LeukemiaPhase 2NCT00072579
Sargramostim in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission Following Initial Treatment
A Phase 2 study testing sargramostim in people with Leukemia, run by Wake Forest University Health Sciences at 15 sites in United States.
Trial summary
RATIONALE: Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may bring about complete remission in patients who have chronic phase chronic myelogenous leukemia. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Leukemia
- What is being tested?
- sargramostim
- How many people
- Not given
- Where
- 15 sitesUnited States
- Study dates
- May 2003to Dec 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed chronic phase chronic myelogenous leukemia (CML)
- Presence of t(9;22)(q34;q11) with at least 20 cells examined in metaphase by cytogenetic examination of the bone marrow
- Complete hematologic remission during prior therapy* as seen on 2 separate blood count analyses, defined by the following:
- WBC no greater than 10,000/mm^3 AND platelet count no greater than 450,000/mm^3
- Disappearance of all signs and symptoms of disease, including palpable splenomegaly
- Normal differential counts (i.e., absence of blasts, promyelocytes, myelocytes, and metamyelocytes) NOTE: *Continuation of therapy that led to complete hematologic remission is required during study participation
- Persistent cytogenetic disease despite 12 months of prior imatinib mesylate therapy, which may have included a trial dose-escalation OR intolerant of imatinib mesylate at a dose greater than 400 mg/day
- Not in complete cytogenetic remission within 30 days of study entry
- Persistent Philadelphia chromosome by bone marrow exam
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- More than 6 months
Hematopoietic
- See Disease Characteristics
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No uncontrolled active infective
- No serious medical or psychiatric illness that would prevent giving informed consent or limit survival to less than 6 months
- No other malignancy not in remission except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Prior sargramostim (GM-CSF) allowed
- Prior interferon alfa for CML allowed
- No prior stem cell transplantation
- Concurrent interferon alfa* for CML allowed NOTE: *No dose increase during study participation
Chemotherapy
- At least 4 weeks since prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery
- At least 4 weeks since prior surgery
Other
- Prior imatinib mesylate for CML allowed
- No other concurrent medication for CML
- Concurrent imatinib mesylate* for CML allowed NOTE: *No dose increase during study participation
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Alamance Cancer Center
Burlington, North Carolina, 27216
CCOP - Columbus
Columbus, Ohio, 43206
CCOP - Central Illinois
Decatur, Illinois, 62526
Hugh Chatham Memorial Hospital
Elkin, North Carolina, 28621
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27534-9479
Brody School of Medicine at East Carolina University
Greenville, North Carolina, 27858
Cancer Centers of the Carolinas - Eastside
Greenville, South Carolina, 29615
Kentuckiana Cancer Institute, PLLC
Louisville, Kentucky, 40202
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
CCOP - Western Regional, Arizona
Phoenix, Arizona, 85006-2726
Regional Radiation Oncology Center at Rome
Rome, Georgia, 30165
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: Phase II Study of GM-CSF in Patients With Chronic Phase Chronic Myeloid Leukemia (CP-CML) Who Are Not in Complete Cytogenetic Remission After Initial Therapy
RATIONALE: Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may bring about complete remission in patients who have chronic phase chronic myelogenous leukemia.
PURPOSE: This phase II trial is studying sargramostim to see how well it works in treating patients with chronic phase chronic myelogenous leukemia that is not in complete cytogenetic remission after initial treatment.
Read the detailed description
OBJECTIVES:
- Determine the efficacy and safety of sargramostim (GM-CSF) by cytogenetic examination of the bone marrow in patients with chronic phase chronic myelogenous leukemia who are not in complete cytogenetic remission after initial therapy.
OUTLINE: Patients receive sargramostim (GM-CSF) subcutaneously daily for 3 months in the absence of disease progression or unacceptable toxicity. Patients achieving no response receive GM-CSF for an additional 3 months. Patients failing to achieve a partial response or better after the second course of GM-CSF are removed from the study. Patients achieving a partial response after the first or second course of GM-CSF continue to receive GM-CSF for an additional 9 months. Patients are then re-evaluated. Patients achieving a complete cytologic response at 9 months then receive GM-CSF 3 times weekly in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 weeks.
PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study within 3 years.
- Conditions
- Leukemia
- Being tested
- sargramostim
- Keywords
- chronic phase chronic myelogenous leukemia, chronic myelogenous leukemia, BCR-ABL1 positive
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Chronic-Phase, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sargramostimBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytogenetic response (complete and partial)
Secondary outcomes (3)
Toxicity as assessed by the Expanded Common Toxicity Criteria v2.0
Time to progression
Survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2003 (estimated)
- Study startMay 2003
- Primary completionApr 2006
- Study completionDec 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 Wake Forest University Health SciencesThe 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
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Istvan Molnar, MD, Study chair, Wake Forest University Health SciencesBayard L. Powell, MD, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00072579
- Sponsor's protocol ID
- CCCWFU-23102
- Other IDs
- CDR0000340983, BRLX-02153, NCI-7350
- Status last verified
- Jun 2013
- First submitted
- 4 Nov 2003
- Last updated
- 19 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of GM-CSF in Patients With Chronic Phase Chronic Myeloid Leukemia (CP-CML) Who Are Not in Complete Cytogenetic Remission After Initial Therapy
- ClinicalTrials.gov ID
- NCT00072579
- Acronym / sponsor ID
- CCCWFU-23102
- Conditions
- Leukemia
- Keywords
- chronic phase chronic myelogenous leukemia, chronic myelogenous leukemia, BCR-ABL1 positive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2003
- Primary completion
- Apr 2006 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 5 Nov 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: Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may bring about complete remission in patients who have chronic phase chronic myelogenous leukemia.
PURPOSE: This phase II trial is studying sargramostim to see how well it works in treating patients with chronic phase chronic myelogenous leukemia that is not in complete cytogenetic remission after initial treatment.
Detailed description
OBJECTIVES:
- Determine the efficacy and safety of sargramostim (GM-CSF) by cytogenetic examination of the bone marrow in patients with chronic phase chronic myelogenous leukemia who are not in complete cytogenetic remission after initial therapy.
OUTLINE: Patients receive sargramostim (GM-CSF) subcutaneously daily for 3 months in the absence of disease progression or unacceptable toxicity. Patients achieving no response receive GM-CSF for an additional 3 months. Patients failing to achieve a partial response or better after the second course of GM-CSF are removed from the study. Patients achieving a partial response after the first or second course of GM-CSF continue to receive GM-CSF for an additional 9 months. Patients are then re-evaluated. Patients achieving a complete cytologic response at 9 months then receive GM-CSF 3 times weekly in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 weeks.
PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study within 3 years.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| sargramostim | Biological | – |
Primary outcome
Cytogenetic response (complete and partial)
3 secondary outcomes
Toxicity as assessed by the Expanded Common Toxicity Criteria v2.0
Time to progression
Survival
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 19 Jan 2017.
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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.
Istvan Molnar, MD study chair
Wake Forest University Health Sciences
Bayard L. Powell, MD
Wake Forest University Health Sciences
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sargramostim in people with Leukemia, run by Wake Forest University Health Sciences at 15 sites 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 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
Cytogenetic response (complete and partial). 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 19 Jan 2017.