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Clinical picture: SCT (Stem Cell Transplantation and Cellular Therapies)

Trial: HOVON 107 MOBILIZATION


News
1. Overview
Study details
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms


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News


HO107 news

21FEB2017: Study is closed for inclusion of new donors + patients because the primary endpoint has been reached. Follow Up phase continues until 2 years after registration of both donor and patient.

 

01JUL2016: Please note that the target of study subjects is 44. 30 donors+patients registered for subcutaneous arm (= current protocol) and 14 donors+patients were enrolled in the iv arm during the primary protocol phase (= before amendment of study design). Sites will be notified by email once the study is almost closed. 

 

07SEP2015: Amendment of study design (closure of iv arm) is submitted and approved by Dutch EC. All sites are deactivated until required documents (LI sign. page protocol and local versions of ICF) are send to the HDC. 

 

24NOV2014: After revision of the DSMB report no safety issues have arisen. The study is reopened.

 

14OCT2014: Following the advice of the DSMB, it is decided to temporarily close the study

 

23AUG2011: Please note: patient and donor need to sign a seperate informed consent.

 

The informed consent for a donor you can find under download documentation/forms -> General -> Patient Information & IC form (NL)

 

The informed consent for a patient you can find under download documentation/forms -> Other documents -> ho107 icf patient template v4 11may2011


1. Overview



Summary

The feasibility and efficacy of subcutaneous Plerixafor for mobilization of peripheral blood stem cells in allogeneic HLA–identical sibling donors: a prospective phase II study.
(Study design was amended in September 2015. Initial study title: The feasibility and efficacy of subcutaneous and intravenous Plerixafor for mobilization of peripheral blood stem cells in allogeneic HLA–identical sibling donors: a randomized phase II study).


Status

closed


Members

HOVON



Study details



Type of study

Prospective Phase II study


Echelon level

Level A


Type of monitoring for this study

Site evaluation visits


Target number of patients

44


Current number of patients

38


Date of activation

07-Jun-2011


Approved by

EudraCTnr.:2010-023436-16


Study objectives

Primary:
•To determine the feasibility of plerixafor 320 μg/kg subcutaneously to harvest a sufficient number of peripheral blood stem cells in healthy HLA-matched sibling donors.

Secundary:
donors:
•To determine the efficacy of plerixafor subcutaneous. Efficacy will be determined as follows: The absolute number of CD34+ cells collected in 1 liter processed volume.
•To determine the time interval that is required to obtain 2.0x 106 CD34 + cells from start of mobilization procedure
•Pharmacokinetics: to determine the number of CD34+ cells in the peripheral blood at regular intervals after the administration of plerixafor.
•To determine the number of CD34+ cells in the peripheral blood as well as in the collected stem cells at regular intervals during the stem cell apheresis.
•To determine the phenotype of plerixafor mobilized and collected CD34+ cells including progenitor cells, dendritic cells and regulatory T-cells both in peripheral blood and collected stem cells.
•To document adverse events grade 2-4 during and directly following mobilization by plerixafor 320 μg/kg subcutaneously.

Patients:
•To document engraftment 30, 60 and 90 days after transplantation with an allograft harvested after mobilization with plerixafor 320 μg/kg subcutaneous. Engraftment is defined as the first of 3 consecutive days with an absolute neutrophil count (ANC) of at least 0.5 × 109/l
•To document the day of hematopoietic reconstitution for neutrophils and platelets. This is defined as the first of 3 consecutive days of ANC ≥ 0.5x 106/L and platelets > 50x109/L
•To study chimerism in peripheral blood and T-cells 30, 60, and 90 days, and chimerism in bone marrow 90 days after transplantation with an allograft harvested after mobilization with plerixafor 320 μg/kg subcutaneously.
•To evaluate the incidence and grade of graft versus host disease (GVHD).


