A Phase II Study of Umbilical Cord Blood Transplantation

NCT00676806 | Terminated Phase 2 Results DMC

• 1 other identifier: UCBT001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to determine whether Umbilical Cord Transplantation (UCB) can be substituted for adult bone marrow cells in the standard stem cell transplant regimens used at this hospital for subjects who do not have stem cell donors.

Conditions

Leukemia; Lymphoma; Multiple Myeloma; Aplastic Anemia

Keywords

Umbilical cord blood transplantation; full ablation conditioning; reduced intensity conditioning

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Neutrophil Engraftment

  Number of participants with neutrophil engraftment receiving umbilical cord blood for hematopoietic rescue following myeloablative or non-myeloablative conditioning

  +45 and 90 days

Secondary Outcomes (5)

• Proportion of Subjects With Platelet Engraftment

  +45, 90, and 180 days

• Incidence of Acute GVHD

  Day +100

• Infectious Complications in UCB Recipients.

  Day +100

• Incidence of Chronic GVHD

  After Day +100

• Compare Rates of Complications Between Patients Receiving Ablative vs. Non-myeloablative Conditioning Prior to UCB Transplantation

  +180 days

Study Arms (2)

Myeloablative conditioning

EXPERIMENTAL

Umbilical cord blood for hematopoietic rescue following myeloablative conditioning

Biological: Umbilical Cord Blood After Myeloablative Conditioning

Reduced intensity conditioning

EXPERIMENTAL

Umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning

Biological: Umbilical Cord Blood After Reduced-Intensity Conditioning

Interventions

Umbilical Cord Blood After Myeloablative Conditioning BIOLOGICAL

cyclophosphamide (60mg/m2 days -6 \& -5), fludarabine (25 mg/m2 days -7, -6, \& -5) and total body irradiation (days -3, -2, \& -1, total 1200 cGy) followed by cord blood infusion on day 0.

Also known as: Cytoxan, TBI, Fludara, Busulfex, UCBT

Myeloablative conditioning

Umbilical Cord Blood After Reduced-Intensity Conditioning BIOLOGICAL

Extracorporeal Photopheresis (days -8 \& -7), cyclophosphamide 50 mg/kg (day -6) pentostatin 4 mg/kg/d (continuous infusion days -5 \& -4), total body irradiation (days -3 \& -2, total 600cGy) followed by Umbilical Cord Blood Infusion day 0.

Also known as: Psoralen, Cytoxan, Nypent, TBI, UCBT

Reduced intensity conditioning

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients meeting eligibility criteria for unrelated allogeneic stem cell transplantation may be considered for participation on this clinical trial if and only if they meet each of the following criteria:
• Patients must have one of the following diagnoses
• Relapsed or refractory hematologic malignancy, or
• High risk hematologic malignancy in first remission, or
• Refractory acquired marrow failure state, or
• Inherited disorder of metabolism or marrow failure state without alternative curative therapy.
• Patients must not have a 6/6 or 5/6 HLA-matched related donor.
• Patients must not have a HLA-A, -B and -DRB1 high resolution matched unrelated donor following registry search, or cannot (in the opinion of the treating physician) wait the median 3 months to receive a MUD unit.
• Patients must demonstrate an ability to understand and willingness to sign the informed consent document
• Patients considered for myeloablative conditioning must satisfy the following additional criteria:
• Patients must be up to age 55 (inclusive)
• Patients must have serum direct bilirubin ≤ 2.0 mg/dl and transaminases ≤ 2x institution upper limit of normal
• Patients must have serum creatinine ≤ 2 mg/dl with creatinine clearance ≥ 60 ml/min (either calculated or measured).
• Patients must have MUGA scan or echocardiogram normal for the institution, but not less than 45% left ventricular ejection fraction and no clinical evidence of cardiac dysfunction.
• Patients must have an ECOG performance status of 0 or 1 (see Appendix C).

You may not qualify if:

• Patients are ineligible for participation on this trial if they meet any of the following criteria:
• Patients with a history of myocardial infarction within the preceding 6 months, significant arrhythmia within the preceding 3 months, uncontrolled hypertension or congestive heart failure are ineligible.
• Patients with unstable angina are not eligible.
• Pregnant or lactating women are ineligible.
• Male and female patients who do not agree to practice approved methods of birth control for the duration of the study are ineligible.
• Patients with uncontrolled infection are ineligible.
• Patients who are HIV positive or have evidence of chronic viral hepatitis are ineligible.
• Patients unable to comply with requirements for compliance with therapeutic plan and/or scheduled evaluations

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Leukemia; Lymphoma; Multiple Myeloma; Anemia, Aplastic

Interventions

Cyclophosphamide; fludarabine phosphate; Busulfan; Ficusin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Anemia; Bone Marrow Failure Disorders; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Butylene Glycols; Glycols; Alcohols; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Furocoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Andreas Klein, MD
• Organization: Tufts Medical Center

aklein2@tuftsmedicalcenter.org

617-636-8884

Study Officials

• Andreas Klein, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2008
• First Posted: May 13, 2008
• Study Start: July 1, 2005
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2014
• Last Updated: June 1, 2017
• Results First Posted: July 22, 2016

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)