LymphomaPhase 2NCT00005985
Filgrastim and Chemotherapy Followed by Peripheral Stem Cell Transplant in Treating Patients With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
A Phase 2 study testing filgrastim, carmustine and cyclophosphamide in people with Lymphoma, run by Masonic Cancer Center, University of Minnesota 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. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- filgrastim, carmustine and cyclophosphamide
- Type of treatment
- Surgery or procedure
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2000to Feb 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 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- One of the following histologically confirmed diagnoses
- High grade non-Hodgkin's lymphoma:
- Immunoblastic or small noncleaved cell lymphoma (Burkitt's or non-Burkitt's) in complete or partial remission after initial therapy
- Localized (stage I or Zeigler stage A) small noncleaved (Burkitt's or non-Burkitt's) after relapse or incomplete response to initial therapy
- Lymphoblastic lymphoma in second or greater complete or partial response
- High risk lymphoblastic lymphoma in first complete remission or after initial therapy (high risk factors include stage IV disease, LDH greater than 2 times normal, and 2 or more extranodal sites)
- Intermediate grade non-Hodgkin's lymphoma:
- Diffuse large cell lymphoma
- Diffuse mixed cell lymphoma
- Diffuse small cleaved cell lymphoma
- Follicular large cell lymphoma
- In second or greater complete or partial remission OR
- High risk in first complete remission or after initial therapy
- High risk features include:
- No complete response after 12 weeks of initial combination chemotherapy
- Bulky disease (greater than 10 cm nodal masses or mediastinal disease involving greater than 1/3 of the chest diameter
- Malignant pleural effusion
- Liver involvement
- LDH greater than 2 times upper limit of normal at diagnosis
- At least 2 extranodal sites
- Low grade non-Hodgkin's lymphoma:
- Follicular small cleaved cell lymphoma
- Follicular mixed cell lymphoma
- Diffuse small lymphocytic lymphoma
- In first or greater complete response OR
- Following initial treatment if complete response is not achieved
- In second or greater complete or partial response if treated at diagnosis without clinical symptoms necessitating treatment
- T-cell lymphoma (nonlymphoblastic, intermediate, or high grade lymphomas) after initial therapy whether or not complete response is achieved
- Hodgkin's lymphoma
- Stage I and II disease treated with primary radiotherapy and failure of at least one combination chemotherapy regimen
- Stage III and IV disease with failure on mechlorethamine, vincristine, procarbazine, and prednisone (MOPP)-like regimen, alternative noncross resistant regimen (e.g., doxorubicin, bleomycin, vinblastine, and dacarbazine [ABVD]), or a combination (e.g., MOPP-ABV)
- High risk features allowed including:
- Failure to achieve initial complete remission with MOPP and/or ABVD and crossover or hybrid therapy
- Relapse within 6 months after initial therapy
- Relapse after initial radiotherapy with complete response longer than 1 year since initial therapy and subsequent failure on MOPP and/or ABVD or hybrid
- Bulky mediastinal disease after initial therapy and residual mass of at least 5 cm with other features of persisting disease (e.g., Gallium scan positive, high LDH, enlarging on serial x-rays, or positive biopsy)
- No HIV or HTLV-1 associated lymphomas
- No resistant or refractory lymphoma (no partial response following up to 3 courses of combination chemotherapy)
- No active ischemic or degenerative CNS disease NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
- 70 and under
Performance status:
- Age 65-70 years:
- Karnofsky 80-100%
- Under 65 years:
- ECOG 0-1 (2 allowed if symptoms are directly related to lymphoma)
Life expectancy:
- Greater than 8 weeks
Hematopoietic:
- Not specified
Hepatic:
- No prior or current chronic liver disease
- Bilirubin no greater than 1.5 mg/dL
- AST and alkaline phosphatase less than 2 times normal
Renal:
- Age 65-70 years:
- Creatinine clearance greater than 60 mL/min (if creatinine at least 1.5 mg/dL)
- Under 65 years:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance greater than 50 mL/min
Cardiovascular:
- LVEF at least 45% by MUGA
- No symptoms of cardiac disease
- No active ischemic heart disease
- No uncontrolled hypertension
Pulmonary:
- Age 65-70 years:
- If history of smoking or respiratory symptoms, spirometry and DLCO must be greater than 50% of predicted
- All ages:
- No obstructive airway disease
- No resting hypoxemia (PO_2 less than 80)
- DLCO at least 50% of predicted
Other:
- No poorly controlled diabetes
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- Must have prior chemotherapy to attempt to achieve complete response
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No radiotherapy to residual disease prior to transplantation
Surgery:
- Not specified
Other:
- Concurrent IV antibiotic therapy allowed for fever or signs of infection
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: Primed Peripheral Blood Stem Cell Autologous Transplantation for Lymphoma and Hodgkin's Disease
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: This phase II trial is studying how well giving filgrastim together with chemotherapy and peripheral stem cell transplant works in treating patients with Hodgkin's lymphoma or non-Hodgkin's lymphoma.
