Treatment of Single or Double Umbilical Cord Trans + Graft-versus-host Disease (GVHD) Prophylaxis w/ Tacrolimus & Mycophenolate Mofetil
This study has been terminated.
(slow accrual)
Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborator:
Information provided by (Responsible Party):
Brian Engelhardt, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00608517
First received: January 31, 2008
Last updated: May 9, 2012
Last verified: May 2012
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Results First Received: October 11, 2010
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Conditions: |
Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes |
| Interventions: |
Biological: anti-thymocyte globulin Drug: cyclophosphamide Drug: fludarabine phosphate Drug: methylprednisolone Radiation: total-body irradiation |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Recruitment period = 9/23/2005 through 8/15/2008 |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| A total of 7 people signed consent to take part in this study. Of those, 1 was determined to be ineligible. |
Reporting Groups
| Description | |
|---|---|
| Pediatric Myeloablative Conditioning | Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1. |
| Adult Myeloablative Conditioning | Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1. |
| Reduced-intensity Conditioning | Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1. |
Participant Flow: Overall Study
| Pediatric Myeloablative Conditioning | Adult Myeloablative Conditioning | Reduced-intensity Conditioning | |
|---|---|---|---|
| STARTED | 2 | 3 | 1 |
| COMPLETED | 1 | 3 | 1 |
| NOT COMPLETED | 1 | 0 | 0 |
| Death | 1 | 0 | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Pediatric Myeloablative Conditioning | Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1. |
| Adult Myeloablative Conditioning | Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1. |
| Reduced-intensity Conditioning | Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1. |
| Total | Total of all reporting groups |
Baseline Measures
| Pediatric Myeloablative Conditioning | Adult Myeloablative Conditioning | Reduced-intensity Conditioning | Total | |
|---|---|---|---|---|
|
Number of Participants
[units: participants] |
2 | 3 | 1 | 6 |
|
Age
[units: participants] |
||||
| <=18 years | 2 | 0 | 0 | 2 |
| Between 18 and 65 years | 0 | 3 | 1 | 4 |
| >=65 years | 0 | 0 | 0 | 0 |
|
Age
[units: years] Mean ± Standard Deviation |
8 ± 1 | 31 ± 1 | 42 ± 1 | 31 ± 1 |
|
Gender
[units: participants] |
||||
| Female | 1 | 1 | 1 | 3 |
| Male | 1 | 2 | 0 | 3 |
|
Region of Enrollment
[units: participants] |
||||
| United States | 2 | 3 | 1 | 6 |
Outcome Measures
| 1. Primary: | Number of Participants With 100-day Non-relapse Mortality [ Time Frame: 100 days ] |
| 2. Secondary: | Number of Participants With Sustained Donor Engraftment of Umbilical Cord Blood Stem Cells [ Time Frame: 42 days ] |
| 3. Secondary: | Number of Participants With Acute Graft-versus-host Disease (GVHD) [ Time Frame: 100 days ] |
| 4. Secondary: | Number of Participants Who Relapsed at 1 Year [ Time Frame: 1 year ] |
| 5. Secondary: | Number of Subjects With All-cause Mortality [ Time Frame: at 100 days ] |
| 6. Secondary: | Overall Survival [ Time Frame: 1 year ] |
| 7. Secondary: | Number of Participants With Chronic Graft Versus Host Disease (GVHD) [ Time Frame: 100 days ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| All Principal Investigators ARE employed by the organization sponsoring the study. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: Brian Engelhardt, M.D.
Organization: Vanderbilt-Ingram Cancer Center
phone: 615-936-1803
Organization: Vanderbilt-Ingram Cancer Center
phone: 615-936-1803
No publications provided
| Responsible Party: | Brian Engelhardt, MD, Vanderbilt-Ingram Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00608517 History of Changes |
| Obsolete Identifiers: | NCT00244036 |
| Other Study ID Numbers: | VICC BMT 0552, VU-VICC-BMT-0552 |
| Study First Received: | January 31, 2008 |
| Results First Received: | October 11, 2010 |
| Last Updated: | May 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |