Acute Myelogenous LeukemiaPhase 2NCT00144677
Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Un-Related Stem Cell Transplantation
A Phase 2 study testing sirolimus and tacrolimus in people with Acute Myelogenous Leukemia and Graft Versus Host Disease, 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 an unrelated donor. This trial is designed to test the hypothesis that elimination of methotrexate in the unrelated donor group would lead to less… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Acute Myelogenous Leukemia, Graft Versus Host Disease, Acute Lymphoblastic Leukemia
- What is being tested?
- sirolimus and tacrolimus
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Jun 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Acute myelogenous leukemia(AML) in first or subsequent remission, in untreated first relapse or any treated relapse.
- Acute lymphoblastic leukemia(ALL) in first or subsequent remission, in untreated first relapse or any treated relapse.
- Chronic myelogenous leukemia in first or second chronic stable phase or in accelerated phase.
- Myelodysplastic syndromes or myeloproliferative diseases
- Non-Hodgkin's lymphoma or Hodgkin's disease in second or greater complete remission, in partial remission, or induction failure.
- Chronic lymphocytic leukemia, Rai stage 2-4, which has progressed after initial therapy.
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- Matched unrelated donor.
- Age 18-55 years at the time of stem cell transplantation
- ECOG performance status 0-2
- Life expectancy of 100 days without stem cell transplantation
- Total bilirubin < 2.0 mg/dl
- AST < 90 IU
- Serum creatinine < 2.0 mg/dl
- Ejection fraction > 40% by echocardiogram or gated nuclear medicine study.
Who cannot join
- Uncontrolled infection
- Forced vital capacity or DLCO < 50% predicted for age
- Uncontrolled hypertension
- Prior hematopoietic stem cell transplant
- Evidence of HIV infection or active Hepatitis B or C 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 Center
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 HLA-Matched, Unrelated, 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 an unrelated donor. This trial is designed to test the hypothesis that elimination of methotrexate in the unrelated donor group would lead to less transplant-related toxicity while still preserving the effective control of GVHD.
Read the detailed description
- Therapy to prevent GVHD will consist of an infusion of tacrolimus intravenously and sirolimus orally once daily 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 approximately 100 days at a stable dose, then it will be tapered slowly over the course of weeks to months to prevent a flare in GVHD.
- Patients will be seen in the clinic weekly for the first 2 months after discharge from the hospital. If GVHD is present, tapering schedule will be slower and based on the patient's clinical condition.
- Tacrolimus will also be given orally after the patient is discharged and will be tapered on the same schedule as sirolimus.
- During the year following stem cell transplant, blood tests will be performed to evaluate the immune system and graft versus host disease.
- Conditions
- Acute Myelogenous Leukemia, Graft Versus Host Disease, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndromes, Non-Hodgkin's Lymphoma
- Being tested
- sirolimus, tacrolimus
- Keywords
- Graft versus Host Disease, GVHD, sirolimus, tacrolimus, Stem cell transplant
- Medical subject headings
- Leukemia, Myeloid, Acute, Graft vs Host Disease, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myelodysplastic Syndromes, Lymphoma, Non-Hodgkin, Hodgkin 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 a combination of 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 control
to determine the incidence of 100 day mortality using this GVHD prophylaxis regimen
to determine the overall survival after one year of 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 startNov 2003
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myelogenous LeukemiaStudies 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
- 30 participants
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- 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
- NCT00144677
- Sponsor's protocol ID
- 03-290
- Status last verified
- Mar 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 HLA-Matched, Unrelated, Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00144677
- Acronym / sponsor ID
- 03-290
- Conditions
- Acute Myelogenous Leukemia, Graft Versus Host Disease, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndromes, Non-Hodgkin's Lymphoma
- Keywords
- Graft versus Host Disease, GVHD, sirolimus, tacrolimus, Stem cell transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Nov 2003
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 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 an unrelated donor. This trial is designed to test the hypothesis that elimination of methotrexate in the unrelated donor group would lead to less transplant-related toxicity while still preserving the effective control of GVHD.
Detailed description
- Therapy to prevent GVHD will consist of an infusion of tacrolimus intravenously and sirolimus orally once daily 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 approximately 100 days at a stable dose, then it will be tapered slowly over the course of weeks to months to prevent a flare in GVHD.
- Patients will be seen in the clinic weekly for the first 2 months after discharge from the hospital. If GVHD is present, tapering schedule will be slower and based on the patient's clinical condition.
- Tacrolimus will also be given orally after the patient is discharged and will be tapered on the same schedule as sirolimus.
- During the year following stem cell transplant, blood tests will be performed to evaluate the immune system and graft versus host disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Acute myelogenous leukemia(AML) in first or subsequent remission, in untreated first relapse or any treated relapse.
- Acute lymphoblastic leukemia(ALL) in first or subsequent remission, in untreated first relapse or any treated relapse.
- Chronic myelogenous leukemia in first or second chronic stable phase or in accelerated phase.
- Myelodysplastic syndromes or myeloproliferative diseases
- Non-Hodgkin's lymphoma or Hodgkin's disease in second or greater complete remission, in partial remission, or induction failure.
Key exclusion criteria (7 listed)
- Uncontrolled infection
- Forced vital capacity or DLCO < 50% predicted for age
- Uncontrolled hypertension
- Prior hematopoietic stem cell transplant
- Evidence of HIV infection or active Hepatitis B or C infection
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 a combination of 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 control
to determine the incidence of 100 day mortality using this GVHD prophylaxis regimen
to determine the overall survival after one year of 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 Acute Myelogenous Leukemia and Graft Versus Host Disease, 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 14 inclusion and 7 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 a combination of 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.