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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

Must not have

Patients with a readily-available, suitable, fully-matched sibling donor (MRD) less than age 55

Women of childbearing potential who currently are pregnant or who are not practicing adequate contraception

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 365 days

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a sibling under 55 who is a perfect match for a donation.

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I am a woman who could get pregnant and am not using effective birth control or am currently pregnant.

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My cancer has spread to my brain and is not under control.

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I do not have any untreated infections.

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My heart does not work well.

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My kidneys do not work well.

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I have breathing problems or my lung function is not good.

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My liver isn't working well.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of Survival at 30 days post -transplantation

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Total Body Irradiation

2006

Completed Phase 3

~820

Haploidentical Stem Cell Transplantation

2014

Completed Phase 3

~30