LeukemiaPhase 2NCT00025545
Filgrastim-Treated Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Leukemia</p>
A Phase 2 study testing cyclophosphamide, methotrexate and peripheral blood stem cell transplantation in people with Leukemia, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Transplanted peripheral stem cells can sometimes be rejected by the body's tissues. Treating donor peripheral stem cells with filgrastim may increase the number of donor white blood cells. Read more about this study
- Who is it for?
- Ages Up to 55 years
- Conditions the study is for
- Leukemia
- What is being tested?
- cyclophosphamide, methotrexate and peripheral blood stem cell transplantation
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Mar 1996to Oct 2002
- 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 55 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- One of the following diagnoses:
- Primary acute leukemia beyond first remission
- High-risk acute myelogenous leukemia
- Acute lymphoblastic leukemia in first remission
- Must have HLA-matched donor identical for HLA-A, -B, and DRB1 alleles
- No HLA-matched identical sibling or haploidentical relative incompatible for 0 or 1 HLA-A, -B, or -DRB1 loci on the non-shared haplotype
- No leukoencephalopathy
PATIENT CHARACTERISTICS:
Age:
- 55 and under
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- SGOT no greater than 2 times normal
- Hepatitis B surface antigen negative
- No prior hepatitis C
Renal:
- No impaired renal function
- Creatinine less than 2 times normal
Cardiovascular:
- No symptomatic cardiac disease
Pulmonary:
- No active pulmonary disease
- DLCO at least 60% predicted
Other:
- HIV negative
- No disease or other malignancy that severely limits life expectancy
- No severe or life-threatening infection within the past 2 weeks
- No history of septate fungal infection or disseminated candidiasis
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior bone marrow or peripheral blood stem cell transplantation
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy greater than 3,000 cGy to whole brain
- No prior radiotherapy of 1,500 cGy to chest or abdomen
- At least 6 months since prior involved-field radiotherapy to chest or abdomen
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 Trial to Evaluate the Use of G-CSF-Mobilized Peripheral Blood Progenitor Cells as Hematopoietic Rescue in Patients With Acute Leukemia Undergoing Allografting From an Unrelated Donor
RATIONALE: Transplanted peripheral stem cells can sometimes be rejected by the body's tissues. Treating donor peripheral stem cells with filgrastim may increase the number of donor white blood cells. This may help to decrease the rejection of the transplanted cells in patients receiving them as treatment for acute leukemia.
PURPOSE: Phase II trial to study the effectiveness of filgrastim-treated donor peripheral stem cells in treating patients with acute leukemia who are undergoing peripheral stem cell transplantation.
Read the detailed description
OBJECTIVES:
- Determine whether filgrastim (G-CSF)-mobilized allogeneic peripheral blood stem cell transplantation reduces the incidence of non-leukemic mortality in patients with acute leukemia.
- Determine the kinetics and durability of engraftment after treatment with this regimen in these patients.
- Determine the incidence and severity of acute and chronic graft-versus-host disease in patients treated with this regimen.
- Determine the leukemia-free survival of patients treated with this regimen.
OUTLINE: Donors receive filgrastim (G-CSF) subcutaneously (SC) on days -5 to -1. Donors then undergo leukapheresis on days -1 and 0.
Patients undergo total body irradiation twice daily on days -7 to -4. Patients receive 2 doses of intrathecal methotrexate per local guidelines between days -10 and -3. Patients also receive cyclophosphamide IV on days -3 and -2. Patients receive infusion of allogeneic peripheral blood stem cells on day 0.
PROJECTED ACCRUAL: A total of 5-60 patients will be accrued for this study within 3 years.
- Conditions
- Leukemia
- Being tested
- cyclophosphamide, methotrexate, peripheral blood stem cell transplantation, radiation therapy
- Keywords
- recurrent childhood acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia, recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, adult acute lymphoblastic leukemia in remission, childhood acute lymphoblastic leukemia in remission, acute undifferentiated leukemia, secondary acute myeloid leukemia
- Medical subject headings
- Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Leukemia, Biphenotypic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclophosphamideDrug
methotrexateDrug
peripheral blood stem cell transplantationProcedure or surgery
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2003 (estimated)
- Study startMar 1996
- Primary completionOct 2002
- Study completionOct 2002
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
- 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
- Claudio Anasetti, MD, Study chair, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00025545
- Sponsor's protocol ID
- 1099.00
- Other IDs
- FHCRC-1099.00, NCI-H01-0078, CDR0000068972
- Status last verified
- May 2010
- First submitted
- 11 Oct 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
- A Phase II Trial to Evaluate the Use of G-CSF-Mobilized Peripheral Blood Progenitor Cells as Hematopoietic Rescue in Patients With Acute Leukemia Undergoing Allografting From an Unrelated Donor
- ClinicalTrials.gov ID
- NCT00025545
- Acronym / sponsor ID
- 1099.00
- Conditions
- Leukemia
- Keywords
- recurrent childhood acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia, recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, adult acute lymphoblastic leukemia in remission, childhood acute lymphoblastic leukemia in remission, acute undifferentiated leukemia, secondary acute myeloid leukemia
- 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
- Mar 1996
- Primary completion
- Oct 2002 (actual)
- Study completion
- Oct 2002 (actual)
- First posted
- 20 Jun 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: Transplanted peripheral stem cells can sometimes be rejected by the body's tissues. Treating donor peripheral stem cells with filgrastim may increase the number of donor white blood cells. This may help to decrease the rejection of the transplanted cells in patients receiving them as treatment for acute leukemia.
PURPOSE: Phase II trial to study the effectiveness of filgrastim-treated donor peripheral stem cells in treating patients with acute leukemia who are undergoing peripheral stem cell transplantation.
Detailed description
OBJECTIVES:
- Determine whether filgrastim (G-CSF)-mobilized allogeneic peripheral blood stem cell transplantation reduces the incidence of non-leukemic mortality in patients with acute leukemia.
- Determine the kinetics and durability of engraftment after treatment with this regimen in these patients.
- Determine the incidence and severity of acute and chronic graft-versus-host disease in patients treated with this regimen.
- Determine the leukemia-free survival of patients treated with this regimen.
OUTLINE: Donors receive filgrastim (G-CSF) subcutaneously (SC) on days -5 to -1. Donors then undergo leukapheresis on days -1 and 0.
Patients undergo total body irradiation twice daily on days -7 to -4. Patients receive 2 doses of intrathecal methotrexate per local guidelines between days -10 and -3. Patients also receive cyclophosphamide IV on days -3 and -2. Patients receive infusion of allogeneic peripheral blood stem cells on day 0.
PROJECTED ACCRUAL: A total of 5-60 patients will be accrued for this study within 3 years.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| cyclophosphamide | Drug | – |
| methotrexate | Drug | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
| radiation therapy | Radiation | – |
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.
Claudio Anasetti, 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 cyclophosphamide, methotrexate and peripheral blood stem cell transplantation in people with Leukemia, 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.