Primary Objective: * To confirm the safety profile of plerixafor to mobilise stem cells when used in patients with lymphoma or MM who are eligible to undergo treatment with an autologous haematopoietic stem cell transplantSecondary Objectives:* To…
ID
Source
Brief title
Condition
- Other condition
- Lymphomas non-Hodgkin's unspecified histology
Synonym
Health condition
In aanvulling op bovenstaande: Multipel myeloom, ziekte van Hodgkin
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patient safety will be assessed based on clinical laboratory evaluations and
monitoring of AEs. The investigator will grade AEs using the NCI CTCAE version
3.0.
Adverse events will be recorded as follows:
* During the screening period (from signing consent form to first dose of
G-CSF), only AEs related to study procedures will be recorded.
* All grade 3 and 4 AEs and all serious adverse events (SAEs) that occur from
the first dose of G-CSF up to 30 days after the last dose of plerixafor or the
first dose of myeloablative chemotherapy, whichever occurs first, will be
documented.
* Any AE regardless of grade that occurs during the immediate post-injection
time period (30 minutes to 1 hour after plerixafor injection) will be recorded.
* Any AE, regardless of grade, that results in permanent discontinuation of
plerixafor during the mobilization period will be recorded.
* Any SAE that occurs after the 30-day follow-up period that comes to the
attention of the site staff that may be causally related to study drug must be
reported to the Sponsor regardless of time elapsed.
* Any grade 3 and 4, study drug related AE or any SAE is to be followed until
resolution, return to baseline, or until mutually agreed upon by both the
Investigator and the Sponsor*s safety physician to discontinue.
* Disease progression, graft failure and/or death will be reported as SAEs for
up to 12 months post transplant.
Secondary outcome
Efficacy:
* Number of days to neutrophil engraftment and platelet engraftment
* Increase in number of circulating CD34+ cells from time 0 to 10-11 hours
after the first dose of plerixafor
* Total number of CD34+ cells collected by disease type
* Total number of CD34+ cells collected per apheresis day
* Graft status (as measured by trilineage counts and supportive treatment,
e.g., transfusion, G-CSF) at 100 days, 6 months, and 12 months following
transplant
The statistical analysis plan will provide the details on any additional
analyses, e.g., the proportion of patients achieving at least 5 × 106 CD34+
cells.
Background summary
Using plerixafor together with G-CSF for the mobilization of stem cells, might
enhance the mobilization of stem cells. This potentially enables collection of
a sufficient amount of stem cells for tranplantation within less apheresis
procedures.
This indicates for the patient that less apheresis days (days in the hospital)
are needed to collect more cells.
Plerixafor could also increase the predictability of succesfull timing of the
mobilization and collection of stem cells. This indicates that the autologous
transplantations could be scheduled more efficient which would optimize the
logistical planning within an institute.
Study objective
Primary Objective:
* To confirm the safety profile of plerixafor to mobilise stem cells when used
in patients with lymphoma or MM who are eligible to undergo treatment with an
autologous haematopoietic stem cell transplant
Secondary Objectives:
* To assess efficacy of plerixafor and granulocyte-colony stimulating factor
(G-CSF) as a mobilisation regimen as measured by the number of CD34+ cells
collected in each apheresis session
* To assess the clinical effectiveness of plerixafor and G-CSF mobilised stem
cells by examining haematopoietic cell engraftment and graft status
* To examine the influence of CD34+ cell dose infused on time to engraftment,
engraftment and graft status
Study design
This is a multi-centre, open label, single-arm study.
Plerixafor (240 mcg/kg) and G-CSF (10 mcg/kg/day, non-pegylated form) will be
administered subcutaneously (SC) to the patients.
Day 1-4: G-CSF (10 mcg/kg/day) will be administered for 4 consecutive days in
the morning.
Day 4: The plerixafor dose (240 mcg/kg) will be timed to allow for a 10- to
11-hour interval between the plerixafor dosing and the initiation of
apheresis.
Day 5: Patients will receive a morning dose of G-CSF (10 mcg/kg) approximately
1 hour prior to apheresis.
Patients may continue to receive the evening dose of plerixafor then G-CSF the
next morning followed by apheresis for up to a total of 5 apheresis procedures.
Prior to the first administration of plerixafor (on Day 4) and prior to
administration of G-CSF for the first day of apheresis (on Day 5), the patient
will have peripheral blood samples collected for determining the number of
CD34+ cells in the peripheral blood. In addition, a sample will be obtained
from each apheresis product to determine the quantity of CD34+ cells collected
after each procedure.
Following the last apheresis, patients will undergo pre-transplant
myeloablative chemotherapy followed by transplantation of the collected
autologous stem cells, using the established protocols and procedures at each
site. Subsequently, the patients will be monitored for graft status at 100
days, 6 months, and 12 months.
Intervention
Day 1-4: G-CSF 10 mcg/kg/day SC (non-pegylated form) will be administered in
the morning.
Day 4: The plerixafor dose 240 mcg/kg SC will be timed to allow for a 10- to
11-hour interval between the plerixafor dosing and the initiation of
apheresis.
Day 5: Patients will receive a morning dose of G-CSF (10 mcg/kg) SC
approximately 1 hour prior to apheresis.
Study burden and risks
Please refer to section E for the nature and extent of the burden and risks
associated with participation, benefit and grooup relatedness.
Gooimeer 10
1411 DD Naarden
Nederland
Gooimeer 10
1411 DD Naarden
Nederland
Listed location countries
Age
Inclusion criteria
1.Diagnosis of MM, NHL, or HD in partial response (PR) or complete response (CR)
2.Eligible and planned for an autologous haematopoietic stem cell transplantation
4.At least 18 years of age (inclusive)
Exclusion criteria
1. History of any acute or chronic leukaemia (including myelodysplastic syndrome)
2. Prior allogeneic transplantation or more than one prior autologous transplantation
3. Failed previous CD34+ cell collection attempts (either due to insufficient yield in apheresis product, or ineligible for apheresis because of inadequate mobilisation of CD34+ cells into peripheral blood)
4. Less than 4 weeks since last anti-cancer therapy (including chemotherapy, biologic/immunologic, radiation) or less than 6 weeks if prior therapy with nitrosourea or mitomycin (for therapies with long-acting agents, a treatment-free interval of at least 2 half-lives should be considered) with the exception of
- Treatment with thalidomide, dexamethasone, lenalidomide (Revlimid*), and/or bortezomib (Velcade*) which is allowed up to 7 days prior to the first dose of G-CSF.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-000689-21-NL |
| CCMO | NL23836.029.08 |