.
- 2.9 HIV positive.
- 2.10 Left ventricular ejection fraction < 50%.
- 2.11 DLCO < 50%.
- 2.12 Splenectomised or splenic irradiation.
- 2.13 Psychiatric, addictive, or any disorder/disease which compromises ability to give informed consent for participation in this study.
- 2.14 Treatment with other investigational drugs within 4 weeks of enrolling in this protocol or currently enrolled in another investigational protocol during the mobilisation phase.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Plerixafor (Plerixafor AMD 3100) + Recombinant Human G-CSF (rhG-CSF) for Autologous Peripheral Blood Stem Cell Transplantation (AutoSCT) in Hard to Mobilise Patients: a Phase IIB Study
The aim of this study is to evaluate Plerixafor (MOZOBIL) plus recombinant human G-CSF (G-CSF) efficiency in mobilizing sufficient number of stem cells from Lymphoma (NHL and HL) patients for autologous transplantation.
- Conditions
- Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Stem Cell Mobilization, Autologous Stem Cell Transplantation
- Being tested
- Plerixafor
- Keywords
- non-Hodgkin's lymphoma, Hodgkin's lymphoma, stem cell mobilization, autologous stem cell transplantation
- Medical subject headings
- Lymphoma, Non-Hodgkin, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlerixaforDrug
Also called Mozobil and Neupogen
Plerixafor (mozobil) 240 mcg/kg SC will be administered in the evening, 10 hours prior to initiation of apheresis.G-CSF will be administered in the morning at 10 mcg/kg SC for 4 days prior to apheresis.
| Study group | Role | What they receive |
|---|---|---|
| MOZOBIL | Experimental | treatment with mozobil for autologous stem cell collection Receives: Drug: Plerixafor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobilisation success rate
Mobilisation success rate is defined as the mobilisation of a PBSC graft containing >2x106 CD34+ cells/kg in ≤ 4 apheresis sessions. We will evaluate the time from chemotherapy to stem cell collection,number of collections required to reach >2x106 CD34+ cells/kg, number of CD34+ cells collected and percentage of patients reaching >5x10 CD34+ cells/kg in ≤ 4 apheresis sessions.
Measured: 4 weeks
Secondary outcomes (1)
engraftment after transplantation
speed of engraftment is determined by the time until recovery of blood counts after transplantation.
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Arnon Nagler, MD, Principal investigator, Chaim Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164345
- Sponsor's protocol ID
- SHEBA-09-7481-AN-CTIL
- Status last verified
- Dec 2015
- First submitted
- 12 Jul 2010
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plerixafor (Plerixafor AMD 3100) + Recombinant Human G-CSF (rhG-CSF) for Autologous Peripheral Blood Stem Cell Transplantation (AutoSCT) in Hard to Mobilise Patients: a Phase IIB Study
- ClinicalTrials.gov ID
- NCT01164345
- Acronym / sponsor ID
- SHEBA-09-7481-AN-CTIL
- Conditions
- Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Stem Cell Mobilization, Autologous Stem Cell Transplantation
- Keywords
- non-Hodgkin's lymphoma, Hodgkin's lymphoma, stem cell mobilization, autologous stem cell transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jun 2010
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 16 Jul 2010 (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 aim of this study is to evaluate Plerixafor (MOZOBIL) plus recombinant human G-CSF (G-CSF) efficiency in mobilizing sufficient number of stem cells from Lymphoma (NHL and HL) patients for autologous transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MOZOBIL | Experimental | Drug: Plerixafortreatment with mozobil for autologous stem cell collection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients eligible and planned for an autologous haematopoietic stem cell transplantation.
- 1.1 Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- 1.2 WBC count ≥2.5x109/L.
- 1.3 Absolute neutrophil count ≥1.5x109/L.
- 1.4 Platelet count ≥100x109/L
Key exclusion criteria (14 listed)
- 2.1 Lymphoma patients that did not fulfil the inclusion criteria.
- 2.2 History of any acute or chronic leukemia (including myelodysplastic syndrome.
- 2.3 Prior allogeneic or autologous transplantation.
- 2.4 Inability to tolerate stem cell harvest.
- 2.5 Peripheral venous access not possible.
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 |
|---|---|---|
| PlerixaforAlso: Mozobil and NeupogenPlerixafor (mozobil) 240 mcg/kg SC will be administered in the evening, 10 hours prior to initiation of apheresis.G-CSF will be administered in the morning at 10 mcg/kg SC for 4 days prior to apheresis. | Drug | MOZOBIL |
Primary outcome
Mobilisation success rate
Time frame: 4 weeks
Mobilisation success rate is defined as the mobilisation of a PBSC graft containing >2x106 CD34+ cells/kg in ≤ 4 apheresis sessions. We will evaluate the time from chemotherapy to stem cell collection,number of collections required to reach >2x106 CD34+ cells/kg, number of CD34+ cells collected and percentage of patients reaching >5x10 CD34+ cells/kg in ≤ 4 apheresis sessions.
1 secondary outcome
engraftment after transplantation
Time frame: 100 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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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.
Arnon Nagler, MD principal investigator
Chaim Sheba Medical Center
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 Plerixafor in people with Non-Hodgkin's Lymphoma and Hodgkin's Lymphoma, run by Sheba Medical Center at 1 site in Israel.
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 13 inclusion and 14 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 3 Dec 2015. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mobilisation success rate (time frame: 4 weeks). 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 3 Dec 2015.