Palifermin After Haploidentical PBSCT (KGF Haplo Allo)

Inclusion Criteria:

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
• 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

Exclusion Criteria:

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
• 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