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Alkylating Agent

Cord Blood Transplant for Blood Cancers

Phase 2

Recruiting

Led By Maria Cancio, 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

Patients with specific organ function and performance status criteria including Karnofsky or Lansky score ≥ 70%, bilirubin ≤ 1.5 mg/dL, ALT ≤ 3 x upper limit of normal, pulmonary function ≥ 50% predicted, left ventricular ejection fraction ≥ 50%, age-adjusted Hematopoietic Cell Transplantation-Comorbidity Index (aaHCT-CI) ≤ 7, and renal function within specified ranges

Patients meeting specific criteria for Acute Lymphoblastic Leukemia (ALL) including complete first remission (CR1) at high risk for relapse, complete second remission (CR2), and primary refractory or relapsed ALL with minimal residual disease (MRD) after antibody therapy and/or CAR-T cell therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will look at the one-year mortality rate for people with life-threatening blood disorders who can't get a transplant from a matched donor.

Who is the study for?

This trial is for children and young adults up to age 21 with various high-risk blood cancers or non-malignant disorders, who lack a matched donor for transplantation. Participants must have certain types of leukemia or lymphoma in remission, specific metabolic diseases early in their course, adequate heart, lung, liver and kidney function, and no active central nervous system involvement by cancer.Check my eligibility

What is being tested?

The study tests the effectiveness of cord blood transplants combined with chemotherapy drugs (Clofarabine, Fludarabine, Busulfan) and immune suppressants (Cyclosporine-A, Mycophenolate Mofetil) on survival without treatment-related mortality after one year. It's a single-arm study meaning all participants receive the same intervention.See study design

What are the potential side effects?

Possible side effects include reactions to the infusion of cord blood cells; suppression of bone marrow leading to low blood counts; infections due to weakened immune system; damage to organs like liver and kidneys from chemotherapy drugs; graft-versus-host disease where donated cells attack patient's body.

Eligibility Criteria

Inclusion Criteria

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

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My leukemia is in remission but at high risk of returning, or it has returned after treatment.

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I have a high-risk blood disorder or lymphoma not in remission.

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My AML is in early remission or has less than 10% cancer cells in my bone marrow.

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I am 21 or younger and cannot find a suitable donor quickly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Treatment related mortality at 1 year after myeloablative cord transplant

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants with non-malignant and malignant hematologic disordersExperimental Treatment6 Interventions

Participants with life threatening non-malignant and malignant hematologic disorders who do not have a matched related donor for allogeneic transplantation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclosporine-A

2005

Completed Phase 3

~60

Mycophenolate Mofetil

1997

Completed Phase 4

~2380

Clofarabine

2007

Completed Phase 3

~1130

Fludarabine

2012

Completed Phase 3

~1100

Busulfan

2008

Completed Phase 3

~1120

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,935 Previous Clinical Trials

588,830 Total Patients Enrolled

Maria Cancio, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

2 Previous Clinical Trials

25 Total Patients Enrolled

Media Library

Busulfan (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04644016 — Phase 2

Acute Myeloid Leukemia Research Study Groups: Participants with non-malignant and malignant hematologic disorders

Acute Myeloid Leukemia Clinical Trial 2023: Busulfan Highlights & Side Effects. Trial Name: NCT04644016 — Phase 2

Busulfan (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04644016 — Phase 2

Frequently Asked Questions

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

Are there any patients that have not yet been enrolled in this clinical trial?

"Right now, this clinical trial is looking for participants. The most recent update on the progress of the study was on May 13th, 2022 but it was originally posted on November 20th, 2020."

Answered by AI

What is the primary condition that Fludarabine helps alleviate?

"Fludarabine is often used to treat glomerulosclerosis. Additionally, this medication can be utilized to help patients with dry eye syndromes and vernal keratoconjunctivitis that have not responded well to other forms of therapy."

Answered by AI

How many people are testing this medication?

"That is correct, the information available on clinicaltrials.gov indicates that this trial is currently seeking patients. This particular trial was posted on 20 November 2020 and updated 13 May 2022. The researchers conducting this study need to recruit 31 people from a single site."

Answered by AI

Could you please explain the risks associated with Fludarabine?

"Fludarabine is still in the early stages of clinical trials, so it received a score of 2."

Answered by AI

Has Fludarabine been proven effective in other research trials?

"As of now, 547 clinical trials involving Fludarabine are active with 56 in Phase 3. Many of these clinical trials take place in Philadelphia, yet there are 6229 locations for these sorts of trials globally."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cord Blood Transplant in Children and Young Adults With Blood Cancers and Non-malignant Disorders

2020. "Cord Blood Transplant in Children and Young Adults With Blood Cancers and Non-malignant Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04644016.

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