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Chemotherapy

Stem Cell Transplant + NK DLI for Blood Cancer

Phase 1

Waitlist Available

Led By Noah Merin, MD, PhD

Research Sponsored by Noah Merin

Eligibility Criteria Checklist

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

Must have

Patients with aggressive lymphomas requiring partial or complete remission (PR or CR) prior to alloHSCT

Patient age 18 - 75 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 365 days

Awards & highlights

Study Summary

This trial is testing a new way to do a stem cell transplant for blood cancer using a less intense conditioning regimen and adding CD56-enriched Donor Lymphocyte Infusion.

Who is the study for?

This trial is for adults aged 18-75 with certain types of blood cancers like CLL, multiple myeloma, and various lymphomas. Participants must have a related donor who's at least half-matched (haploidentical), be in a specific health condition (ECOG 0 - 2), and not pregnant or without proper contraception. It excludes those with fully matched sibling donors under age 55, significant heart/lung/liver/kidney issues, uncontrolled infections, or unable to consent.Check my eligibility

What is being tested?

The study tests a conditioning regimen including bendamustine, fludarabine, rituximab before haploidentical stem cell transplant plus post-transplant cyclophosphamide. Additionally, it investigates CD56-enriched Donor Lymphocyte Infusion's safety and effectiveness in improving outcomes and reducing Graft-Versus-Host Disease risk after the transplant.See study design

What are the potential side effects?

Potential side effects include reactions to medications like rituximab (infusion reactions), complications from chemotherapy (nausea, fatigue), risks associated with stem cell transplantation such as infection or graft failure, and possible development of Graft-Versus-Host Disease where the new cells attack the patient’s body.

Eligibility Criteria

Inclusion Criteria

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

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I need a stem cell transplant and my aggressive lymphoma is partially or completely in remission.

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I am between 18 and 75 years old.

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I have a diagnosis of a resistant or relapsed type of lymphoma.

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I have aggressive lymphoma (Mantle Cell or Diffuse Large B Cell).

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I can take care of myself and am up and about more than half of the day.

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I have a donor who is a genetic match or at least half-matched to me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 365 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~365 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 365 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Rate of Survival at 30 days post -transplantation

Secondary outcome measures

Rate of neutrophil engraftment at 30 days

Rate of platelet recovery at 100 days post-transplantation

Rate of severe chronic GVHD at 365 days post-transplantation

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SubjectsExperimental Treatment6 Interventions

Pre-Transplantation Conditioning (Bendamustine, Fludarabine, and Rituximab + Total Body Irradiation) + Haploidentical Stem Cell Transplantation with CD56-enriched donor lymphocyte infusion

Group II: ControlsActive Control1 Intervention

Patients undergoing standard-of-care reduced-intensity peripheral blood allogeneic stem cell transplantation (any indication, donor source, conditioning regimen) using PTCy GVHD prophylaxis.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 3

~1100

Rituximab

1999

Completed Phase 4

~1880

Bendamustine

2015

Completed Phase 3

~2950

Haploidentical Stem Cell Transplantation

2014

Completed Phase 3

~10

Total Body Irradiation

2006

Completed Phase 3

~820

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Miltenyi Biomedicine GmbHIndustry Sponsor

33 Previous Clinical Trials

1,593 Total Patients Enrolled

6 Trials studying Lymphoma

471 Patients Enrolled for Lymphoma

Noah MerinLead Sponsor

1 Previous Clinical Trials

6 Total Patients Enrolled

Teva Branded Pharmaceutical Products R&D, Inc.Industry Sponsor

251 Previous Clinical Trials

3,485,346 Total Patients Enrolled

3 Trials studying Lymphoma

650 Patients Enrolled for Lymphoma

Media Library

Bendamustine (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03524235 — Phase 1

Lymphoma Research Study Groups: Controls, Subjects

Lymphoma Clinical Trial 2023: Bendamustine Highlights & Side Effects. Trial Name: NCT03524235 — Phase 1

Bendamustine (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03524235 — Phase 1

Frequently Asked Questions

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

What is the current sample size of this experiment?

"Regrettably, this trial is not presently seeking candidates. The study was initially shared on the 18th of July 2018 and last refreshed on August 31st 2022. If you are searching for other trials, there are 2560 studies actively recruiting patients with multiple myeloma and 771 clinical trials related to Haploidentical Stem Cell Transplantation that accept participants."

Answered by AI

What are the associated risks of Haploidentical Stem Cell Transplantation?

"Haploidentical Stem Cell Transplantation is still in a Phase 1 trial, signifying that there is limited evidence for both its safety and efficacy. Thus, we have assessed the risk at Power to be a score of 1."

Answered by AI

What pathologies have been seen to benefit from Haploidentical Stem Cell Transplantation?

"Haploidentical Stem Cell Transplantation is a common intervention for dlbcl, but it has been prescribed to tackle diverse conditions such as hodgkin disease, b-cell lymphomas, and polyangium."

Answered by AI

Is participation in this experiment an option for me?

"This trial is currently recruiting 30 participants between the ages of 18 and 75 years old who have been diagnosed with multiple myeloma. To be eligible, patients must also meet a variety of criteria including: having an ECOG score between 0-2; possessing no history of AIDS defining conditions or opportunistic infections (except for past low CD4+ cell counts); being on antiretroviral therapy that has led to undetectable viral load; not possessing any drugs or therapies in their system which may interact adversely with tacrolimus; and either holding a related donor, at minimum HLA haploidentical, meeting 5/"

Answered by AI

Is the minimum age requirement for this research project 18 years or older?

"The trial's parameters for enrollment state that minors under 18 years of age are not eligible, whereas those who have reached their 75th birthday may be considered."

Answered by AI

Are there still openings for participants in this experiment?

"This research initiative has now closed its recruitment process. It was first posted on July 18th 2018, and the last update occurred August 31st 2022. For those seeking alternate studies, there are currently 2560 medical trials for multiple myeloma and 771 clinical tests focusing on Haploidentical Stem Cell Transplantation actively enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Haploidentical Stem Cell Transplant With Prophylactic Natural Killer DLI for Lymphoma, Multiple Myeloma, and CLL

Noah Merin 2018. "Haploidentical Stem Cell Transplant With Prophylactic Natural Killer DLI for Lymphoma, Multiple Myeloma, and CLL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03524235.

All > Multiple Myeloma > Lymphoma