LeukemiaPhase 2NCT00024050
Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome
A Phase 2 study testing busulfan, cyclophosphamide and cyclosporine in people with Leukemia and Myelodysplastic Syndromes, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Leukemia, Myelodysplastic Syndromes
- What is being tested?
- busulfan, cyclophosphamide and cyclosporine
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Feb 2001to Aug 2007
- 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 low or intermediate-risk myelodysplastic syndrome
- Refractory anemia (RA)
- RA with ringed sideroblasts
- No advanced myelodysplastic syndrome (i.e., at least 5% blasts in the marrow, more than 1% blasts in the peripheral blood, or blasts in the cerebrospinal fluid)
- No poor-risk cytogenetics (i.e., abnormalities of chromosome 7 or complex abnormalities)
- HLA-A, B, C, DRB1, and DQB1 compatible related or unrelated donor available
- Mismatch for a single HLA-A, B, C, DRB1, or DQB1 allele allowed
PATIENT CHARACTERISTICS:
Age:
- 65 and under
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- AST no greater than 2 times normal
Renal:
- Creatinine no greater than 2 times upper limit of normal
- Creatinine clearance at least 50%
Cardiovascular:
- No cardiac insufficiency requiring treatment
- No symptomatic coronary artery disease
Pulmonary:
- No severe hypoxemia (pO2 less than 70 mm Hg with DLCO less than 70% predicted)
- No mild hypoxemia (pO2 less than 80 mm Hg with DLCO less than 60% predicted)
Other:
- No other disease that would limit life expectancy
- HIV negative
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
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
About this study
Official title: Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation for the Treatment of "Less Advanced" Myelodysplasi
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have myelodysplastic syndrome.
Read the detailed description
OBJECTIVES:
- Determine the non-relapse toxicity and mortality on day 100 and at 1 year after transplantation in patients with low or intermediate-risk myelodysplastic syndrome treated with busulfan, cyclophosphamide, and allogeneic peripheral blood stem cell transplantation.
- Determine the incidence of donor stem cell engraftment and relapse-free survival in these patients treated with this regimen.
- Determine the incidence and severity of acute and chronic graft-versus-host disease and invasive fungal infections in these patients treated with this regimen.
- Determine the incidence of relapse in these patients treated with this regimen.
OUTLINE: Peripheral blood stem cells (PBSC) or bone marrow are harvested from a related or unrelated compatible donor. PBSC are selected for CD34+ cells.
Patients receive oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV on days -3 and -2. Allogeneic PBSC or bone marrow is infused on day 0.
As graft-versus-host disease prophylaxis, patients receive cyclosporine IV beginning on day -1 and continuing orally twice daily (if feasible) until day 51 followed by a taper. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
Patients are followed through day 100, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 3 years.
- Conditions
- Leukemia, Myelodysplastic Syndromes
- Being tested
- busulfan, cyclophosphamide, cyclosporine, methotrexate, allogeneic bone marrow transplantation
- Keywords
- refractory anemia, refractory anemia with ringed sideroblasts, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, childhood myelodysplastic syndromes
- Medical subject headings
- Leukemia, Myelodysplastic Syndromes, Anemia, Refractory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
busulfanDrug
cyclophosphamideDrug
cyclosporineDrug
methotrexateDrug
allogeneic bone marrow transplantationProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startFeb 2001
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies 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
- Treatment
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- H. Joachim Deeg, MD, Study chair, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00024050
- Sponsor's protocol ID
- 1536.00
- Other IDs
- FHCRC-1536.00, NCI-G01-2009, CDR0000068887
- Status last verified
- May 2010
- First submitted
- 13 Sep 2001
- 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
- Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation for the Treatment of "Less Advanced" Myelodysplasi
- ClinicalTrials.gov ID
- NCT00024050
- Acronym / sponsor ID
- 1536.00
- Conditions
- Leukemia, Myelodysplastic Syndromes
- Keywords
- refractory anemia, refractory anemia with ringed sideroblasts, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, childhood myelodysplastic syndromes
- 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
- Feb 2001
- Study completion
- Aug 2007 (actual)
- First posted
- 27 Jan 2003 (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: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have myelodysplastic syndrome.
Detailed description
OBJECTIVES:
- Determine the non-relapse toxicity and mortality on day 100 and at 1 year after transplantation in patients with low or intermediate-risk myelodysplastic syndrome treated with busulfan, cyclophosphamide, and allogeneic peripheral blood stem cell transplantation.
- Determine the incidence of donor stem cell engraftment and relapse-free survival in these patients treated with this regimen.
- Determine the incidence and severity of acute and chronic graft-versus-host disease and invasive fungal infections in these patients treated with this regimen.
- Determine the incidence of relapse in these patients treated with this regimen.
OUTLINE: Peripheral blood stem cells (PBSC) or bone marrow are harvested from a related or unrelated compatible donor. PBSC are selected for CD34+ cells.
Patients receive oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV on days -3 and -2. Allogeneic PBSC or bone marrow is infused on day 0.
As graft-versus-host disease prophylaxis, patients receive cyclosporine IV beginning on day -1 and continuing orally twice daily (if feasible) until day 51 followed by a taper. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
Patients are followed through day 100, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 3 years.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| busulfan | Drug | – |
| cyclophosphamide | Drug | – |
| cyclosporine | Drug | – |
| methotrexate | Drug | – |
| allogeneic bone marrow transplantation | Procedure or surgery | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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.
H. Joachim Deeg, MD study chair
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 busulfan, cyclophosphamide and cyclosporine in people with Leukemia and Myelodysplastic Syndromes, 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.
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.