Phase 3
Completed N=122
Two Different Methods of Collecting Stem Cells For an Autologous Stem Cell Transplant in Treating Patients With Diffuse Large Cell Lymphoma
Source: ClinicalTrials.gov NCT00566228 ↗Enrolled (actual)
122
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcomePrimary: Median Progression-free Survival — NA; NA months — p=0.690
◆ Published Evidence
Established
26citations · ~3 / year
Immunologic Autograft Engineering and Survival in Non-Hodgkin Lymphoma.
Summary
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.
Linked Publications (2)
-
Immunologic Autograft Engineering and Survival in Non-Hodgkin Lymphoma.
-
Autograft immune content and survival in non-Hodgkin's lymphoma: A post hoc analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Progression-free Survival |
NA; NA | 0.690 |
| SECONDARY Progression-free Survival Rate at 1 Year |
73.1; 65.4 | — |
| SECONDARY Progression-free Survival Rate at 2 Years |
57.9; 65.4 | — |
| SECONDARY One-year Overall Survival Rate |
91.1; 83.6 | 0.679 |
| SECONDARY Median Time to Absolute Lymphocyte Count Engraftment |
14; 14 | — |
| SECONDARY Median Number of CD34 Cells/kg Infused |
4.6; 5.3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00566228) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.