Malignant LymphomaPhase 2SCF980266NCT01016795
Stem Cell Factor (SCF) Priming of Haematopoietic Stem Cell Grafts in Malignant Lymphoma
A Phase 2 study testing r-metHuSCF and Filgrastim and Chemotherapy plus Filgrastim in people with Malignant Lymphoma, run by Aalborg University Hospital at 8 sites in 4 countries.
Trial summary
Clinical Hypothesis: It is expected that by removing chemotherapy and adding ancestim to the mobilization scheme in most of the subjects sufficient PBPC will be harvested with a minimum of toxicity and side effects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Malignant Lymphoma
- What is being tested?
- r-metHuSCF and Filgrastim and Chemotherapy plus Filgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Jan 1999to Nov 2009
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with Hodgkin's disease and non-Hodgkin lymphomas (Real classification)
- in relapse
- refractory to initial chemotherapy
- with partial response after initial therapy
- Age > 18 years and < 65 years
- ECOG performance status 0, 1 or 2
Show all 10Show fewer
- Life expectancy of > 6 months with treatment
- ANC > or equal to 1.5 x 109/L, Platelets > or equal to 100 x 109/L
- Serum creatinine < or equal to 150 µmol/L, bilirubin, aspartate aminotransferase (ASAT), and alanine aminotransferase (ALAT) less than twice the upper limit defined at the investigating laboratory
- Prior to mobilization chemotherapy subject has given written informed consent, personally dated
Who cannot join
- Prior DexaBEAM or miniBEAM therapy and prior bone marrow or PBPC transplant
- Any history of seasonal or recurrent asthma within the preceding 10 years.
- Any history of anaphylactic / anaphylactoid-type event manifested by disseminated urticaria, laryngeal oedema, and / or bronchospasm (example, food, insect bites, etc.). Subjects with drug allergies, manifested solely by rash and / or urticaria, are not excluded
- Any history of angioedema or recurrent urticaria
- Clinical or microbiological evidence of infection at the date of enrollment.
- Subjects with a concurrent malignancy
Show all 13Show fewer
- Significant non-malignant disease including documented HIV infection, uncontrolled hypertension, unstable angina, congestive heart failure, poorly controlled diabetes, coronary angioplasty within six months, myocardial infarction within the last six months, or uncontrolled atrial or ventricular cardiac arrhythmias
- Pregnant or breast feeding subjects or those of child-bearing potential who are not using adequate contraceptive precautions
- Concurrent enrollment on any other protocol using an investigational drug
- Haematopoietic growth factors administered within one week of study entry
- Subjects with a psychiatric, addictive or any disorder which compromises ability to give truly informed consent for participation in this study
- Known sensitivity to E. coli derived products
- Concurrent use of beta adrenergic blocking agents
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Denmark3 sites
Aalborg Hospital
Aalborg, 9000
Rigshospitalet
Copenhagen, 2100
Herlev University Hospital
Copenhagen
Finland2 sites
University Hospital Helsinki
Helsinki
University Hospital Turku
Turku
Sweden2 sites
University Hospital Linköping
Linköping
University Hospital Umeå
Umeå
About this study
Official title: A Randomized Study of Peripheral Blood Progenitor Cell Priming Comparing a Combination of r-metHuSCF and Filgrastim or Chemotherapy and Filgrastim on Mobilization and Engraftment in Patients With Relapsed or Refractory Lymphomas
Clinical Hypothesis:
It is expected that by removing chemotherapy and adding ancestim to the mobilization scheme in most of the subjects sufficient PBPC will be harvested with a minimum of toxicity and side effects.
Read the detailed description
Autologous stem cell transplantation is used to support high dose chemotherapy in haematological malignancies.1-2 Peripheral blood progenitor cells (PBPC) have replaced bone marrow cells as the preferred source for transplantation due to faster blood cell recovery.3-4 One variable of major impact for posttransplant care is the number of PBPC harvested.5-8 Therefore, several clinical studies have aimed to identify priming regimens that improve progenitor and stem cell mobilizations and collections without increased toxicity. Frequently, Filgrastim (r-met HuG-CSF) is administrated alone; however, Filgrastim combined with chemotherapy has proven more effective in context of CD34+ cell numbers harvested9-11 and this combination is considered the gold standard for priming and stem cell mobilization in relapsed malignant lymphoma.
