Malignant Lymphoma Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03346096 -
TEAM (Thiotepa, Etoposide, Cytosar, Melphalan ) for AutoSCT in Lymphoma
|
Phase 2 | |
| Completed |
NCT05190263 -
Quality Assurance on Anemia Management in Patients With Solid Tumors and Malignant Lymphoma
|
||
| Completed |
NCT01473095 -
Phase 1 Dose Escalation Study of ARQ 092 in Adult Subjects With Advanced Solid Tumors and Recurrent Malignant Lymphoma
|
Phase 1 | |
| Completed |
NCT00683046 -
T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies
|
Phase 2 | |
| Recruiting |
NCT02131688 -
Phase I Study of Mitoxantrone Hydrochloride Liposome Injection
|
Phase 1 | |
| Completed |
NCT00892502 -
Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy?
|
N/A | |
| Completed |
NCT00685997 -
Whole-body Magnetic Resonance Imaging (MRI) for Staging Malignant Lymphomas
|
N/A | |
| Not yet recruiting |
NCT06358001 -
EchoTip AcuCore Post-Market Clinical Study
|
||
| Recruiting |
NCT04986293 -
CPAP or BiPAP for Motion Mitigation During Radiotherapy
|
N/A | |
| Completed |
NCT01588548 -
Global Phase1 Study to Assess the Safety and Tolerability of AZD1208 in Advanced Solid Tumors and Malignant Lymphoma
|
Phase 1 | |
| Withdrawn |
NCT04464889 -
HA-1H TCR T Cell for Relapsed/Persistent Hematologic Malignancies After Allogeneic Stem Cell Transplantation
|
Phase 1 | |
| Completed |
NCT03316144 -
Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of Toripalimab for Patients With Recurrent Malignant Lymphoma
|
Phase 1 | |
| Completed |
NCT04464590 -
Interest of a Systematic One-year Monitoring by 18F-FDG PET-CT
|
||
| Recruiting |
NCT04698616 -
Lean Body Mass and Side Effects in Patients With Lymphoma
|
||
| Active, not recruiting |
NCT02678299 -
Phase 1/2 Study of the Combination of Pixantrone, Etoposide, Bendamustine and, in CD20 Positive Tumors, Rituximab in Patients With Relapsed Aggressive Non-Hodgkin Lymphomas of B- or T-cell Phenotype - the P[R]EBEN Study
|
Phase 1/Phase 2 | |
| Completed |
NCT01499147 -
Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies
|
N/A | |
| Completed |
NCT01789060 -
p-AKT Expression on Clinical Outcomes in Malignant Lymphoma
|
N/A | |
| Completed |
NCT05827341 -
A Real-World Study of COVID-19 Infection in Patients With Malignant Lymphomas Participating in Clinical Trials
|
||
| Active, not recruiting |
NCT05515029 -
Preventing of GVHD With Post-transplantation Cyclophosphamide, Abatacept, Vedolizumab and Calcineurin Inhibitor at Patients With Hemoblastosis
|
Phase 3 | |
| Not yet recruiting |
NCT05545202 -
A Randomized, Comparative, Double-blind Trial of Pentaisomaltose and Dimethyl Sulphoxide for Cryoprotection of Hematopoietic Stem Cells in Subjects With Multiple Myeloma or Malignant Lymphoma With a Need for Autologous Transplantation
|
Phase 4 |