2. Patient eligibility criteria



Inclusion criteria

Donor inclusion criteria:
•HLA identical sibling donor
•Age 18-60 years inclusive
•Hematologic parameters within normal limits
•Capable of undergoing leucapheresis: adequate venous access. Must be willing to undergo insertion of a central catheter should leucapheresis via peripheral vein be inadequate
•Willing and able to have bone marrow aspiration if there is mobilization failure
•Negative pregnancy test at study entry for women of childbearing potential
•Willing and able to use adequate contraception during the mobilization and collection period
•Written informed consent from donor

Patient inclusion criteria:
•Age 18-65 years inclusive
•Patients with a cytopathologically confirmed diagnosis of:
De novo Acute Myeloid Leukemia according to WHO classification in first complete remission (excluding acute promyelocytic leukemia)
Therapy related AML/RAEB in first complete remission
Myelodysplasia RA(RS)/RCMD with IPSS ≥ 1.5
Myelodysplasia refractory anemia with excess of blasts (RAEB) with IPSS ≥ 1.5 in first complete remission
• Biphenotypic leukemia in first complete remission OR
De novo B or T Lineage Acute Lymphatic Leukemia in first complete remission.
•Multiple myeloma, not included in other transplant study
•Hodgkin Lymphoma
•Non-Hodgkin lymphoma
•Chronic lymfocytic leukemia
•Chronic myeloid leukemia
•WHO performance score 0,1 or2
•Patients should have an HLA- identical sibling donor
•Life expectancy >3 months
•Negative pregnancy test at study entry for women of childbearing potential
•Willing and able to use adequate contraception
•Written informed consent from patient


Exclusion criteria

Donor exclusion criteria:
•Monozygotic twin
•Unstable hypertension requiring more than 1 medication.
•Positive serology for hepatitis C or HbsAg
•Treatment with other investigational drugs
•HIV positivity
•Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
•Pregnant or breastfeeding female subject

Patient exclusion criteria
•Cardiac dysfunction as defined by:
Myocardial infarction within the last 6 months of study entry
Reduced left ventricular function with an ejection fraction < 50% as measured by MUGA scan or echocardiogram,
Unstable angina
Unstable cardiac arrhytmias
•Severe pulmonary dysfunction (CTCAE grade 3-4, see appendixB)
•Severe neurological or psychiatric disease
•Significant hepatic dysfunction (serum bilirubin ≥ 1.5 times upper limit of normal or transaminases ≥ 2.5 times upper limit of normal)
•Significant renal dysfunction (creatinine clearance < 50 ml/min after rehydration)
•Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.)
•Patient known to be HIV-positive
•Pregnant or breast-feeding female patients.
•Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
•Presence of other active malignancy or a history of active malignancy during the past 5 years, other than non melanoma skin cancer, stage 0 cervical carcinoma, or treated early-stage prostate cancer provided that prostate-specific antigen is within normal limits


3. Registration (& randomization) of patients



Registration

Central registration at the HOVON Data Center:
Erasmus MC Cancer Institute, Clinical Trial Center (Hs-423)
P.O. Box 2040
NL-3000 CA Rotterdam
Phone number: +31 10 704 1560 (working days 9.00-17.00)
Fax number: +31 10 704 1028
TOP address: http://www.hdc.hovon.nl/top


Registration criteria

The following information will be requested:



PLEASE NOTE PATIENT AND DONOR NEED TO SIGN A SEPERATE INFORMED CONSENT;

Protocol number
Institution name
Name of caller/responsible investigator
Local patient/donor code (optional)
Sex patient/donor
Date of birth patient/donor
Date written informed consent patient/donor
Specific items donor gives consent for (see ICF)
Eligibility criteria patient/donor


4. Participating parties



Principal Investigator(s)

Mw. Dr. G.E. de Greef (Erasmus MC - Daniel)


Co-Investigator(s)

Prof. Dr. J.J. Cornelissen (Erasmus MC - Daniel)
Mw. Dr. E.J. Petersen (UMCU)


Coordinating Investigator(s)

Dr. D. Niederwieser (University of Leipzig)


Statistician(s)

Dhr. Dr. B. van der Holt (Erasmus MC - Daniel)


Central Data Manager(s)

Mw. T. van Dijk (Erasmus MC - Daniel)


Monitor - Site Evaluation Visits

Mw. W.M Keller (Erasmus MC - Daniel)
Mw. J. Kloezeman (Erasmus MC - Daniel)
MonitorTeamCTC (Erasmus MC - Daniel)


Other functions

Central Coordinator - Special Investigations - Dhr. Dr. E. Braakman (Erasmus MC - Medische Faculteit)


5. Participating sites



Site
Included patients *
DE-Leipzig-University of Leipzig
3
NL-Amsterdam-VUMC
3
NL-Rotterdam-Erasmus MC - Daniel
29
NL-Utrecht-UMCU
3

* Please note that if TOP is not used to register patients for a study, the number of patients shown is zero.

6. Instruction videos



7. Download documentation / forms


 Protocol



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