Stem cell factor (SCF) is a glycoprotein growth factor that acts on haematopoietic blood cell progenitors.12 Whereas SCF alone exerts little colony-stimulating activity on normal human bone marrow cells in vitro, combination of SCF with other recombinant haematopoietic cytokines results in a synergistic increase in numbers of colonies.13 In vivo, the addition of SCF to G-CSF (Filgrastim) synergistically increases PBPC mobilization compared to Filgrastim alone.14-17 Several clinical trials have reported the ability of the combination of SCF with Filgrastim to mobilize PBPC in patients with lymphoma, multiple myeloma, breast and ovarian cancers even in heavily pretreated patients.18-26 Priming using chemotherapy is toxic and costly11 and new priming procedures need to be established, which is the background for this randomized pilot study. The hypothesis is that elimination of chemotherapy from the priming regimen may decrease the overall toxicity and the ability to collect a sufficient autograft which, however, may be circumvented by adding r-metHuSCF (Ancestim) to the priming regimen. The aim of this randomized phase II trial was to evaluate safety, toxicity and efficacy of growth factors in lymphoma patients considered candidates for high dose chemotherapy.
- Conditions
- Malignant Lymphoma
- Being tested
- r-metHuSCF and Filgrastim, Chemotherapy plus Filgrastim
- Keywords
- SCF, Priming, Mobilization, Lymphoma, Clinical Trial
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
r-metHuSCF and FilgrastimDrug
Also called Stem Cell Factor and G-CSF
Patients were randomized in a 1:1 ratio to either chemotherapy combined with 10 µg/kg/d Filgrastim (control arm B), administered by subcutaneous injection for 14 days, or the combination of 10 µg/kg/d Filgrastim and SCF administered subcutaneously at a dose of 20 µg/kg/d (experimental arm A) for 8 days. Different injection sites were used for each cytokine.
r-metHuSCF and FilgrastimDrug
Also called Stem Cell Factor and G-CSF
Patients were randomized in a 1:1 ratio to either chemotherapy combined with 10 µg/kg/d Filgrastim (control arm B), administered by subcutaneous injection for 14 days, or the combination of 10 µg/kg/d Filgrastim and SCF administered subcutaneously at a dose of 20 µg/kg/d (experimental arm A) for 8 days. Different injection sites were used for each cytokine.
Chemotherapy plus FilgrastimDrug
Also called Priming chemotherapy and G-CSF
Patients were randomized in a 1:1 ratio to either chemotherapy combined with 10 µg/kg/d Filgrastim (control arm B), administered by subcutaneous injection for 14 days, or the combination of 10 µg/kg/d Filgrastim and SCF administered subcutaneously at a dose of 20 µg/kg/d (experimental arm A) for 8 days. Different injection sites were used for each cytokine.
| Study group | Role | What they receive |
|---|---|---|
| r-metHuSCF and Filgrastim | Active comparator | Patients were randomized in a 1:1 ratio to either chemotherapy combined with 10 µg/kg/d Filgrastim (control arm B), administered by subcutaneous injection for 14 days, or the combination of 10 µg/kg/d Filgrastim and SCF administered subcutaneously at a dose of 20 µg/kg/d (experimental arm A) for 8 days. Different injection sites were used for each cytokine. Receives: Drug: r-metHuSCF and Filgrastim; Drug: Chemotherapy plus Filgrastim |
| Cyclophosphamide and Filgrastim | Active comparator | Patients were randomized in a 1:1 ratio to either chemotherapy combined with 10 µg/kg/d Filgrastim (control arm B), administered by subcutaneous injection for 14 days, or the combination of 10 µg/kg/d Filgrastim and SCF administered subcutaneously at a dose of 20 µg/kg/d (experimental arm A) for 8 days. Different injection sites were used for each cytokine. Receives: Drug: r-metHuSCF and Filgrastim; Drug: Chemotherapy plus Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Toxicity was assessed by morbidity, including unexpected adverse events associated with the priming and the transplantation phases during study, and measured and graded by CTC criteria.
Measured: From inclusion to 1 months post transplantation
Secondary outcomes (1)
To compare the time dependent level of blood circulating and harvested haematopoietic stem cells and progenitors (PBSC) in patients treated with either a combination of r-metHuSCF and Filgrastim, or conventional chemotherapy plus Filgrastim.
