LeukemiaPhase 2NCT00005984
Cyclophosphamide and Filgrastim Followed By SCT in Patients With Chronic or Accelerated Phase Myelogenous Leukemia
A Phase 2 study testing cyclophosphamide, filgrastim and recombinant interferon alfa in people with Leukemia, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
RATIONALE: Giving colony-stimulating factors, such as G-CSF, and cyclophosphamide helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored. Chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell transplant. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Leukemia
- What is being tested?
- cyclophosphamide, filgrastim and recombinant interferon alfa
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2000to Sep 2005
- 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 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed chronic or accelerated phase chronic myelogenous leukemia (CML)
- Philadelphia chromosome positive OR
- BCR/ABL rearrangement
- Ineligible or refused to participate in ongoing allogeneic marrow donor transplant protocols
- 70 and under
- Performance status:
Show all 22Show fewer
- Age 65-70 years:
- Karnofsky 80-100%
- Under 65 years:
- Karnofsky 90-100%
- Renal:
- Age 65-70 years:
- Creatinine clearance greater than 60 mL/min (if creatinine at least 1.5 mg/dL)
- Under 65 years:
- Not specified
- Cardiovascular:
- Age 65-70 years:
- LVEF at least 45%
- Pulmonary:
- Age 65-70 years:
- If history of smoking or respiratory symptoms, spirometry and DLCO must be greater then 50% of predicted
- Normal organ function (excluding bone marrow)
Who cannot join
- Blast crisis or post blast crisis
- Severe fibrosis defined by bilateral trephine biopsies
- Splenomegaly (below umbilicus) that does not respond to chemotherapy and/or radiotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
About this study
Official title: Autologous Marrow Transplantation for Chronic Myelogenous Leukemia Using Stem Cells Obtained After In Vivo Cyclophosphamide/G-CSF Priming
RATIONALE: Giving colony-stimulating factors, such as G-CSF, and cyclophosphamide helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored. Chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy.
PURPOSE: This phase II trial is studying how well cyclophosphamide plus filgrastim followed by stem cell transplant works in treating patients with chronic phase or accelerated phase chronic myelogenous leukemia.
Read the detailed description
OBJECTIVES:
- Assess the clinical outcomes, survival, and morbidity of patients with chronic or accelerated phase chronic myelogenous leukemia when treated with cyclophosphamide and filgrastim (G-CSF) followed by autologous peripheral blood stem cell transplantation.
- Determine whether priming with cyclophosphamide and filgrastim (G-CSF) increases the fraction of benign Philadelphia chromosome negative hematopoietic progenitors in peripheral blood stem cells (PBSC) and reduces the incidence of persistent or recurrent leukemia after autologous transplantation with mobilized PBSC in these patients.
OUTLINE: Patients receive priming therapy consisting of cyclophosphamide IV over 2 hours on day 1 and filgrastim (G-CSF) daily subcutaneously (SQ) starting on day 5 and continuing until completion of leukapheresis. Peripheral blood stem cells (PBSC) are collected between days 14-21.
Patients then receive preparative therapy for transplant consisting of cyclophosphamide IV over 2 hours on days -7 and -6 and total body irradiation twice a day on days -4 through -1. Patients receive the PBSC transplantation on day 0. Patients also receive G-CSF IV starting on day 0 and continuing until blood counts recover. Patients then receive interferon alfa SQ daily in the absence of unacceptable toxicity or disease progression.
Patients are followed at 3 weeks; then at 3, 6, 9, 12, and 18 months; and then annually for 5 years.
PROJECTED ACCRUAL: Not specified
- Conditions
- Leukemia
- Being tested
- cyclophosphamide, filgrastim, recombinant interferon alfa, peripheral blood stem cell transplantation, radiation therapy
- Keywords
- chronic phase myelogenous leukemia, accelerated phase myelogenous leukemia
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclophosphamideDrug
Also called Endoxan, Cytoxan
intravenously over 2 hours on day 1 and on days -7 and -6
filgrastimDrug
Also called NEUPOGEN®
filgrastim (G-CSF) daily subcutaneously (SQ) starting on day 5 and continuing until completion of leukapheresis. Patients also receive G-CSF IV starting on day 0 and continuing until blood counts recover
recombinant interferon alfaDrug
Also called INTRON® A
Beginning on Day 1, subcutaneous (SQ) daily administration in the absence of unacceptable toxicity or disease progression
peripheral blood stem cell transplantationProcedure or surgery
Also called bone marrow transplant
Patients receive the PBSC transplantation on day 0.
radiation therapyProcedure or surgery
Also called irradiation
total body irradiation twice a day on days -4 through -1
| Study group | Role | What they receive |
|---|---|---|
| Patients with CML | Experimental | Patients treated for chronic accelerated phase and/or chronic myelogenous leukemia (CML) Receives: Drug: cyclophosphamide; Drug: filgrastim; Drug: recombinant interferon alfa; Procedure: peripheral blood stem cell transplantation; Procedure: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to hemopoietic recovery after transplantation
Detection of the Philadelphia chromosome or the BCR/ABL gene abnormality in post-transplantation marrow samples
Secondary outcomes (4)
Time to initial hospital discharge
Peritransplantation toxicity
Quality of life at various time points
Cause of death
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 startAug 2000
- Primary completionSep 2005
- Study completionSep 2005
Why it stopped: Study terminated as principal investigator \[PI\] left the university.
