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Immunosuppressant

Stem Cell Transplant for Blood Cancers

Phase 2
Waitlist Available
Led By Brian Shaffer, 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
Cardiac left ventricular ejection fraction ≥50% at rest
Karnofsky/Lanksy performance status ≥70%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing a new way to stop the donor's immune system from attacking the patient's body.

Who is the study for?
This trial is for patients with various high-risk blood cancers, including different types of leukemia and lymphoma. Eligible participants are those from birth to 65 years old with a good performance status, adequate organ function, and no HIV or active infections. Pregnant or breastfeeding women can't join, nor can those with matched sibling donors.Check my eligibility
What is being tested?
The study tests a new method to prevent rejection in stem cell transplantation from mismatched donors using treatments like irradiation and chemotherapy before the transplant. It aims to see if this approach is effective in patients who have high-risk features or have not responded well to other treatments.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's response such as graft-versus-host disease, infection risks due to weakened immunity post-transplant, organ damage from chemotherapy and radiation therapy, fatigue, nausea, and potential complications from the transplant procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart pumps well, with an ejection fraction of 50% or higher.
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I am mostly able to care for myself.
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My lung function test shows at least half the expected value for someone my age and size.
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I have a blood cancer suitable for a stem cell transplant.
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I am between the ages of 0 and 65.
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My kidneys are functioning well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
the number of incidences of grade 3-4 acute GVHD

Trial Design

3Treatment groups
Experimental Treatment
Group I: Radiation, Thiotepa & CyclophosphamideExperimental Treatment6 Interventions
Group II: Clofarabine, Thiotepa & MelphalanExperimental Treatment6 Interventions
Group III: Busulfan, Fludarabine & MelphalanExperimental Treatment6 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Thiotepa
2008
Completed Phase 3
~2150
Melphalan
2008
Completed Phase 3
~1500
Cyclophosphamide
1995
Completed Phase 3
~3770
Busulfan
2008
Completed Phase 3
~1120
Rituximab
1999
Completed Phase 4
~1880
Clofarabine
2007
Completed Phase 3
~1130
Fludarabine
2012
Completed Phase 3
~1100

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,613 Total Patients Enrolled
Brian Shaffer, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
48 Total Patients Enrolled

Media Library

Busulfan (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT03615105 — Phase 2
Non-Hodgkin's Lymphoma Research Study Groups: Radiation, Thiotepa & Cyclophosphamide, Busulfan, Fludarabine & Melphalan, Clofarabine, Thiotepa & Melphalan
Non-Hodgkin's Lymphoma Clinical Trial 2023: Busulfan Highlights & Side Effects. Trial Name: NCT03615105 — Phase 2
Busulfan (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03615105 — Phase 2

Frequently Asked Questions

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

Could you please describe the side effects of Melphalan?

"Melphalan's safety protocols merit a score of 2 because, while there is some evidence backing its safety, none exists yet to support efficacy."

Answered by AI

What is Melphalan most commonly used to treat?

"Melphalan is a medication most often used to treat lung cancers, but it can also be effective in treating b-cell lymphomas, polyangium, and multiple sclerosis."

Answered by AI

Is Melphalan a common medication used in clinical trials?

"There are 1284 ongoing clinical trials related to Melphalan, with 238 of them being in Phase 3. Most investigations for Melphalan are based in Philadelphia, Pennsylvania; though, there 38467 locations worldwide where studies for Melphalan are conducted."

Answered by AI

Is there still room for more people in this clinical trial?

"This particular study is no longer recruiting patients, as the last edit was on 8/18/2022. However, there are 3137 clinical trials currently underway for leukemia, lymphocytic, acute, l1 and 1284 studies involving Melphalan that are still looking for participants."

Answered by AI

How many individuals are under observation in this clinical trial?

"This study has already completed recruitment for participants. The study was first posted on July 25th, 2018 and updated as recently as August 18th, 2022. Currently, there are 3137 trials actively searching for leukemia patients and 1284 Melphalan trials with open enrollment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Donor Stem Cell Transplantation Using α/β+ T-lymphocyte Depleted Grafts From HLA Mismatched Donors
2018. "Donor Stem Cell Transplantation Using α/β+ T-lymphocyte Depleted Grafts From HLA Mismatched Donors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03615105.
~1 spots leftby Apr 2025
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