Measured: From inclusion to 1 months post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study startJan 1999
- Primary completionNov 2000
- Study completionNov 2009
Why it stopped: Study closed Nov 2000 by Amgen, who stopped drug delivery
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant LymphomaStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital, Copenhagen University Hospital, Rigshospitalet, Helsinki University Central Hospital, Turku University Hospital, University Hospital, Linkoeping, Umeå University, Oslo University Hospital, Nordic Lymphoma Group, Amgen
- Investigators
- Hans E Johnsen, MD DMSc, Principal investigator, Aalborg Hospital and Herlev University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016795
- Sponsor's protocol ID
- SCF 980266
- Other IDs
- H-KA-99040-GMS
- Acronym
- SCF980266
- Status last verified
- Nov 2009
- First submitted
- 18 Nov 2009
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Peripheral Blood Progenitor Cell Priming Comparing a Combination of r-metHuSCF and Filgrastim or Chemotherapy and Filgrastim on Mobilization and Engraftment in Patients With Relapsed or Refractory Lymphomas
- ClinicalTrials.gov ID
- NCT01016795
- Acronym / sponsor ID
- SCF980266 / SCF 980266
- Conditions
- Malignant Lymphoma
- Keywords
- SCF, Priming, Mobilization, Lymphoma, Clinical Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed Nov 2000 by Amgen, who stopped drug delivery
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Herlev Hospital, Copenhagen University Hospital, Rigshospitalet, Helsinki University Central Hospital, Turku University Hospital, University Hospital, Linkoeping, Umeå University, Oslo University Hospital, Nordic Lymphoma Group, Amgen
- Study start
- Jan 1999
- Primary completion
- Nov 2000 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 20 Nov 2009 (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.
Clinical Hypothesis:
It is expected that by removing chemotherapy and adding ancestim to the mobilization scheme in most of the subjects sufficient PBPC will be harvested with a minimum of toxicity and side effects.
Detailed description
Autologous stem cell transplantation is used to support high dose chemotherapy in haematological malignancies.1-2 Peripheral blood progenitor cells (PBPC) have replaced bone marrow cells as the preferred source for transplantation due to faster blood cell recovery.3-4 One variable of major impact for posttransplant care is the number of PBPC harvested.5-8 Therefore, several clinical studies have aimed to identify priming regimens that improve progenitor and stem cell mobilizations and collections without increased toxicity. Frequently, Filgrastim (r-met HuG-CSF) is administrated alone; however, Filgrastim combined with chemotherapy has proven more effective in context of CD34+ cell numbers harvested9-11 and this combination is considered the gold standard for priming and stem cell mobilization in relapsed malignant lymphoma.
Stem cell factor (SCF) is a glycoprotein growth factor that acts on haematopoietic blood cell progenitors.12 Whereas SCF alone exerts little colony-stimulating activity on normal human bone marrow cells in vitro, combination of SCF with other recombinant haematopoietic cytokines results in a synergistic increase in numbers of colonies.13 In vivo, the addition of SCF to G-CSF (Filgrastim) synergistically increases PBPC mobilization compared to Filgrastim alone.14-17 Several clinical trials have reported the ability of the combination of SCF with Filgrastim to mobilize PBPC in patients with lymphoma, multiple myeloma, breast and ovarian cancers even in heavily pretreated patients.18-26 Priming using chemotherapy is toxic and costly11 and new priming procedures need to be established, which is the background for this randomized pilot study. The hypothesis is that elimination of chemotherapy from the priming regimen may decrease the overall toxicity and the ability to collect a sufficient autograft which, however, may be circumvented by adding r-metHuSCF (Ancestim) to the priming regimen. The aim of this randomized phase II trial was to evaluate safety, toxicity and efficacy of growth factors in lymphoma patients considered candidates for high dose chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| r-metHuSCF and Filgrastim | Active comparator | Drug: r-metHuSCF and Filgrastim, Drug: Chemotherapy plus FilgrastimPatients were randomized in a 1:1 ratio to either chemotherapy combined with 10 µg/kg/d Filgrastim (control arm B), administered by subcutaneous injection for 14 days, or the combination of 10 µg/kg/d Filgrastim and SCF administered subcutaneously at a dose of 20 µg/kg/d (experimental arm A) for 8 days. Different injection sites were used for each cytokine. |
| Cyclophosphamide and Filgrastim | Active comparator | Drug: r-metHuSCF and Filgrastim, Drug: Chemotherapy plus FilgrastimPatients were randomized in a 1:1 ratio to either chemotherapy combined with 10 µg/kg/d Filgrastim (control arm B), administered by subcutaneous injection for 14 days, or the combination of 10 µg/kg/d Filgrastim and SCF administered subcutaneously at a dose of 20 µg/kg/d (experimental arm A) for 8 days. Different injection sites were used for each cytokine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects with Hodgkin's disease and non-Hodgkin lymphomas (Real classification)
- Age > 18 years and < 65 years
- ECOG performance status 0, 1 or 2
- Life expectancy of > 6 months with treatment
- ANC > or equal to 1.5 x 109/L, Platelets > or equal to 100 x 109/L
Key exclusion criteria (13 listed)
- Prior DexaBEAM or miniBEAM therapy and prior bone marrow or PBPC transplant
- Any history of seasonal or recurrent asthma within the preceding 10 years.
