Palifermin After Haploidentical PBSCT

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