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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

Phase 2
18 Years
65 Years
Not Enrolling
Non-Hodgkin's Lymphoma or Hodgkin's Disease, Acute Leukaemia, Myelodysplastic Syndrome, Chronic Myeloid Leukemia, Osteomyelofibrosis

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Trial Information

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

Inclusion Criteria:


- 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

- 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

- 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


- 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

Exclusion Criteria:


- History of or concurrent cancer (< 5 years ago) other than those named in inclusion

- 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

- 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

- Prior total body irradiation

- Post thymectomy

- Major anticipated illness or organ failure incompatible with survival from PBPC

- 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

- Psychiatric disorder associated with incompliance

- Myocardial infarction less than 3 months pre enrolment or EF <30% as measured in

- 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.


- A positive HIV or HTLV-1 test or evidence of active/persistent viral hepatitis

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

To test palifermin's effect on the T-cell dependent humoral immune response to recall antigen (Prevenar™)

Outcome Time Frame:

at study day +270 (20 days after the third Prevenar injection)

Safety Issue:


Principal Investigator

Ruth Seggewiss, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital of Würzburg


Germany: Federal Institute for Drugs and Medical Devices

Study ID:

EudraCt: 2007-003241-32



Start Date:

February 2008

Completion Date:

January 2013

Related Keywords:

  • Non-Hodgkin's Lymphoma or Hodgkin's Disease
  • Acute Leukaemia
  • Myelodysplastic Syndrome
  • Chronic Myeloid Leukemia
  • Osteomyelofibrosis
  • Peripheral blood stem cell transplantation
  • Palifermin
  • Kepivance
  • Prevenar
  • Placebo
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Myelodysplastic Syndromes
  • Preleukemia