Study of Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus
Phase II Study of Sequential Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus as Graft Versus Host Disease Prophylaxis
1 other identifier
interventional
32
1 country
2
Brief Summary
The purpose of this study is to measure the effectiveness of 2 drugs, tacrolimus and sirolimus, in preventing graft versus host disease (GVHD) after treatment with chemotherapy followed by donor cord blood transplantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 multiple-myeloma
Started Aug 2005
Typical duration for phase_2 multiple-myeloma
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 19, 2005
CompletedFirst Posted
Study publicly available on registry
August 23, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedJuly 25, 2016
July 1, 2016
2.3 years
August 19, 2005
July 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the effectiveness of tacrolimus and sirolimus in preventing graft versus host disease
2 years
Secondary Outcomes (2)
To evaluate the days to neutrophil engraftment and platelet engraftment
2 years
To evaluate the relapse rate and overall disease free survival
Interventions
Given three days before transplant and every day for 3-6 months after transplant. After first 100 days post-transplant, the dose will be reduced.
Given three days before transplant and every day for 3-6 months after transplant. After first 100 days post-transplant, the dose will be reduced.
Given starting on day 5 after transplant until the subjects white blood cell count recovers.
Given intravenously for 4 days before transplant (days 7, 5, 3, 1).
Given intravenously for 4 days before transplant (days 7, 5, 3, 1).
Given intravenously for six days prior to transplant (days 8,7,6,5,4,3).
Given intravenously on day 2 before transplant.
Eligibility Criteria
You may qualify if:
- Patients with hematologic malignancies for whom allogeneic stem cell transplantation is deemed clinically appropriate
- Non-Hodgkin's lymphoma, or Hodgkin's lymphoma: in Complete Remission \>2 (second complete remission, third complete remission, etc) or in partial remission
- Multiple myeloma: relapsed
- Chronic lymphocytic leukemia, Rai stage III or IV, or lymphocyte doubling time of 6 months, or stage I-II, having progressed after \> 2 chemotherapy regimens, in partial remission.
- Acute myelogenous or lymphoblastic leukemia in second or subsequent remission or in first remission with adverse cytogenetic or antecedent hematologic disorder
- Chronic myelogenous leukemia in accelerated or second stable phase, or imatinib resistant and not eligible for an ablative transplant
- Myelodysplasia, previously treated or not eligible for ablative transplant
- Age 18-65 years.
- ECOG performance status of 0, 1, or 2.
- Lack of 6/6 or 5/6 HLA-matched related, 10/10 matched unrelated donor, or unrelated donor not available within the time frame necessary to perform a potentially curative stem cell transplant.
You may not qualify if:
- Cardiac disease:
- symptomatic congestive heart failure or
- radionuclide ventriculogram (RVG) or echocardiogram determined left ventricular ejection fraction of \< 40%,
- active angina pectoris, or
- uncontrolled hypertension.
- Pulmonary disease:
- severe chronic obstructive lung disease, or
- symptomatic restrictive lung disease, or
- corrected DLCO of \< 50% of predicted.
- Renal disease:
- serum creatinine \> 2.0 mg/dl.
- Hepatic disease:
- serum bilirubin \> 2.0 mg/dl (except in the case of Gilbert's syndrome or hemolytic anemia in which the bilirubin can be elevated greater than 2.0mg/dl),
- SGOT or SGPT \> 3 x normal.
- Neurologic disease:
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Dana-Farber Cancer Institutecollaborator
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Related Publications (1)
Brown JA, Stevenson K, Kim HT, Cutler C, Ballen K, McDonough S, Reynolds C, Herrera M, Liney D, Ho V, Kao G, Armand P, Koreth J, Alyea E, McAfee S, Attar E, Dey B, Spitzer T, Soiffer R, Ritz J, Antin JH, Boussiotis VA. Clearance of CMV viremia and survival after double umbilical cord blood transplantation in adults depends on reconstitution of thymopoiesis. Blood. 2010 May 20;115(20):4111-9. doi: 10.1182/blood-2009-09-244145. Epub 2010 Jan 27.
PMID: 20107229DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen K Ballen, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 19, 2005
First Posted
August 23, 2005
Study Start
August 1, 2005
Primary Completion
November 1, 2007
Study Completion
November 1, 2011
Last Updated
July 25, 2016
Record last verified: 2016-07