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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 1 year post transplant
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~1 year post transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year 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
Overall survival (OS)
Secondary outcome measures
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
1,936 Previous Clinical Trials
588,844 Total Patients Enrolled
Ioannis Politikos, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
46 Total Patients Enrolled

Media Library

Conditioning Chemotherapy (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05884333 — Phase 2
Acute Myeloid Leukemia Research Study Groups: Cord Blood Transplant
Acute Myeloid Leukemia Clinical Trial 2023: Conditioning Chemotherapy Highlights & Side Effects. Trial Name: NCT05884333 — Phase 2
Conditioning Chemotherapy (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05884333 — Phase 2

Frequently Asked Questions

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

What is the aggregate number of individuals taking part in this medical study?

"Accurately, according to clinicaltrials.gov, the trial is currently enrolling participants and was initially posted on May 22nd 2023 with a subsequent update taking place that same day. 54 patients are needed from 7 distinct medical centres."

Answered by AI

Has the FDA sanctioned Cord Blood Transplant as a viable medical option?

"Given the Phase 2 status of this clinical trial, which implies limited safety data and no efficacy evidence, Power assigned a score of 2 to Cord Blood Transplant's overall safety."

Answered by AI

For which demographics is this clinical investigation most advantageous?

"This clinical trial seeks a total of 54 participants with acute myeloid leukemia, ranging in age from 21 to 65 years old."

Answered by AI

Are there currently any available openings for volunteers to participate in this research?

"Based on the information found on clinicaltrials.gov, this trial is actively enrolling subjects with an original post date of May 22nd 2023 and a most recent update dated for the same day."

Answered by AI

Will individuals younger than 55 years-old be accepted into the research?

"Eligibility requirements for this clinical trial specify that the participants must be between 21 and 65 years old. In contrast, 534 trials are available to those below 18 and 1584 specifically target seniors age 65 or above."

Answered by AI

How many health care facilities are conducting this trial?

"Seven medical centres are involved in this trial, among which three provide the participants with consent services. These include Memorial Sloan Kettering Monmouth (Consent only) based in Middletown, Memorial Sloan Kettering Bergen (Consent only) located at Montvale and finally Memorial Sloan Kettering Suffolk-Commack (Consent only), situated in Commack. The other four sites complete the list of participating institutions."

Answered by AI
~36 spots leftby May 2028