NCT02646098Befejeződött2. fázis
CD34+ Selected ASCT for Aggressive Lymphomas
CD34+ Selected Versus Unselected Autologous Stem Cell Transplantation in Advanced Stage Mantle Cell and Diffuse Large B-cell Lymphoma Patients, a Randomized Phase II Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2024. júl. 8.
Rövid összefoglaló (regiszter, angolul)
Primary objective: To assess the differences in the overall survival at 3 years of a CD34+ cell selection versus no selection of hematopoietic progenitor cells harvested during peripheral blood stem cell collection before high-dose chemotherapy with autologous stem cell transplantation (ASCT) in advanced stage mantle cell lymphoma (MCL) or diffuse large B-cell lymphoma (DLBCL) patients. Secondary objectives: To assess differences in disease-free survival between CD34+ cell selection versus no selection of hematopoietic progenitor cells harvested during peripheral blood stem cell collection before high-dose chemotherapy with autologous stem cell transplantation (ASCT) in advanced stage mantle cell (MCL) or in diffuse large B-cell lymphoma (DLBCL) patients. To compare hematologic engraftment and the time needed until hematologic recovery after ASCT using CD34+ selected or unselected autologous stem cell grafts. To compare infectious complications, particularly CMV infections, observed until 100 days after ASCT comparing CD34+ selected or unselected autologous stem cell grafts. To assess the response rate at day 100 after ASCT in advanced stage mantle cell lymphoma (MCL) or diffuse large B-cell lymphoma (DLBCL) patients after ASCT comparing patients with CD34+ cell selection versus no selection. To assess the total time needed for the apheresis procedure and the number of apheresis days needed to ensure the collection of a sufficient number of autologous stem cells comparing patients with CD34+ cell selection versus no selection. To assess the need for the additional use of G-CSF (Neupogen) and of the stem cell releasing compound Plerixafor (Mozobil) to ensure the collection of a sufficient number of autologous stem cells comparing patients with CD34+ cell selection versus no selection. Outcome(s): The aim of the study is to show ≥ 15% better 3-year overall survival of lymphoma patients having received CD34+ cell selection during autologous stem cell collection before autologous stem cell transplantation compared to no CD34+ cell selection.
- Állapot (regiszter)
- Befejeződött
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 64 (tényleges)
- Első benyújtás
- 2015. nov. 4.
- Kezdés
- 2015. nov. 2.
- Elsődleges befejezés
- 2018. okt. 11.
- Fő szponzor
- Insel Gruppe AG, University Hospital Bern
- NCT-szám
- NCT02646098
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Bevont résztvevők: 64
- 2015. nov. 2. és az elsődleges befejezés (2018. okt. 11.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Patients not fit for autologous stem cell transplantation (ASCT).
- Previous or concurrent malignant disease with the exception of basalioma/spinalioma of the skin, early-stage cervix carcinoma, or early-stage prostate cancer.
- Major surgery less than 30 days before start of treatment.
Más betegség
- Patients with other serious medical condition that interfere with the completion of treatment according to this protocol or that would impair tolerance to therapy or prolong hematological recovery. Noteworthy, patients with seropositivity for HIV or for Hepatitis B and C are not excluded from this study if they are otherwise considered fit for ASCT.
- Acute uncontrolled infection
- Relevant co-existing disease excluding a treatment according to protocol
- Major coagulopathy or bleeding disorder.
Egyéb
- HCTCI > 10
- Lack of patient cooperation to allow study treatment as outlined in this protocol.
- Pregnant or lactating female patients.
Kiket keres a vizsgálat
- Eligible are patients with advanced stage (stage III or IV) malignant lymphomas including mantle cell lymphoma (MCL) in first or second remission or patients with diffuse large B-cell lymphoma (DLBCL) in first or second remission planned to undergo subsequent consolidation with standard high-dose chemotherapy with autologous stem cell transplantation.
- Patients must be aged 18-75 years, and must have given voluntary written informed consent.
- Negative pregnancy test (urine or serum) within 14 days prior to registration for all women of childbearing potential. Patients of childbearing potential must implement adequate measures (hormonal treatment p.o. or i.m., intra uterine surgical devices, or latex condoms) to avoid pregnancy during study treatment and for additional 12 months. No pregnant or lactating patients are allowed.
Életkor a regiszterben: 18 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Department for Medical Oncology University Hospital/Inselspital | Bern | Svájc | Ismeretlen állapot |
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