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Chemotherapy
Cord Blood Transplant for Blood Cancers
Phase 2
Recruiting
Led By Ioannis Politikos, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 45 post-transplant
Awards & highlights
Summary
This trial is studying how to make cord blood transplants more successful for adults with blood cancers.
Who is the study for?
This trial is for adults with various high-risk blood cancers, including different types of leukemia and lymphoma. Participants must meet specific criteria such as being in a certain phase of remission, having adequate organ function, and not having had certain previous treatments like stem cell transplants within the last year.
What is being tested?
The study tests an 'optimized' cord blood transplant (CBT) process developed by MSK. It includes evaluation methods, conditioning chemotherapy, total body irradiation before the transplant, and post-transplant care to assess side effects, disease relapse rates, graft-versus-host disease (GVHD), and immune recovery.
What are the potential side effects?
Potential side effects include reactions to chemotherapy or radiation therapy like fatigue and nausea; complications from CBT may involve infection risks due to weakened immunity or GVHD where donor cells attack the patient's body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 45 post-transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 45 post-transplant
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Time to neutrophil engraftment
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cord Blood TransplantExperimental Treatment2 Interventions
Adult patients with high-risk hematologic malignancies and a suitable double-unit CB graft will undergo work-up to assess protocol eligibility. CB graft selection will be based on established MSKCC guidelines. Patients will receive standard conditioning with Cy 50 mg/kg, Flu 150 mg/m2, Thio 10 mg/kg, and TBI 400 cGy according to the eligibility criteria. GVHD prophylaxis will consist of CSA and MMF starting day -3. The double-unit CB graft will be infused on day 0 per standard practice. Optimized CBT practices, will be implemented in this protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Conditioning Chemotherapy
2007
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
595,502 Total Patients Enrolled
Ioannis Politikos, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
46 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a high-risk form of MDS or MPD.I have been diagnosed with myelofibrosis or another cancer that affects my bone marrow.My Non-Hodgkin lymphoma is at high risk of getting worse if not in remission.My brain or spinal cord cancer is still visible on scans.I had a stem cell transplant from my own cells within the last year.My organs are functioning well and I can do most activities.I have not taken any checkpoint inhibitors in the past year.I've had radiation that makes it unsafe to receive 400cGy total body irradiation.I do not have an active, uncontrolled infection at the time of transplantation.My BPDCN is currently in remission.I have received the specified prior treatment.I have had two stem cell transplants.My AML is in its first complete remission but at high risk of returning.My ALL is in its first complete remission but at high risk of returning.My health is too poor to undergo certain medical procedures.My acute leukemia is currently in remission.
Research Study Groups:
This trial has the following groups:- Group 1: Cord Blood Transplant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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