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Stem Cell Factor (SCF) Priming of Haematopoietic Stem Cell Grafts in Malignant Lymphoma (SCF980266)

Primary Purpose

Malignant Lymphoma

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
r-metHuSCF and Filgrastim
r-metHuSCF and Filgrastim
Chemotherapy plus Filgrastim
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Lymphoma focused on measuring SCF, Priming, Mobilization, Lymphoma, Clinical Trial

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects with Hodgkin's disease and non-Hodgkin lymphomas (Real classification)

    • in relapse
    • refractory to initial chemotherapy
    • with partial response after initial therapy
  • Age > 18 years and < 65 years
  • ECOG performance status 0, 1 or 2
  • Life expectancy of > 6 months with treatment
  • ANC > or equal to 1.5 x 109/L, Platelets > or equal to 100 x 109/L
  • Serum creatinine < or equal to 150 µmol/L, bilirubin, aspartate aminotransferase (ASAT), and alanine aminotransferase (ALAT) less than twice the upper limit defined at the investigating laboratory
  • Prior to mobilization chemotherapy subject has given written informed consent, personally dated

Exclusion Criteria:

  • Prior DexaBEAM or miniBEAM therapy and prior bone marrow or PBPC transplant
  • Any history of seasonal or recurrent asthma within the preceding 10 years.
  • Any history of anaphylactic / anaphylactoid-type event manifested by disseminated urticaria, laryngeal oedema, and / or bronchospasm (example, food, insect bites, etc.). Subjects with drug allergies, manifested solely by rash and / or urticaria, are not excluded
  • Any history of angioedema or recurrent urticaria
  • Clinical or microbiological evidence of infection at the date of enrollment.
  • Subjects with a concurrent malignancy
  • Significant non-malignant disease including documented HIV infection, uncontrolled hypertension, unstable angina, congestive heart failure, poorly controlled diabetes, coronary angioplasty within six months, myocardial infarction within the last six months, or uncontrolled atrial or ventricular cardiac arrhythmias
  • Pregnant or breast feeding subjects or those of child-bearing potential who are not using adequate contraceptive precautions
  • Concurrent enrollment on any other protocol using an investigational drug
  • Haematopoietic growth factors administered within one week of study entry
  • Subjects with a psychiatric, addictive or any disorder which compromises ability to give truly informed consent for participation in this study
  • Known sensitivity to E. coli derived products
  • Concurrent use of beta adrenergic blocking agents

Sites / Locations

  • Aalborg Hospital
  • Rigshospitalet
  • Herlev University Hospital
  • University Hospital Helsinki
  • University Hospital Turku
  • Radiumhospitalet
  • University Hospital Linköping
  • University Hospital Umeå

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

r-metHuSCF and Filgrastim

Cyclophosphamide and Filgrastim

Arm Description

Patients were randomized in a 1:1 ratio to either chemotherapy combined with 10 µg/kg/d Filgrastim (control arm B), administered by subcutaneous injection for 14 days, or the combination of 10 µg/kg/d Filgrastim and SCF administered subcutaneously at a dose of 20 µg/kg/d (experimental arm A) for 8 days. Different injection sites were used for each cytokine.

Patients were randomized in a 1:1 ratio to either chemotherapy combined with 10 µg/kg/d Filgrastim (control arm B), administered by subcutaneous injection for 14 days, or the combination of 10 µg/kg/d Filgrastim and SCF administered subcutaneously at a dose of 20 µg/kg/d (experimental arm A) for 8 days. Different injection sites were used for each cytokine.

Outcomes

Primary Outcome Measures

Safety and Toxicity was assessed by morbidity, including unexpected adverse events associated with the priming and the transplantation phases during study, and measured and graded by CTC criteria.

Secondary Outcome Measures

To compare the time dependent level of blood circulating and harvested haematopoietic stem cells and progenitors (PBSC) in patients treated with either a combination of r-metHuSCF and Filgrastim, or conventional chemotherapy plus Filgrastim.

