Non-Hodgkin's Lymphoma or Hodgkin's DiseasePhase 2KGF Haplo AlloNCT00570999
Palifermin After Haploidentical PBSCT
A Phase 2 study testing Palifermin in people with Non-Hodgkin's Lymphoma or Hodgkin's Disease and Acute Leukaemia, run by European Society for Blood and Marrow Transplantation at 1 site in Germany.
Trial summary
This is a double blind, placebo controlled clinical trial, where patients with an advanced form of blood cancer are treated with haploidentical allogeneic peripheral blood progenitor cell (PBPC) transplant after which they are randomised to receive either placebo or a keratinocyte growth factor (Palifermin or… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-Hodgkin's Lymphoma or Hodgkin's Disease, Acute Leukaemia, Myelodysplastic Syndrome
- What is being tested?
- Palifermin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2008to Jan 2013
- 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
- Recipient:
- Chemosensitive low/high grade B-NHL or T-NHL, Multiple Myeloma (MM) in partial or complete remission
- ALL and AML, secondary AML and biphenotypic acute leukemia in complete remission (CR1 or CR2) or PR (only if ≤20% blasts in BM), Myelodysplastic syndrome (MDS)
- CML in chronic or accelerated phase
- Osteomyelofibrosis (OMF)
- Hodgkin lymphoma (HD) in partial or complete remission
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- Age ≥18 years, ≤ 65 years
- ECOG status ≤2
- Prior treatment with 3 or less different chemotherapy regimens (not cycles); prior local radiotherapy is allowed except radiation involving the thymus
- Adequate pulmonary function
- Left ventricular ejection fraction (LVEF) >30%
- Haploidentical related donor
- Failure to find matched related or matched unrelated donor and urgently requiring transplantation
- Planned conditioning regimen per Aversa or Würzburg protocol
- Women must be post-menopausal, sterile or use effective contraception and have a negative pregnancy test at study entry (β-HCG neg)
- Signed informed consent
- Donor:
- Healthy family member
- Selection based on typing of HLA-A, B, C, DR loci. Donor must be at least genotypically HLA-A, B, C, DR haploidentical to the patient, but must differ for 2-3 HLA allele(s) on the unshared haplotype
- Donors must be capable of undergoing leukapheresis, have adequate venous access, and be willing to undergo insertion of a central venous catheter should leukapheresis via peripheral vein be inadequate.
- Donors must agree to a 2nd donation of PBPCs in case of insufficient CD34+ cell collection or should patient fail to demonstrate sustained engraftment
- Signed informed consent
Who cannot join
- Recipient:
- History of or concurrent cancer (< 5 years ago) other than those named in inclusion criteria
- Primary chemorefractory disease
- CML in blast crisis
- MM with no or minor response to previous treatment
- Prior treatment with palifermin, or other keratinocyte growth factors
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- Documented hypersensitivity to palifermin, E. coli-derived proteins, or any component of the product
- Documented hypersensitivity to Prevenar vaccine or its components
- Prior allogeneic or tandem PBPC transplantation (no more than 1 previous autologous transplantation
- Prior total body irradiation
- Post thymectomy
- Major anticipated illness or organ failure incompatible with survival from PBPC transplantation
- Active chronic skin disease requiring therapy
- Active inflammatory bowel disease requiring therapy
- Active uncontrolled infection
- Sero-positive HIV
- Pregnancy or breast-feeding
- Active invasive fungal tissue infection (EORTC criteria)
- 30 days or less since receiving an investigational product or device in another clinical trial
- Concurrent enrolment in another trial is not permitted unless the purpose is for long-term follow-up/survival data only, or observational only
- Chronic pancreatitis or history of acute pancreatitis within 1 year prior to transplant
- Psychiatric disorder associated with incompliance
- Myocardial infarction less than 3 months pre enrolment or EF <30% as measured in echocardiography/laevoventriculography
- Infusion of retrovirally or other transduced cells are not permitted.
- Planned intravenous application of immunoglobulins is contraindicated throughout the study period.
- Donor lymphocyte infusions are not allowed.
