Palifermin After Haploidentical PBSCT

NCT00570999 | Withdrawn Phase 2 DMC

• 1 other identifier: EudraCt: 2007-003241-32
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Non-Hodgkin's Lymphoma or Hodgkin's Disease; Acute Leukaemia; Myelodysplastic Syndrome; Chronic Myeloid Leukemia; Osteomyelofibrosis

Keywords

Peripheral blood stem cell transplantation; Palifermin; Kepivance; Prevenar; Placebo

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (4)

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

  at study days: +240

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

  Study days +210, +240, +270

• 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

  at 2 years

• To assess drug related safety

  at 2 years

Study Arms (2)

Arm A

EXPERIMENTAL

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

Arm B

PLACEBO COMPARATOR

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

Interventions

Palifermin DRUG

60 mg/kg/day

Also known as: Keratinocyte growth factor, Kepivacine

Arm A

Placebo OTHER

1,2 mL once daily

Also known as: 0.9% saline

Arm B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Recipient:
• 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

Sponsors & Collaborators

• European Society for Blood and Marrow Transplantation: lead
• Amgen: collaborator

Study Sites (1)

Dr Ruth Seggewiss

Würzburg, 97080, Germany

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Hodgkin Disease; Myelodysplastic Syndromes; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Fibroblast Growth Factor 7; Saline Solution

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Hematologic Diseases; Leukemia, Myeloid; Leukemia; Myeloproliferative Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibroblast Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ruth Seggewiss, MD

  University Hospital of Würzburg

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: December 10, 2007
• First Posted: December 11, 2007
• Study Start: February 1, 2008
• Study Completion: January 1, 2013
• Last Updated: May 10, 2012

Record last verified: 2012-05

Locations

DE (1)