Palifermin After Haploidentical PBSCT (KGF Haplo Allo)

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Amgen
Information provided by:
European Group for Blood and Marrow Transplantation
ClinicalTrials.gov Identifier:
NCT00570999
First received: December 10, 2007
Last updated: May 9, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Non-Hodgkin's Lymphoma or Hodgkin's Disease
Acute Leukaemia
Myelodysplastic Syndrome
Chronic Myeloid Leukemia
Osteomyelofibrosis
Drug: Palifermin
Other: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by European Group for Blood and Marrow Transplantation:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess if Palifermin improves T-cell reconstitution after haploidentical allogeneic transplantation [ Time Frame: at study days: +240 ] [ Designated as safety issue: No ]
  • To assess if Palifermin improves T-cell reconstitution after haploidentical allogeneic transplantation [ Time Frame: Study days +210, +240, +270 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To assess drug related safety [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: February 2008
Estimated Study Completion Date: January 2013
Arms Assigned Interventions
Experimental: Arm A
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).
Drug: Palifermin
60 mg/kg/day
Other Names:
  • Keratinocyte growth factor
  • Kepivacine
Placebo Comparator: Arm B
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).
Other: Placebo
1,2 mL once daily
Other Name: 0.9% saline

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570999

Locations
Germany
Dr Ruth Seggewiss
Würzburg, Germany, 97080
Sponsors and Collaborators
European Group for Blood and Marrow Transplantation
Amgen
Investigators
Study Chair: Ruth Seggewiss, MD University Hospital of Würzburg
  More Information

No publications provided

Responsible Party: Kim Champion, EBMT (European Group for Blood and Marrow Transplantation)
ClinicalTrials.gov Identifier: NCT00570999     History of Changes
Other Study ID Numbers: EudraCt: 2007-003241-32
Study First Received: December 10, 2007
Last Updated: May 9, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Belgium: Federal Agency for Medicinal Products and Health Products
Italy: Ethics Committee

Keywords provided by European Group for Blood and Marrow Transplantation:
Peripheral blood stem cell transplantation
Palifermin
Kepivance
Prevenar
Placebo

Additional relevant MeSH terms:
Hodgkin Disease
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoma
Lymphoma, Non-Hodgkin
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on July 26, 2014