- Donor:
- A positive HIV or HTLV-1 test or evidence of active/persistent viral hepatitis infection.
- Evidence of any other active infection
- Any medical condition (i.e. insulin-dependent diabetes, cardiovascular disorders, chronic inflammatory diseases) posing a health risk for peripheral blood stem cell harvest
- Hematopoietic or marrow function related disease interfering with the collection of sufficient numbers of normal progenitor cells
- Pregnancy or breast-feeding
- Any malignancy besides basal cell epithelioma or cured malignancy < 5 years ago
- Psychiatric disorder associated with incompliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Placebo-Controlled Double-Blind Phase II Study Applying Palifermin to Improve T-cell Immune Reconstitution After Haploidentical Allogeneic Peripheral Blood Progenitor Cell (PBPC) Transplantation
This is a double blind, placebo controlled clinical trial, where patients with an advanced form of blood cancer are treated with haploidentical allogeneic peripheral blood progenitor cell (PBPC) transplant after which they are randomised to receive either placebo or a keratinocyte growth factor (Palifermin or Kepivance®).
The function of Kepivance® is to stimulate the growth of epithelial cells. This drug has also been suggested to have an ability to help improve the reconstitution, or development, of the immune system after the transplantation.
The hypothesis is that the patients T-cell dependent humoral immune response to recall antigen (PrevenarTM) will be higher in in palifermin treated patients than in the placebo control group
- Conditions
- Non-Hodgkin's Lymphoma or Hodgkin's Disease, Acute Leukaemia, Myelodysplastic Syndrome, Chronic Myeloid Leukemia, Osteomyelofibrosis
- Being tested
- Palifermin, Placebo
- Keywords
- Peripheral blood stem cell transplantation, Palifermin, Kepivance, Prevenar, Placebo
- Medical subject headings
- Lymphoma, Non-Hodgkin, Hodgkin Disease, Myelodysplastic Syndromes, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaliferminDrug
Also called Keratinocyte growth factor, Kepivacine
60 mg/kg/day
PlaceboOther
Also called 0.9% saline
1,2 mL once daily
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Palifermin once daily at a dose of 60 mg/kg/day for 3 days before the start of the conditioning regimen and then for 3 consecutive days starting on the day of transplantation (days 0 to day +2 inclusively). Receives: Drug: Palifermin |
| Arm B | Placebo comparator | Placebo at a dose of 1.2 mL (saline 0,9%) once daily for 3 days before the start of the conditioning regimen and then for 3 consecutive days starting on the day of transplantation (days 0 to day +2 inclusively). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test palifermin's effect on the T-cell dependent humoral immune response to recall antigen (Prevenar™)
Measured: at study day +270 (20 days after the third Prevenar injection)
Secondary outcomes (4)
To assess if Palifermin improves T-cell reconstitution after haploidentical allogeneic transplantation
Measured: at study days: +240
To assess if Palifermin improves T-cell reconstitution after haploidentical allogeneic transplantation
Measured: Study days +210, +240, +270
To assess disease free survival (DFS) and overall survival (OS), incidence and duration of GvHD, incidence and severity of OM, and incidence and severity of infections
Measured: at 2 years
To assess drug related safety
Measured: at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startFeb 2008
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's Lymphoma or Hodgkin's DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Society for Blood and Marrow Transplantation
- Sponsor type
- Research network
- Collaborators
- Amgen
- Investigators
- Ruth Seggewiss, MD, Study chair, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570999
- Sponsor's protocol ID
- EudraCt: 2007-003241-32
- Acronym
- KGF Haplo Allo
- Status last verified
- May 2012
- First submitted
- 10 Dec 2007
- Last updated
- 10 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Placebo-Controlled Double-Blind Phase II Study Applying Palifermin to Improve T-cell Immune Reconstitution After Haploidentical Allogeneic Peripheral Blood Progenitor Cell (PBPC) Transplantation
- ClinicalTrials.gov ID
- NCT00570999
- Acronym / sponsor ID
- KGF Haplo Allo / EudraCt: 2007-003241-32
- Conditions
- Non-Hodgkin's Lymphoma or Hodgkin's Disease, Acute Leukaemia, Myelodysplastic Syndrome, Chronic Myeloid Leukemia, Osteomyelofibrosis
- Keywords
- Peripheral blood stem cell transplantation, Palifermin, Kepivance, Prevenar, Placebo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- European Society for Blood and Marrow TransplantationResearch network
- Collaborators
- Amgen
- Study start
- Feb 2008
- Study completion
- Jan 2013 (estimated)
- First posted
- 11 Dec 2007 (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.
