Two Different Methods of Collecting Stem Cells For an Autologous Stem Cell Transplant in Treating Patients With Diffuse Large Cell Lymphoma

NCT00566228 | Completed Phase 3 Results DMC

• 3 other identifiers: MC0681P30CA01508307-000789
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphoma

Keywords

noncontiguous stage II adult diffuse large cell lymphoma; stage III adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma; recurrent adult diffuse large cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Median Progression-free Survival

  Progression free survival (PFS) was defined as the time from the date of infusion to disease progression, relapse, or death from any cause. Patients alive without disease progression or relapse were censored at their last disease evaluation or at their secondary primary cancer diagnosis, whichever occurred first. Criteria for Relapsed Disease: Appearance of any new lesion or increase by ≥50% in the size of previously involved sites, ≥50% increase in greatest diameter of any previously identified node \>1.0 cm in its short axis or in the sum of the products of diameters (SPD) of more than one node. Criteria for Progressive Disease: ≥50% increase from nadir in the SPD of any previously identified abnormal node or ALC for partial remissions or non-responders, Appearance of any new lesion (≥ 2x2 cm). A log rank test was used to assess whether PFS differed with respect to apheresis collection method.

  Date of infusion to disease progression, relapse, or death from any cause whichever came first, assessed up to 24 months post enrollment.

Secondary Outcomes (5)

• Progression-free Survival Rate at 1 Year

  Date of infusion to disease progression, relapse, or death from any cause, up to one year

• Progression-free Survival Rate at 2 Years

  Date of infusion to disease progression, relapse, or death from any cause, up to two years

• One-year Overall Survival Rate

  date of infusion to death from any cause, up to one year

• Median Time to Absolute Lymphocyte Count Engraftment

  Up to 30 days after autologous peripheral hematopoietic stem cell transplantation

• Median Number of CD34 Cells/kg Infused

  5 to 7 days after patient received granulocyte-colony stimulating factor and reached a peripheral CD34 count of 10 cells/microliter or greater

Other Outcomes (1)

• Evaluation and Comparison of Immunologic Recovery Within and Between the Arms by Assessing the Quantitative and Functional Immune Effector Cells (T, B, or NK Cells) From the Apheresis Product

  Baseline

Study Arms (2)

Immunologic autograft engineering

EXPERIMENTAL

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).

Procedure: autologous hematopoietic stem cell transplantation; Procedure: leukapheresis

Standard autograft collection

ACTIVE COMPARATOR

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.

Procedure: autologous hematopoietic stem cell transplantation; Procedure: leukapheresis

Interventions

autologous hematopoietic stem cell transplantation PROCEDURE

Patients undergo autologous stem cell transplantation

Immunologic autograft engineering; Standard autograft collection

leukapheresis PROCEDURE

Stem cells collected

Immunologic autograft engineering; Standard autograft collection

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• Porrata 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 RESULT

• Porrata 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 DERIVED

MeSH Terms

Conditions

Lymphoma; Lymphoma, Large B-Cell, Diffuse

Interventions

Leukapheresis

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Cytapheresis; Biological Therapy; Therapeutics; Blood Component Removal; Leukocyte Reduction Procedures; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques

Results Point of Contact

• Title: Luis F. Porrata, M.D.
• Organization: Mayo Clinic

Porrata.Luis@mayo.edu

507/284-2511

Study Officials

• Luis F. Porrata, MD

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2007
• First Posted: December 3, 2007
• Study Start: December 1, 2007
• Primary Completion: January 15, 2015
• Study Completion: January 15, 2015
• Last Updated: July 9, 2018
• Results First Posted: July 9, 2018

Record last verified: 2018-06

Locations

US (1)