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Alkylating agents

Stem Cell Transplant for Leukemia

Phase 3

Waitlist Available

Led By Kenneth Meehan, MD

Research Sponsored by Dartmouth-Hitchcock Medical Center

Eligibility Criteria Checklist

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

Must have

No major organ dysfunction precluding transplantation

Patient must have an identified RELATED haplo-identical donor

Must not have

Major illness or organ failure incompatible with survival from transplant

History of refractory systemic infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-transplant through study completion or death, assessed up to 3 years post-transplant

Awards & highlights

Approved for 20 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

Pivotal Trial

Summary

This trial will use the standard Johns Hopkins' regimen with donor peripheral blood stem cells instead of marrow. Clinical outcomes will focus on immune reconstitution and immune checkpoint regulators after a related haploidentical stem cell transplant.

Who is the study for?

This trial is for people under 75 with certain blood cancers like various leukemias, lymphomas, and myeloma who might benefit from a stem cell transplant. They need to have a related donor that's a partial genetic match (haploidentical), be in decent physical shape without major organ failure or active infections, and not have HIV or hepatitis B/C.

What is being tested?

The study tests the standard Johns Hopkins' regimen using donor peripheral blood stem cells instead of marrow for transplants. It aims to observe clinical outcomes and how immune checkpoint regulators behave after the transplant in patients with specific blood disorders.

What are the potential side effects?

Potential side effects may include reactions to medications like Fludarabine and Cyclophosphamide such as nausea, fatigue, low blood counts; Tacrolimus can cause kidney issues; Total Body Irradiation may lead to mucositis; risk of graft-versus-host disease due to mismatched donor cells.

Eligibility Criteria

Inclusion Criteria

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

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My major organs are functioning well enough for a transplant.

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I have a family member who is a match for my transplant.

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I do not have HIV, hepatitis B, or hepatitis C.

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I do not have any ongoing or unmanageable infections.

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I am under 75 years old.

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My condition can improve with a stem cell transplant.

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My heart pumps blood effectively with at least 40% efficiency.

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I am not pregnant.

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I don't have any cancer that limits my life expectancy to under 2 years.

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I am able to get out of my bed or chair and move around.

Exclusion Criteria

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

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I do not have a major illness or organ failure that would prevent me from surviving a transplant.

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I have had infections that didn't respond to treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year post date of peripheral blood transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year post date of peripheral blood transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year post date of peripheral blood transplant for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants Who Achieved a Response to Treatment at 100 Days

Number of Participants Who Achieved a Response to Treatment at One Year

Number of Participants Who Experienced Donor-Recipient Chimerism Following Transplant at Days 30, 60, and 90.

+7 more

Secondary study objectives

Immune Checkpoint Regulators - Function

Immune Checkpoint Regulators - Incidence

Immune Checkpoint Regulators - Prevalence

+4 more

Awards & Highlights

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

No Placebo-Only Group

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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Johns Hopkins' conditioning regimenExperimental Treatment7 Interventions

Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

FDA approved

Fludarabine

FDA approved

Tacrolimus

FDA approved

Total Body Irradiation

2006