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 Masonic Cancer Center, University of MinnesotaThe 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Investigators
- Catherine M. Verfaillie, MD, Study chair, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005984
- Sponsor's protocol ID
- 1996LS183
- Other IDs
- UMN-MT-1996-11
- Status last verified
- Sep 2017
- First submitted
- 5 Jul 2000
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Marrow Transplantation for Chronic Myelogenous Leukemia Using Stem Cells Obtained After In Vivo Cyclophosphamide/G-CSF Priming
- ClinicalTrials.gov ID
- NCT00005984
- Acronym / sponsor ID
- 1996LS183
- Conditions
- Leukemia
- Keywords
- chronic phase myelogenous leukemia, accelerated phase myelogenous leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated as principal investigator \[PI\] left the university.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Aug 2000
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (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: Giving colony-stimulating factors, such as G-CSF, and cyclophosphamide helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored. Chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy.
PURPOSE: This phase II trial is studying how well cyclophosphamide plus filgrastim followed by stem cell transplant works in treating patients with chronic phase or accelerated phase chronic myelogenous leukemia.
Detailed description
OBJECTIVES:
- Assess the clinical outcomes, survival, and morbidity of patients with chronic or accelerated phase chronic myelogenous leukemia when treated with cyclophosphamide and filgrastim (G-CSF) followed by autologous peripheral blood stem cell transplantation.
- Determine whether priming with cyclophosphamide and filgrastim (G-CSF) increases the fraction of benign Philadelphia chromosome negative hematopoietic progenitors in peripheral blood stem cells (PBSC) and reduces the incidence of persistent or recurrent leukemia after autologous transplantation with mobilized PBSC in these patients.
OUTLINE: Patients receive priming therapy consisting of cyclophosphamide IV over 2 hours on day 1 and filgrastim (G-CSF) daily subcutaneously (SQ) starting on day 5 and continuing until completion of leukapheresis. Peripheral blood stem cells (PBSC) are collected between days 14-21.
Patients then receive preparative therapy for transplant consisting of cyclophosphamide IV over 2 hours on days -7 and -6 and total body irradiation twice a day on days -4 through -1. Patients receive the PBSC transplantation on day 0. Patients also receive G-CSF IV starting on day 0 and continuing until blood counts recover. Patients then receive interferon alfa SQ daily in the absence of unacceptable toxicity or disease progression.
Patients are followed at 3 weeks; then at 3, 6, 9, 12, and 18 months; and then annually for 5 years.
PROJECTED ACCRUAL: Not specified
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with CML | Experimental | Drug: cyclophosphamide, Drug: filgrastim, Drug: recombinant interferon alfa, Procedure: peripheral blood stem cell transplantation, Procedure: radiation therapyPatients treated for chronic accelerated phase and/or chronic myelogenous leukemia (CML) |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (22 listed)
- Histologically confirmed chronic or accelerated phase chronic myelogenous leukemia (CML)
- Ineligible or refused to participate in ongoing allogeneic marrow donor transplant protocols
- 70 and under
- Performance status:
- Renal:
Key exclusion criteria (3 listed)
- Blast crisis or post blast crisis
- Severe fibrosis defined by bilateral trephine biopsies
- Splenomegaly (below umbilicus) that does not respond to chemotherapy and/or radiotherapy
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 |
|---|---|---|
| cyclophosphamideAlso: Endoxan, Cytoxanintravenously over 2 hours on day 1 and on days -7 and -6 | Drug | Patients with CML |
| filgrastimAlso: NEUPOGEN®filgrastim (G-CSF) daily subcutaneously (SQ) starting on day 5 and continuing until completion of leukapheresis. Patients also receive G-CSF IV starting on day 0 and continuing until blood counts recover | Drug | Patients with CML |
| recombinant interferon alfaAlso: INTRON® ABeginning on Day 1, subcutaneous (SQ) daily administration in the absence of unacceptable toxicity or disease progression | Drug | Patients with CML |
| peripheral blood stem cell transplantationAlso: bone marrow transplantPatients receive the PBSC transplantation on day 0. | Procedure or surgery | Patients with CML |
| radiation therapyAlso: irradiationtotal body irradiation twice a day on days -4 through -1 | Procedure or surgery | Patients with CML |
Primary outcome
Time to hemopoietic recovery after transplantation
Detection of the Philadelphia chromosome or the BCR/ABL gene abnormality in post-transplantation marrow samples
4 secondary outcomes
Time to initial hospital discharge
Peritransplantation toxicity
Quality of life at various time points
Cause of death
Results and safety
The study was stopped early (reason given: Study terminated as principal investigator \[PI\] left the university.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 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.
Catherine M. Verfaillie, MD study chair
Masonic Cancer Center, University of Minnesota
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, filgrastim and recombinant interferon alfa in people with Leukemia, run by Masonic Cancer Center, University of Minnesota 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 22 inclusion and 3 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: stopped early, as of the sponsor's last update on 29 Nov 2017. 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 was stopped early (reason given: Study terminated as principal investigator \[PI\] left the university.). Results are not available in the source record.
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?
Time to hemopoietic recovery after transplantation. The study lists 2 primary outcomes in all. 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 29 Nov 2017.