Back to results

Palifermin After Haploidentical PBSCT (KGF Haplo Allo)

Primary Purpose

Non-Hodgkin's Lymphoma or Hodgkin's Disease, Acute Leukaemia, Myelodysplastic Syndrome

Status

Withdrawn

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Palifermin

Placebo

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma or Hodgkin's Disease focused on measuring Peripheral blood stem cell transplantation, Palifermin, Kepivance, Prevenar, Placebo

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dr Ruth Seggewiss

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm A

Arm B

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00570999

First Posted

December 10, 2007

Last Updated

May 9, 2012

Sponsor

European Society for Blood and Marrow Transplantation

Collaborators

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT00570999

Brief Title

Palifermin After Haploidentical PBSCT

Acronym

KGF Haplo Allo

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 Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Withdrawn

Study Start Date

February 2008 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

European Society for Blood and Marrow Transplantation

Collaborators

Amgen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

Arm Title

Arm B

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Palifermin

Other Intervention Name(s)

Keratinocyte growth factor, Kepivacine

Intervention Description

60 mg/kg/day

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

0.9% saline

Intervention Description

1,2 mL once daily

Primary Outcome Measure Information:

Title

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)

Secondary Outcome Measure Information:

Title

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

Time Frame

at study days: +240

Title

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

Time Frame

Study days +210, +240, +270

Title

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

Title

To assess drug related safety

Time Frame

at 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ruth Seggewiss, MD

Organizational Affiliation

University Hospital of Würzburg

Official's Role

Study Chair

Facility Information:

Facility Name

Dr Ruth Seggewiss

City

Würzburg

ZIP/Postal Code

97080

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Palifermin After Haploidentical PBSCT

We'll reach out to this number within 24 hrs