Full Information

First Posted
November 18, 2009
Last Updated
June 24, 2015
Sponsor
Aalborg University Hospital
Collaborators
Herlev Hospital, Rigshospitalet, Denmark, Helsinki University Central Hospital, Turku University Hospital, University Hospital, Linkoeping, Umeå University, Oslo University Hospital, Nordic Lymphoma Group, Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT01016795
Brief Title
Stem Cell Factor (SCF) Priming of Haematopoietic Stem Cell Grafts in Malignant Lymphoma
Acronym
SCF980266
Official Title
A Randomized Study of Peripheral Blood Progenitor Cell Priming Comparing a Combination of r-metHuSCF and Filgrastim or Chemotherapy and Filgrastim on Mobilization and Engraftment in Patients With Relapsed or Refractory Lymphomas
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Terminated
Why Stopped
Study closed Nov 2000 by Amgen, who stopped drug delivery
Study Start Date
January 1999 (undefined)
Primary Completion Date
November 2000 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Aalborg University Hospital
Collaborators
Herlev Hospital, Rigshospitalet, Denmark, Helsinki University Central Hospital, Turku University Hospital, University Hospital, Linkoeping, Umeå University, Oslo University Hospital, Nordic Lymphoma Group, Amgen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Clinical Hypothesis: It is expected that by removing chemotherapy and adding ancestim to the mobilization scheme in most of the subjects sufficient PBPC will be harvested with a minimum of toxicity and side effects.
Detailed Description
Autologous stem cell transplantation is used to support high dose chemotherapy in haematological malignancies.1-2 Peripheral blood progenitor cells (PBPC) have replaced bone marrow cells as the preferred source for transplantation due to faster blood cell recovery.3-4 One variable of major impact for posttransplant care is the number of PBPC harvested.5-8 Therefore, several clinical studies have aimed to identify priming regimens that improve progenitor and stem cell mobilizations and collections without increased toxicity. Frequently, Filgrastim (r-met HuG-CSF) is administrated alone; however, Filgrastim combined with chemotherapy has proven more effective in context of CD34+ cell numbers harvested9-11 and this combination is considered the gold standard for priming and stem cell mobilization in relapsed malignant lymphoma. Stem cell factor (SCF) is a glycoprotein growth factor that acts on haematopoietic blood cell progenitors.12 Whereas SCF alone exerts little colony-stimulating activity on normal human bone marrow cells in vitro, combination of SCF with other recombinant haematopoietic cytokines results in a synergistic increase in numbers of colonies.13 In vivo, the addition of SCF to G-CSF (Filgrastim) synergistically increases PBPC mobilization compared to Filgrastim alone.14-17 Several clinical trials have reported the ability of the combination of SCF with Filgrastim to mobilize PBPC in patients with lymphoma, multiple myeloma, breast and ovarian cancers even in heavily pretreated patients.18-26 Priming using chemotherapy is toxic and costly11 and new priming procedures need to be established, which is the background for this randomized pilot study. The hypothesis is that elimination of chemotherapy from the priming regimen may decrease the overall toxicity and the ability to collect a sufficient autograft which, however, may be circumvented by adding r-metHuSCF (Ancestim) to the priming regimen. The aim of this randomized phase II trial was to evaluate safety, toxicity and efficacy of growth factors in lymphoma patients considered candidates for high dose chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Lymphoma
Keywords
SCF, Priming, Mobilization, Lymphoma, Clinical Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
r-metHuSCF and Filgrastim
Arm Type
Active Comparator
Arm Description
Patients were randomized in a 1:1 ratio to either chemotherapy combined with 10 µg/kg/d Filgrastim (control arm B), administered by subcutaneous injection for 14 days, or the combination of 10 µg/kg/d Filgrastim and SCF administered subcutaneously at a dose of 20 µg/kg/d (experimental arm A) for 8 days. Different injection sites were used for each cytokine.
Arm Title
Cyclophosphamide and Filgrastim
Arm Type
Active Comparator
Arm Description
Patients were randomized in a 1:1 ratio to either chemotherapy combined with 10 µg/kg/d Filgrastim (control arm B), administered by subcutaneous injection for 14 days, or the combination of 10 µg/kg/d Filgrastim and SCF administered subcutaneously at a dose of 20 µg/kg/d (experimental arm A) for 8 days. Different injection sites were used for each cytokine.
Intervention Type
Drug
Intervention Name(s)
r-metHuSCF and Filgrastim
Other Intervention Name(s)
Stem Cell Factor and G-CSF
Intervention Description
