Hematologic MalignanciesPhase 2NCT00144703
Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Related Stem Cell Transplantation
A Phase 2 study testing Sirolimus and Tacrolimus in people with Hematologic Malignancies and Myelogenous Leukemia, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the ability of sirolimus to prevent graft versus host disease (GVHD) in patients following stem cell transplant from a related donor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancies, Myelogenous Leukemia, Acute Lymphoblastic Leukemia
- What is being tested?
- Sirolimus and Tacrolimus
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2002to Nov 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hematologic malignancies who will undergo allogeneic HSCT from matched family-members.
- Age greater than 18
- ECOG performance status 0-2
- Total bilirubin < 2.0 mg/dl
- AST < 90 IU
- Serum creatinine < 2.0 mg/dl
Who cannot join
- Active, uncontrolled infection
- Ejection fraction < 45% by echocardiogram or MUGA scan
- Forced vital capacity < 60%
- Uncontrolled hypertension
- Second transplantation
- Evidence of HIV infection
- Cholesterol > 300 mg/dl
- Relapsed aggressive Burkitt's or Burkitt's-like lymphoma
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Open Label Phase II Trial of Sirolimus in Combination With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Matched, Related Allogeneic Hematopoietic Stem Cell Transplantation
The purpose of this study is to evaluate the ability of sirolimus to prevent graft versus host disease (GVHD) in patients following stem cell transplant from a related donor.
Read the detailed description
- Therapy to prevent GVHD will consist of an infusion of tacrolimus intravenously and sirolimus orally once per day starting 3 days before stem cell infusion. This will take place in the hospital where the patient will remain for the duration of the transplant.
- Sirolimus will continue for 9 weeks at at stable dose, then will be tapered by 1/3 on week 9 and 1/3 on week 17. It will be stopped on week 26 if there is no significant evidence of GVHD. These dose modifications will occur at home and patients will be seen weekly for the first 2 months after discharge.
- If GVHD is present, the tapering schedule wil be slower and based upon the patient's clinical condition.
- Tacrolimus will be given orally once the patient is discharged from the hospital and will be tapered at the same schedule as sirolimus. Blood levels of both tacrolimus and sirolimus will be monitored and the dose adjusted accordingly.
- During the year following stem cell transplant, blood work will be performed to evaluate the immune system and GVHD.
- Conditions
- Hematologic Malignancies, Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, Non-Hodgkin's Lymphoma, Hodgkin's Disease
- Being tested
- Sirolimus, Tacrolimus
- Keywords
- Graft versus host disease, GVHD, Stem cell transplantation, sirolimus, tacrolimus
- Medical subject headings
- Hematologic Neoplasms, Leukemia, Myeloid, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes, Lymphoma, Non-Hodgkin, Hodgkin Disease, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirolimusDrug
TacrolimusDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility of using sirolimus and tacrolimus without methotrexate for GVHD prophylaxis after stem cell transplantation.
Secondary outcomes (3)
To compare the rates of grade II-IV and III-IV acute GVHD with historical controls
to determine the incidence of 100 day mortality after stem cell transplant using this regimen
to determine the overall survival at 1 year after transplantation in this patient population.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startJul 2002
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Corey S. Cutler, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Corey Cutler, MD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144703
- Sponsor's protocol ID
- 02-090
- Status last verified
- Jan 2009
- First submitted
- 1 Sep 2005
- Last updated
- 26 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Phase II Trial of Sirolimus in Combination With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Matched, Related Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00144703
- Acronym / sponsor ID
- 02-090
- Conditions
- Hematologic Malignancies, Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, Non-Hodgkin's Lymphoma, Hodgkin's Disease
- Keywords
- Graft versus host disease, GVHD, Stem cell transplantation, sirolimus, tacrolimus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- Jul 2002
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 5 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the ability of sirolimus to prevent graft versus host disease (GVHD) in patients following stem cell transplant from a related donor.
Detailed description
- Therapy to prevent GVHD will consist of an infusion of tacrolimus intravenously and sirolimus orally once per day starting 3 days before stem cell infusion. This will take place in the hospital where the patient will remain for the duration of the transplant.
- Sirolimus will continue for 9 weeks at at stable dose, then will be tapered by 1/3 on week 9 and 1/3 on week 17. It will be stopped on week 26 if there is no significant evidence of GVHD. These dose modifications will occur at home and patients will be seen weekly for the first 2 months after discharge.
- If GVHD is present, the tapering schedule wil be slower and based upon the patient's clinical condition.
- Tacrolimus will be given orally once the patient is discharged from the hospital and will be tapered at the same schedule as sirolimus. Blood levels of both tacrolimus and sirolimus will be monitored and the dose adjusted accordingly.
- During the year following stem cell transplant, blood work will be performed to evaluate the immune system and GVHD.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with hematologic malignancies who will undergo allogeneic HSCT from matched family-members.
- Age greater than 18
- ECOG performance status 0-2
- Total bilirubin < 2.0 mg/dl
- AST < 90 IU
Key exclusion criteria (8 listed)
- Active, uncontrolled infection
- Ejection fraction < 45% by echocardiogram or MUGA scan
- Forced vital capacity < 60%
- Uncontrolled hypertension
- Second transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sirolimus | Drug | – |
| Tacrolimus | Drug | – |
Primary outcome
To determine the feasibility of using sirolimus and tacrolimus without methotrexate for GVHD prophylaxis after stem cell transplantation.
3 secondary outcomes
To compare the rates of grade II-IV and III-IV acute GVHD with historical controls
to determine the incidence of 100 day mortality after stem cell transplant using this regimen
to determine the overall survival at 1 year after transplantation in this patient population.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corey Cutler, MD, MPH principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sirolimus and Tacrolimus in people with Hematologic Malignancies and Myelogenous Leukemia, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the feasibility of using sirolimus and tacrolimus without methotrexate for GVHD prophylaxis after stem cell transplantation.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2012.