This is a double blind, placebo controlled clinical trial, where patients with an advanced form of blood cancer are treated with haploidentical allogeneic peripheral blood progenitor cell (PBPC) transplant after which they are randomised to receive either placebo or a keratinocyte growth factor (Palifermin or Kepivance®).
The function of Kepivance® is to stimulate the growth of epithelial cells. This drug has also been suggested to have an ability to help improve the reconstitution, or development, of the immune system after the transplantation.
The hypothesis is that the patients T-cell dependent humoral immune response to recall antigen (PrevenarTM) will be higher in in palifermin treated patients than in the placebo control group
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 |
|---|---|---|
| Arm A | Experimental | Drug: PaliferminPalifermin once daily at a dose of 60 mg/kg/day for 3 days before the start of the conditioning regimen and then for 3 consecutive days starting on the day of transplantation (days 0 to day +2 inclusively). |
| Arm B | Placebo comparator | Other: PlaceboPlacebo at a dose of 1.2 mL (saline 0,9%) once daily for 3 days before the start of the conditioning regimen and then for 3 consecutive days starting on the day of transplantation (days 0 to day +2 inclusively). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Chemosensitive low/high grade B-NHL or T-NHL, Multiple Myeloma (MM) in partial or complete remission
- ALL and AML, secondary AML and biphenotypic acute leukemia in complete remission (CR1 or CR2) or PR (only if ≤20% blasts in BM), Myelodysplastic syndrome (MDS)
- CML in chronic or accelerated phase
- Osteomyelofibrosis (OMF)
- Hodgkin lymphoma (HD) in partial or complete remission
Key exclusion criteria (34 listed)
- History of or concurrent cancer (< 5 years ago) other than those named in inclusion criteria
- Primary chemorefractory disease
- CML in blast crisis
- MM with no or minor response to previous treatment
- Prior treatment with palifermin, or other keratinocyte growth factors
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 |
|---|---|---|
| PaliferminAlso: Keratinocyte growth factor, Kepivacine60 mg/kg/day | Drug | Arm A |
| PlaceboAlso: 0.9% saline1,2 mL once daily | Other | Arm B |
Primary outcome
To test palifermin's effect on the T-cell dependent humoral immune response to recall antigen (Prevenar™)
Time frame: at study day +270 (20 days after the third Prevenar injection)
4 secondary outcomes
To assess if Palifermin improves T-cell reconstitution after haploidentical allogeneic transplantation
Time frame: at study days: +240
To assess if Palifermin improves T-cell reconstitution after haploidentical allogeneic transplantation
Time frame: Study days +210, +240, +270
To assess disease free survival (DFS) and overall survival (OS), incidence and duration of GvHD, incidence and severity of OM, and incidence and severity of infections
Time frame: at 2 years
To assess drug related safety
Time frame: at 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2012.
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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.
Ruth Seggewiss, MD study chair
Wuerzburg University Hospital
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 Palifermin in people with Non-Hodgkin's Lymphoma or Hodgkin's Disease and Acute Leukaemia, run by European Society for Blood and Marrow Transplantation at 1 site in Germany.
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 22 inclusion and 34 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: withdrawn, as of the sponsor's last update on 10 May 2012. 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 Germany. 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. Some participants in this study may receive a placebo. 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 withdrawn before enrolling participants, so there are no results.
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?
To test palifermin's effect on the T-cell dependent humoral immune response to recall antigen (Prevenar™) (time frame: at study day +270 (20 days after the third Prevenar injection)). 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 10 May 2012.