Patients were randomized in a 1:1 ratio to either chemotherapy combined with 10 µg/kg/d Filgrastim (control arm B), administered by subcutaneous injection for 14 days, or the combination of 10 µg/kg/d Filgrastim and SCF administered subcutaneously at a dose of 20 µg/kg/d (experimental arm A) for 8 days. Different injection sites were used for each cytokine.
Intervention Type
Drug
Intervention Name(s)
r-metHuSCF and Filgrastim
Other Intervention Name(s)
Stem Cell Factor and G-CSF
Intervention Description
Patients were randomized in a 1:1 ratio to either chemotherapy combined with 10 µg/kg/d Filgrastim (control arm B), administered by subcutaneous injection for 14 days, or the combination of 10 µg/kg/d Filgrastim and SCF administered subcutaneously at a dose of 20 µg/kg/d (experimental arm A) for 8 days. Different injection sites were used for each cytokine.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy plus Filgrastim
Other Intervention Name(s)
Priming chemotherapy and G-CSF
Intervention Description
Patients were randomized in a 1:1 ratio to either chemotherapy combined with 10 µg/kg/d Filgrastim (control arm B), administered by subcutaneous injection for 14 days, or the combination of 10 µg/kg/d Filgrastim and SCF administered subcutaneously at a dose of 20 µg/kg/d (experimental arm A) for 8 days. Different injection sites were used for each cytokine.
Primary Outcome Measure Information:
Title
Safety and Toxicity was assessed by morbidity, including unexpected adverse events associated with the priming and the transplantation phases during study, and measured and graded by CTC criteria.
Time Frame
From inclusion to 1 months post transplantation
Secondary Outcome Measure Information:
Title
To compare the time dependent level of blood circulating and harvested haematopoietic stem cells and progenitors (PBSC) in patients treated with either a combination of r-metHuSCF and Filgrastim, or conventional chemotherapy plus Filgrastim.
Time Frame
From inclusion to 1 months post transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with Hodgkin's disease and non-Hodgkin lymphomas (Real classification) in relapse refractory to initial chemotherapy with partial response after initial therapy Age > 18 years and < 65 years ECOG performance status 0, 1 or 2 Life expectancy of > 6 months with treatment ANC > or equal to 1.5 x 109/L, Platelets > or equal to 100 x 109/L Serum creatinine < or equal to 150 µmol/L, bilirubin, aspartate aminotransferase (ASAT), and alanine aminotransferase (ALAT) less than twice the upper limit defined at the investigating laboratory Prior to mobilization chemotherapy subject has given written informed consent, personally dated Exclusion Criteria: Prior DexaBEAM or miniBEAM therapy and prior bone marrow or PBPC transplant Any history of seasonal or recurrent asthma within the preceding 10 years. Any history of anaphylactic / anaphylactoid-type event manifested by disseminated urticaria, laryngeal oedema, and / or bronchospasm (example, food, insect bites, etc.). Subjects with drug allergies, manifested solely by rash and / or urticaria, are not excluded Any history of angioedema or recurrent urticaria Clinical or microbiological evidence of infection at the date of enrollment. Subjects with a concurrent malignancy Significant non-malignant disease including documented HIV infection, uncontrolled hypertension, unstable angina, congestive heart failure, poorly controlled diabetes, coronary angioplasty within six months, myocardial infarction within the last six months, or uncontrolled atrial or ventricular cardiac arrhythmias Pregnant or breast feeding subjects or those of child-bearing potential who are not using adequate contraceptive precautions Concurrent enrollment on any other protocol using an investigational drug Haematopoietic growth factors administered within one week of study entry Subjects with a psychiatric, addictive or any disorder which compromises ability to give truly informed consent for participation in this study Known sensitivity to E. coli derived products Concurrent use of beta adrenergic blocking agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans E Johnsen, MD DMSc
Organizational Affiliation
Aalborg Hospital and Herlev University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Herlev University Hospital
City
Copenhagen
Country
Denmark
Facility Name
University Hospital Helsinki
City
Helsinki
Country
Finland
Facility Name
University Hospital Turku
City
Turku
Country
Finland
Facility Name
Radiumhospitalet
City
Oslo
Country
Norway
Facility Name
University Hospital Linköping
City
Linköping
Country
Sweden
Facility Name
University Hospital Umeå
City
Umeå
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Stem Cell Factor (SCF) Priming of Haematopoietic Stem Cell Grafts in Malignant Lymphoma

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