- Any history of anaphylactic / anaphylactoid-type event manifested by disseminated urticaria, laryngeal oedema, and / or bronchospasm (example, food, insect bites, etc.). Subjects with drug allergies, manifested solely by rash and / or urticaria, are not excluded
- Any history of angioedema or recurrent urticaria
- Clinical or microbiological evidence of infection at the date of enrollment.
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 |
|---|---|---|
| r-metHuSCF and FilgrastimAlso: Stem Cell Factor and G-CSFPatients were randomized in a 1:1 ratio to either chemotherapy combined with 10 µg/kg/d Filgrastim (control arm B), administered by subcutaneous injection for 14 days, or the combination of 10 µg/kg/d Filgrastim and SCF administered subcutaneously at a dose of 20 µg/kg/d (experimental arm A) for 8 days. Different injection sites were used for each cytokine. | Drug | Cyclophosphamide and Filgrastim, r-metHuSCF and Filgrastim |
| r-metHuSCF and FilgrastimAlso: Stem Cell Factor and G-CSFPatients were randomized in a 1:1 ratio to either chemotherapy combined with 10 µg/kg/d Filgrastim (control arm B), administered by subcutaneous injection for 14 days, or the combination of 10 µg/kg/d Filgrastim and SCF administered subcutaneously at a dose of 20 µg/kg/d (experimental arm A) for 8 days. Different injection sites were used for each cytokine. | Drug | r-metHuSCF and Filgrastim |
| Chemotherapy plus FilgrastimAlso: Priming chemotherapy and G-CSFPatients were randomized in a 1:1 ratio to either chemotherapy combined with 10 µg/kg/d Filgrastim (control arm B), administered by subcutaneous injection for 14 days, or the combination of 10 µg/kg/d Filgrastim and SCF administered subcutaneously at a dose of 20 µg/kg/d (experimental arm A) for 8 days. Different injection sites were used for each cytokine. | Drug | Cyclophosphamide and Filgrastim, r-metHuSCF and Filgrastim |
Primary outcome
Safety and Toxicity was assessed by morbidity, including unexpected adverse events associated with the priming and the transplantation phases during study, and measured and graded by CTC criteria.
Time frame: From inclusion to 1 months post transplantation
1 secondary outcome
To compare the time dependent level of blood circulating and harvested haematopoietic stem cells and progenitors (PBSC) in patients treated with either a combination of r-metHuSCF and Filgrastim, or conventional chemotherapy plus Filgrastim.
Time frame: From inclusion to 1 months post transplantation
Results and safety
The study was stopped early (reason given: Study closed Nov 2000 by Amgen, who stopped drug delivery). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 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.
Hans E Johnsen, MD DMSc principal investigator
Aalborg Hospital and Herlev University Hospital
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing r-metHuSCF and Filgrastim and Chemotherapy plus Filgrastim in people with Malignant Lymphoma, run by Aalborg University Hospital at 8 sites in 4 countries.
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 10 inclusion and 13 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: stopped early, as of the sponsor's last update on 25 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Denmark, Finland, Sweden, Norway. 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 was stopped early (reason given: Study closed Nov 2000 by Amgen, who stopped drug delivery). Results are not available in the source record.
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?
Safety and Toxicity was assessed by morbidity, including unexpected adverse events associated with the priming and the transplantation phases during study, and measured and graded by CTC criteria. (time frame: From inclusion to 1 months post transplantation). 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 25 Jun 2015.