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Stem Cell Transplant

Cord Blood Transplantation for Blood Cancers

Phase 2
Waitlist Available
Led By Peter McSweeney, MD
Research Sponsored by Colorado Blood Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have histologically proven hematologic malignancy and must meet accepted indications for allogeneic stem cell transplantation: Acute myeloid leukemia (AML): high-risk in first complete remission (CR), near first CR (< 20% marrow blasts after induction therapy), or beyond first remission. Acute lymphoblastic leukemia with high-risk features in first remission (Philadelphia chromosome positive or other similar high-risk features), near first CR (< 20% marrow blasts after induction therapy), or beyond first remission. Chronic myeloid leukemia: in chronic phase (CP) and have failed Gleevec or are intolerant and have signs of failing other treatments, or have history of accelerated or blast phases. Storage of autologous peripheral blood stem cells is recommended for this group for patients, particularly if in chronic phase. Non-Hodgkin's lymphoma: aggressive histology with relapsed or primary refractory disease and not eligible for autologous transplantation. Patients with low-grade histology must have either failed 2 or more lines of systemic chemotherapy including one rituximab-based regimen. Radioimmunotherapy will be considered the equivalent of one line of chemotherapy. Excluded if prior radiotherapy to chest or prior autologous transplantation. Myelodysplastic syndromes with International Prognostic Scoring System (IPSS) score of 1.5 or greater. Other hematological malignancies if approved by the pipeline meeting on a case by case basis. Must also be approved by principal investigator.
Have no HLA-matched or 1-antigen mismatched related donors and no HLA-matched unrelated stem cell donors, or delays involved in performing a search are likely to be detrimental to the patient.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will study how often neutrophils (a type of white blood cell) engraft after cord blood transplantation, which is when blood from a newborn baby's umbilical cord is used to replace bone marrow.

Who is the study for?
This trial is for people aged 18-49 with certain blood cancers like leukemia or lymphoma, who need a stem cell transplant but don't have a closely matched donor. They should be in good physical condition (ECOG status of 0 or 1) and their major organs must function well enough to handle high-dose therapy.Check my eligibility
What is being tested?
The study is testing whether transplanting one or two cord blood units can help the body's white blood cells recover after treatment for blood cancer. The minimum total cell dose from the cord blood units used will be at least 2 x 10^7 TNC/kg of patient weight.See study design
What are the potential side effects?
Potential side effects may include complications from low white blood cell counts, such as infection risk; reactions to the transplant like graft-versus-host disease; organ inflammation due to high-dose therapy; and general side effects from transplantation procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I don't have a closely matched stem cell donor, or finding one quickly is critical for my health.
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My leukemia is high-risk or not in its first remission.
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I am between 18 and 49 years old.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have a blood cancer that requires a stem cell transplant from a donor.
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My heart, lungs, liver, and kidneys are strong enough for intense treatment.
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My heart, lungs, liver, and kidneys are strong enough for intense treatment.
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I am between 18 and 49 years old.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My myelodysplastic syndrome is classified as moderate to high risk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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
Evaluate the incidence of neutrophil engraftment after transplantation of one or two cord blood units
Secondary outcome measures
Evaluate chimerism from double cord transplants to determine source of long term engraftment
Evaluate efficacy as measured by survival at 1 and 2 years after transplant
Evaluate incidence of platelet engraftment
+2 more

Find a Location

Who is running the clinical trial?

Colorado Blood Cancer InstituteLead Sponsor
3 Previous Clinical Trials
110 Total Patients Enrolled
Peter McSweeney, MDPrincipal InvestigatorColorado Blood Cancer Institute
3 Previous Clinical Trials
24 Total Patients Enrolled

Media Library

Cord Blood Transplantation (Stem Cell Transplant) Clinical Trial Eligibility Overview. Trial Name: NCT00328237 — Phase 2
Myelodysplastic Syndrome Research Study Groups:
Myelodysplastic Syndrome Clinical Trial 2023: Cord Blood Transplantation Highlights & Side Effects. Trial Name: NCT00328237 — Phase 2
Cord Blood Transplantation (Stem Cell Transplant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00328237 — Phase 2

Frequently Asked Questions

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

To what magnitude is this treatment hazardous to recipients?

"Given the Phase 2 designation, and thus limited safety data but no efficacy evidence, we give this intervention a score of 2."

Answered by AI

Are there any available slots for participants in this research?

"Clinicaltrials.gov indicates that this medical research is not currently enrolling participants, as it was posted in November 2005 and updated last on June 23rd 2006. However, there are 2050 other trials actively recruiting patients at the present moment."

Answered by AI

Is this experiment open to applicants aged 85 and above?

"According to the conditions of this clinical trial, only those aged between 18 and 49 are eligible for enrollment."

Answered by AI

Am I eligible to join this experiment?

"This clinical trial is looking to enrol 20 individuals aged between 18 and 49 who have been diagnosed with myelodysplastic syndromes. Additionally, they must meet the following criteria: Other hematological malignancies if approved by a pipeline meeting on an individual basis; authorised by principal investigator; Acute myeloid leukemia (AML) of high-risk in first complete remission (CR), near first CR (<20% marrow blasts after induction therapy); Chronic myeloid leukemia in chronic phase or had failed Gleevec treatment or were intolerant to it and showed signs of failing other treatments, as well as those with"

Answered by AI
~1 spots leftby Mar 2025