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Alkylating agents

Umbilical Cord Blood Transplant for Cancer

Phase 2
Waitlist Available
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No other existing HLA-identical related donor available at the time of transplantation
Diagnosis of malignant or non-malignant disease including but not limited to specific conditions such as acute myeloid leukemia, acute lymphoblastic leukemia, Burkitt's lymphoma/leukemia, chronic myelogenous leukemia, juvenile myelomonocytic leukemia, advanced stage or relapsed lymphoma, neuroblastoma, Ewing's sarcoma, rhabdomyosarcoma, myelodysplastic syndromes, familial erythrophagocytic histiocytosis, histiocytosis unresponsive to medical management, inborn errors of metabolism, Langerhans cell histiocytosis unresponsive to medical management, immune deficiencies such as severe combined immune deficiency, Wiskott-Aldrich, hemoglobinopathies, severe aplastic anemia, Fanconi's anemia, metabolic storage diseases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is studying whether using stem cells from umbilical cord blood can help treat cancer or other diseases.

Who is the study for?
This trial is for young patients, age 21 or under, with certain cancers like leukemia and solid tumors, or non-malignant diseases such as Fanconi anemia. Participants must meet specific disease criteria detailed in the study's characteristics section.Check my eligibility
What is being tested?
The trial is testing how well stem cells from umbilical cord blood can replace immune cells destroyed by cancer treatments. It involves chemotherapy drugs (cyclophosphamide, melphalan), radiation therapy, and other agents to prepare the body for transplantation.See study design
What are the potential side effects?
Potential side effects include damage to organs from chemotherapy drugs and radiation, increased risk of infections due to weakened immunity, allergic reactions to medications used during transplant preparation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have a matching family donor for my transplant.
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I have been diagnosed with a serious blood, immune, or metabolic disorder.
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I am 21 years old or younger.

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
Comparison of the incidence of engraftment with historical data
Bone Transplantation
Impact of the use of umbilical cord blood as a source of hematopoietic stem cells

Trial Design

4Treatment groups
Experimental Treatment
Group I: Regimen DExperimental Treatment3 Interventions
Patients receive oral or IV busulfan 4 times daily on days -9 to -5, ATG IV over at least 6 hours on days -5 to -3, and cyclophosphamide IV over 30-60 minutes on days -5 to -2.
Group II: Regimen C (patients with Fanconi's anemia/related disorders)Experimental Treatment5 Interventions
Patients undergo TBI on day -6. Patients receive ATG IV over at least 6 hours and methylprednisolone IV on days -5 to -1 and fludarabine IV over 30 minutes and cyclophosphamide IV over 30-60 minutes on days -5 to -2.
Group III: Regimen B (patients who do not receive TBI)Experimental Treatment3 Interventions
Patients receive oral busulfan 4 times daily on days -8 to -5, and ATG IV over at least 6 hours and melphalan IV over 15-20 minutes on days -4 to -2.
Group IV: Regimen AExperimental Treatment3 Interventions
Patients undergo total body irradiation (TBI) two times daily on days -7 to -4. Patients receive cyclophosphamide IV over 30-60 minutes on days -3 and -2 and anti-thymocyte globulin (ATG) IV over at least 6 hours on days -3 to -1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Melphalan
FDA approved
anti-thymocyte globulin
2005
Completed Phase 3
~1000
Busulfan
FDA approved
Fludarabine
FDA approved
Methylprednisolone
FDA approved
radiation therapy
1994
Completed Phase 3
~13390

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
497 Previous Clinical Trials
2,799,945 Total Patients Enrolled
9 Trials studying Leukemia
79 Patients Enrolled for Leukemia
Kenneth G. Lucas, MDStudy ChairMilton S. Hershey Medical Center
9 Previous Clinical Trials
82 Total Patients Enrolled
1 Trials studying Leukemia

Media Library

Busulfan (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00084695 — Phase 2
Leukemia Research Study Groups: Regimen A, Regimen B (patients who do not receive TBI), Regimen C (patients with Fanconi's anemia/related disorders), Regimen D
Leukemia Clinical Trial 2023: Busulfan Highlights & Side Effects. Trial Name: NCT00084695 — Phase 2
Busulfan (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00084695 — Phase 2
~1 spots leftby Jun 2025
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