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CD34+ Selected ASCT for Aggressive Lymphomas

NCT02646098 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-07-08

No results posted yet for this study

Summary

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.

Conditions

  • Malignant Non-Hodgkin Lymphomas

Interventions

PROCEDURE

CD34+ cell selection

CD34+ cell selection applying a CliniMACS device (Miltenyi Biotec, Bergisch Gladbach, Germany). This method for CD34+ cell selection will be used in this study and is considered as the standard treatment.

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Thomas Pabst, Prof · Department for Medical Oncology; University Hospital/Inselspital; Freiburgstrasse 10; 3010 Bern

  • Gabriela Baerlocher, Prof · Universitätsklinik für Hämatologie und Hämatologisches Zentrallabor, Universitätsspital/Inselspital, 3010 Bern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-02
Primary Completion
2018-10-11
Completion
2023-11-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02646098 on ClinicalTrials.gov