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Stem Cell Transplantation

High-Dose Therapy and Autologous Stem Cell Transplant for Non-Hodgkin's Lymphoma

Phase 2

Waitlist Available

Led By Craig Sauter, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eligible for high-dose therapy and autologous stem-cell rescue

Complete or partial response by IWG Working Group or ICML Criteria to maximum of one salvage line of chemotherapy without pre-HDT/ASCT salvage radiotherapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 15

Awards & highlights

Study Summary

This trial will help researchers learn if giving more stem cells during transplant helps people with cancer.

Who is the study for?

Adults over 18 with relapsed or refractory DLBCL who've had one prior anthracycline-based chemotherapy can join. They should be fairly fit (KPS ≥ 70), have decent kidney function, and not too high bilirubin levels in the blood. Women and men must use birth control, and they shouldn't have HIV or other conditions that would interfere with stem cell procedures.Check my eligibility

What is being tested?

The trial is examining how different doses of CD34+ stem cells affect recovery after a high-dose therapy followed by an autologous stem cell transplant in patients with certain types of B-cell lymphoma.See study design

What are the potential side effects?

Potential side effects include reactions to medications like carmustine, etoposide, cytarabine, melphalan; complications from Plerixafor; issues related to leukapheresis; and risks associated with autologous stem cell transplantation such as infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am eligible for a treatment involving high-dose therapy and my own stem cells.

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I've had a good response to one round of chemotherapy without prior high-dose therapy or stem cell transplant.

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My total bilirubin is over 2.0 mg/dL, but my direct bilirubin is under 2.0 mg/dL.

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My kidney function, measured by creatinine levels or clearance, is within the required range.

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My lymphoma returned or didn't respond after one treatment with anthracycline.

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I am mostly able to care for myself.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 15

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 15

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 15 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

progression-free survival (PFS)

Secondary outcome measures

the impact of CD34+ cell dose on lymphocyte subset recovery

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 6-8 x10^6 CD34+ stem cells/kgExperimental Treatment4 Interventions

Patients will receive standard supportive measures (including: growth factor support post-HDT/ASCT, antimicrobial prophylaxis, red blood cell and platelet transfusion and treatment for neutropenic fever) as per institutional guideline practices.

Group II: 3-4 x 10^6 CD34+ stem cells/kgActive Control4 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Plerixafor

2011

Completed Phase 3

~720

Autologous Stem Cell Transplantation

2012

Completed Phase 3

~1000

leukapheresis

2004

Completed Phase 3

~230

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cleveland ClinicOTHER

1,026 Previous Clinical Trials

1,366,017 Total Patients Enrolled

Medical College of WisconsinOTHER

609 Previous Clinical Trials

1,162,542 Total Patients Enrolled

NorthShore University HealthSystemOTHER

132 Previous Clinical Trials

737,801 Total Patients Enrolled

Media Library

Autologous Stem Cell Transplantation (Stem Cell Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT02570542 — Phase 2

Non-Hodgkin's Lymphoma Research Study Groups: 6-8 x10^6 CD34+ stem cells/kg, 3-4 x 10^6 CD34+ stem cells/kg

Non-Hodgkin's Lymphoma Clinical Trial 2023: Autologous Stem Cell Transplantation Highlights & Side Effects. Trial Name: NCT02570542 — Phase 2

Autologous Stem Cell Transplantation (Stem Cell Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02570542 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How widely is this research endeavor being conducted in the metropolitan area?

"Memorial Sloan Kettering Monmouth (Consent and Follow up Only) in Middletown, Tennessee, Tennessee Oncology in Nashville, New york, Northwell Health in Manhasset Texas are available to recruit patients for this trial. In addition 14 other medical centres across the nation have been selected."

Answered by AI

To what extent has this experiment been populated by participants?

"This medical trial is no longer open for enrollment. It was initially published on October 1st 2015 and received its last update on the 28th of October 2022. However, if one wishes to join a clinical study, there are 1766 active trials related to lymphoma (large b-cell diffuse) as well as 583 ongoing studies concerning Autologous Stem Cell Transplantation that still need participants."

Answered by AI

Are there any precedents of Autologous Stem Cell Transplantation within a clinical trial context?

"In 1997, Autologous Stem Cell Transplantation was initially investigated at City of Hope Comprehensive Cancer Center. Since then, 988 clinical trials have been concluded and 583 are still in progress; many of which take place in Middletown, Tennessee."

Answered by AI

What therapeutic applications is Autologous Stem Cell Transplantation commonly employed for?

"Autologous Stem Cell Transplantation is an effective therapeutic approach for treating hematopoietic stem cells, merkel cell cancer, and meningeal leukemia."

Answered by AI

Does Autologous Stem Cell Transplantation pose any potential risks to those undergoing the procedure?

"There is some evidence of safety for Autologous Stem Cell Transplantation, but no clinical data to suggest efficacy, resulting in a score of 2."

Answered by AI

Are researchers seeking volunteers for this experiment at present?

"As indicated on clinicaltrials.gov, this investigation is not currently accepting participants; the first post being made in October 2015 and the latest update occurring on 28th of October 2022. Although recruitment has ceased for this trial, there are 2,349 other medical studies searching for volunteers right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of the Impact of CD34+ Cell Dose on Absolute Lymphocyte Count Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)

2015. "Study of the Impact of CD34+ Cell Dose on Absolute Lymphocyte Count Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02570542.

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