Chronic Myeloproliferative DisordersPhase 2NCT00096096
Tacrolimus and Mycophenolate Mofetil in Preventing Acute Graft-Versus-Host Disease in Patients With Advanced Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplantation
A Phase 2 study testing mycophenolate mofetil and tacrolimus in people with Chronic Myeloproliferative Disorders and Graft Versus Host Disease, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Tacrolimus and mycophenolate mofetil may be an effective treatment for graft-versus-host disease caused by donor stem cell transplantation. PURPOSE: This phase II trial is studying how well giving tacrolimus together with mycophenolate mofetil works in preventing acute graft-versus-host disease in patients… Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia
- What is being tested?
- mycophenolate mofetil and tacrolimus
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to May 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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following hematologic malignancies:
- Acute myeloid leukemia beyond first complete remission (CR1)
- Acute lymphoblastic leukemia beyond CR1
- Chronic myelogenous leukemia in second chronic phase, accelerated phase, or blastic phase
- Non-Hodgkin's lymphoma beyond CR2
- Hodgkin's lymphoma beyond CR2
- Multiple myeloma (any stage)
- Myelodysplastic syndromes beyond refractory anemia (including chronic myelomonocytic leukemia)
- Any refractory hematologic malignancy
- Advanced disease
- Scheduled for transplantation of mobilized allogeneic peripheral blood stem cells
- Genotypically HLA-identical stem cell donor available
PATIENT CHARACTERISTICS:
Age
- 65 and under
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- SGOT and SGPT ≤ 2.0 times ULN
Renal
- Creatinine clearance ≥ 60 mL/min
Pulmonary
- No acute pulmonary infection by chest x-ray
- No severe hypoxemia (partial O_2 < 70% of predicted) AND DLCO < 70% of predicted
- No mild hypoxemia (partial O_2 < 80% of predicted) AND DLCO < 60% of predicted
Other
- Not pregnant or nursing
- Negative pregnancy test
- No active systemic infection not controlled with antimicrobial therapy
- HIV negative (HIV-1 or other virus)
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent T-cell depleted hematopoietic stem cell graft
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
About this study
Official title: A Phase II Study of the Combination of Tacrolimus and Mycophenolate Mofetil for the Prevention of Acute Graft-Versus-Host Disease
RATIONALE: Tacrolimus and mycophenolate mofetil may be an effective treatment for graft-versus-host disease caused by donor stem cell transplantation.
PURPOSE: This phase II trial is studying how well giving tacrolimus together with mycophenolate mofetil works in preventing acute graft-versus-host disease in patients who are undergoing donor stem cell transplantation for advanced hematologic cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the efficacy of tacrolimus and mycophenolate mofetil in preventing acute graft-vs-host disease in patients with advanced hematologic malignancies undergoing allogeneic peripheral blood stem cell transplantation.
Secondary
- Determine the safety of this regimen in these patients.
OUTLINE: This is a non-randomized study.
Patients receive tacrolimus IV continuously or orally twice daily on days -1 to 60 followed by a taper to day 180. Patients also receive mycophenolate mofetil IV over 2 hours or orally twice daily on days 0-60 followed by a taper to day 180. Treatment is discontinued at day 180 in the absence of graft-vs-host disease.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 5-25 patients will be accrued for this study.
- Conditions
- Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes
- Being tested
- mycophenolate mofetil, tacrolimus
- Keywords
- graft versus host disease, accelerated phase chronic myelogenous leukemia, relapsing chronic myelogenous leukemia, recurrent adult Hodgkin lymphoma, refractory multiple myeloma, recurrent adult Burkitt lymphoma, chronic idiopathic myelofibrosis, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent mantle cell lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult lymphoblastic lymphoma, secondary acute myeloid leukemia, secondary myelodysplastic syndromes, adult acute lymphoblastic leukemia in remission, de novo myelodysplastic syndromes
- Medical subject headings
- Myeloproliferative Disorders, Graft vs Host Disease, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimusDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Secondary outcomes (2)
Safety
Area under the curve of plasma mycophenolic acid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2004 (estimated)
- Study startAug 2004
- Primary completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloproliferative DisordersStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe 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
- Supportive care
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Richard Nash, MD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00096096
- Sponsor's protocol ID
- 1893.00
- Other IDs
- FHCRC-1893.00, CDR0000391026
- Status last verified
- May 2010
- First submitted
- 9 Nov 2004
- Last updated
- 13 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of the Combination of Tacrolimus and Mycophenolate Mofetil for the Prevention of Acute Graft-Versus-Host Disease
- ClinicalTrials.gov ID
- NCT00096096
- Acronym / sponsor ID
- 1893.00
- Conditions
- Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes
- Keywords
- graft versus host disease, accelerated phase chronic myelogenous leukemia, relapsing chronic myelogenous leukemia, recurrent adult Hodgkin lymphoma, refractory multiple myeloma, recurrent adult Burkitt lymphoma, chronic idiopathic myelofibrosis, recurrent adult diffuse large cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2004
- Primary completion
- May 2006 (actual)
- First posted
- 9 Nov 2004 (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.
RATIONALE: Tacrolimus and mycophenolate mofetil may be an effective treatment for graft-versus-host disease caused by donor stem cell transplantation.
PURPOSE: This phase II trial is studying how well giving tacrolimus together with mycophenolate mofetil works in preventing acute graft-versus-host disease in patients who are undergoing donor stem cell transplantation for advanced hematologic cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the efficacy of tacrolimus and mycophenolate mofetil in preventing acute graft-vs-host disease in patients with advanced hematologic malignancies undergoing allogeneic peripheral blood stem cell transplantation.
Secondary
- Determine the safety of this regimen in these patients.
OUTLINE: This is a non-randomized study.
Patients receive tacrolimus IV continuously or orally twice daily on days -1 to 60 followed by a taper to day 180. Patients also receive mycophenolate mofetil IV over 2 hours or orally twice daily on days 0-60 followed by a taper to day 180. Treatment is discontinued at day 180 in the absence of graft-vs-host disease.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 5-25 patients will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| mycophenolate mofetil | Drug | – |
| tacrolimus | Drug | – |
Primary outcome
Efficacy
2 secondary outcomes
Safety
Area under the curve of plasma mycophenolic acid
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 13 May 2010.
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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.
Richard Nash, MD principal investigator
Fred Hutchinson Cancer Center
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 mycophenolate mofetil and tacrolimus in people with Chronic Myeloproliferative Disorders and Graft Versus Host Disease, run by Fred Hutchinson Cancer Center 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?
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 13 May 2010. 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?
Efficacy. 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 13 May 2010.