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Palifermin After Haploidentical PBSCT

Information source: European Group for Blood and Marrow Transplantation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-Hodgkin's Lymphoma or Hodgkin's Disease; Acute Leukaemia; Myelodysplastic Syndrome; Chronic Myeloid Leukemia; Osteomyelofibrosis

Intervention: Palifermin (Drug); Placebo (Other)

Phase: Phase 2

Status: Withdrawn

Sponsored by: European Group for Blood and Marrow Transplantation

Official(s) and/or principal investigator(s):
Ruth Seggewiss, MD, Study Chair, Affiliation: University Hospital of Würzburg

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 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

Clinical Details

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

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

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

Secondary outcome:

To assess if Palifermin improves T-cell reconstitution after haploidentical allogeneic transplantation

To assess if Palifermin improves T-cell reconstitution after haploidentical allogeneic transplantation

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

To assess drug related safety

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Dr Ruth Seggewiss, Würzburg 97080, Germany
Additional Information

Starting date: February 2008
Last updated: May 9, 2012

Page last updated: August 23, 2015

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