Clinical trial · Interventional
Two Different Methods of Collecting Stem Cells For an Autologous Stem Cell Transplant in Treating Patients With Diffuse Large Cell Lymphoma
Randomized, Double-Blind Phase III Clinical Trial Comparing Outcomes of Immunologic Autograft Engineering Versus Standard Autograft Collection in Patients Undergoing Autologous Stem Cell Transplantation for Lymphoma
NCT00566228CI-TRIAL-00033674completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: It is not yet known which method of stem cell collection is best for patients undergoing an autologous stem cell transplant. PURPOSE: This randomized phase III trial is comparing two different methods of collecting stem cells in patients undergoing stem cell transplant for diffuse large cell lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| leukapheresis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Immunologic autograft engineering
- description
- Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0). Patients undergo ASCT IV on the day of apheresis (lymphocyte enriched autograft).
- interventionNames
- Procedure: autologous hematopoietic stem cell transplantation
- Procedure: leukapheresis
- type
- ACTIVE_COMPARATOR
- label
- Standard autograft collection
- description
- Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0). Patients undergo ASCT IV on the day of apheresis.
- interventionNames
- Procedure: autologous hematopoietic stem cell transplantation
- Procedure: leukapheresis
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of diffuse large cell lymphoma * Low-grade non-Hodgkin lymphoma transformed to diffuse large cell lymphoma allowed * Candidate for with autologous peripheral blood stem cell transplantation * Not requiring bone marrow harvest to collect stem cells * No chemotherapy with filgrastim ( G-CSF) or mobilization study drug (i.e., AMD3100) needed for mobilization of stem cells PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Cardiac and pulmonary status sufficient to undergo apheresis and stem cell transplantation * Negative pregnancy test * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative * No active uncontrolled infection requiring antibiotic treatment * No comorbid condition which, in view of the investigators, renders the patient at high risk from treatment complications * Willing to provide all research blood samples as required by the protocol PRIOR CONCURRENT THERAPY: * At least 4 weeks since prior chemotherapy (rituxan is not considered chemotherapy for the purpose of this study) * More than 4 weeks since prior experimental therapy * No concurrent enrollment on another experimental protocol during the mobilization phase * No concurrent participation in any autologous stem cell transplantation study that is not using the standard conditioning regimens for lymphomas
References
Publications (2)
- RESULTPorrata LF, Burgstaler EA, Winters JL, Jacob EK, Gastineau DA, Suman VJ, Inwards DJ, Ansell SM, Micallef IN, Johnston PB, Nevala W, Markovic SN. Immunologic Autograft Engineering and Survival in Non-Hodgkin Lymphoma. Biol Blood Marrow Transplant. 2016 Jun;22(6):1017-1023. doi: 10.1016/j.bbmt.2016.01.024. Epub 2016 Jan 27. PMID 26826432
- DERIVEDPorrata LF, Inwards DJ, Ansell SM, Micallef IN, Johnston PB, Villasboas JC, Markovic SN. Autograft immune content and survival in non-Hodgkin's lymphoma: A post hoc analysis. Leuk Res. 2019 Jun;81:1-9. doi: 10.1016/j.leukres.2019.03.009. Epub 2019 Apr 4. PMID 30978434