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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-transplant through study completion or death, assessed up to 3 years post-transplant for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

100-Day Survival

Secondary outcome measures

Immune Checkpoint Regulators - Function

Immune Checkpoint Regulators - Incidence

Immune Checkpoint Regulators - Prevalence

+4 more

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

Tacrolimus

FDA approved

Cyclophosphamide

FDA approved

Fludarabine

FDA approved

Total Body Irradiation

2006

Completed Phase 3

~820

Mycophenolate mofetil

FDA approved

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor

526 Previous Clinical Trials

2,541,242 Total Patients Enrolled

11 Trials studying Leukemia

357 Patients Enrolled for Leukemia

Kenneth Meehan, MDPrincipal Investigator - Dartmouth-Hitchcock Medical Center

Children's Hospital at Dartmouth, Dartmouth-Hitchcock Medical Center, Mary Hitchcock Memorial Hospital

Georgetown University School Of Medicine (Medical School)

Georgetown University Medical Center (Residency)

4 Previous Clinical Trials

130 Total Patients Enrolled

1 Trials studying Leukemia

20 Patients Enrolled for Leukemia

Frequently Asked Questions

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

To be eligible for this trial, what are the requirements for participants?

"This study is looking for 20 individuals that have lymphoma and meet the following qualifications: being between 18 and 75 years old, having a related haplo-identical donor, being negative for HIV/AIDS and active hepatitis, being approved for transplant by a physician, and having acute leukemia, chronic leukemia, myelodysplasia, myeloproliferative disorder, myelofibrosis, non-Hodgkin's lymphoma or Hodgkin's disease, plasma cell disorder, or Waldenstrom's macroglobulinemia."

Answered by AI

What is the maximum patient enrollment for this trial?

"Yes, the data on clinicaltrials.gov says that this study is currently searching for candidates. The trial was initially posted on 3/28/2018 and was last edited on 4/29/2021. The trial is enrolling 20 participants across 1 site."

Answered by AI

Does this experiment involve any participants over the age of seventy-five?

"This particular trial is for adults aged 18 to 75. There are 1268 other trials for people under 18 and 4222 for those over 65."

Answered by AI

What is the primary disease that this medication is used to treat?

"This treatment is effective for bone marrow transplantation, leukemia, and infection."

Answered by AI

Will this treatment have any negative side effects for patients?

"The safety of this medical intervention falls on the third tier of our team's 1-3 scale. This is a Phase 3 trial, signifying that while there is data supporting both safety and efficacy, further rounds of testing are needed."

Answered by AI

Are there other examples of this therapy being tested in a scientific setting?

"There are 1112 studies being conducted globally on this treatment, with 202 of them being Phase 3 clinical trials. Most of these studies are based in Philadelphia, but there are 30986 locations running trials for this treatment."

Answered by AI

Recent research and studies

BloodJournal

Hematopoietic Stem Cell Transplantation Donor Sources in the 21st Century: Choosing the Ideal Donor When a Perfect Match Does Not Exist

Kekre, Natasha, and Joseph H. Antin. 2014. “Hematopoietic Stem Cell Transplantation Donor Sources in the 21st Century: Choosing the Ideal Donor When a Perfect Match Does Not Exist”. Blood. American Society of Hematology. doi:10.1182/blood-2014-02-514760.

Biology of Blood and Marrow TransplantationJournal

Progress in Haploidentical Stem Cell Transplantation

Bayraktar, Ulas D., Richard E. Champlin, and Stefan O. Ciurea. 2012. “Progress in Haploidentical Stem Cell Transplantation”. Biology of Blood and Marrow Transplantation. Elsevier BV. doi:10.1016/j.bbmt.2011.08.001.

Advances in HematologyJournal

Haploidentical Stem Cell Transplantation in Adult Haematological Malignancies

Parmesar, Kevon, and Kavita Raj. 2016. “Haploidentical Stem Cell Transplantation in Adult Haematological Malignancies”. Advances in Hematology. Hindawi Limited. doi:10.1155/2016/3905907.

Biology of Blood and Marrow TransplantationJournal