Read the detailed description
OBJECTIVES:
- Assess the clinical outcomes, survival, and morbidity of transplantation in patients with Hodgkin's lymphoma or non-Hodgkin's lymphoma when treated with filgrastim (G-CSF) followed by high dose chemotherapy plus G-CSF followed by autologous peripheral blood stem cell (PBSC) transplantation.
- Determine whether sufficient PBSC can be collected for use in autologous transplantation in these patients when mobilized with hematopoietic growth factor alone compared to chemotherapy plus growth factor.
- Determine whether these primed PBSC support prompt lymphoid and myeloid hematopoietic recovery after transplantation in these patients.
- Compare the numbers of committed progenitor cells and/or primitive, pluripotential hematopoietic stem cells with these two priming techniques.
- Compare the numbers of tumor cells in cryopreserved PBSC following these priming techniques.
- Evaluate response and extended relapse free survival in conjunction with rapid hematopoietic reconstitution and limited transplant associated morbidity and mortality in these patients when treated with these regimens.
OUTLINE: In the first priming phase, patients receive filgrastim (G-CSF) subcutaneously (SQ) daily on days 1-7 and peripheral blood stem cells are collected on days 6-8.
At least 48 hours after the last dose of G-CSF and after the third leukapheresis, patients receive the second priming, which consists of cyclophosphamide IV over 2 hours on day 1 and cytarabine IV over 1 hour every 12 hours for a total of 2 doses on day 1. Patients also receive mitoxantrone IV over 1 hour daily and dexamethasone IV every 12 hours for a total of 4 doses on days 1-2. Patients receive G-CSF SQ daily beginning on day 4 and continuing until the completion of leukapheresis. PBSC are collected on 3 consecutive days after blood counts recover.
In the transplant phase, patients with non-Hodgkin's lymphoma who have not exceeded pretransplant radiotherapy limits receive cyclophosphamide IV over 2 hours on days -7 and -6 and total body irradiation twice daily on days -4 through -1. Autologous PBSC are reinfused on day 0. Patients receive G-CSF IV daily beginning on day 0 and continuing until day 21 or until blood counts recover.
Patients with Hodgkin's lymphoma or patients with non-Hodgkin's lymphoma who have exceeded pretransplant radiotherapy limits receive cyclophosphamide IV over 2 hours daily on days -6 through -3, carmustine IV over 1 hour on day -6, and etoposide IV over 4 hours every 12 hours for a total of 6 doses on days -6 through -4. Autologous PBSC are reinfused on day 0. Patients also receive G-CSF IV daily beginning on day 0 and continuing until day 21 or until blood counts recover.
All patients receive radiotherapy for any residual nodal masses measuring at least 2 cm 5 days a week beginning on day 28.
Patients are followed at day 100, then every 3 months for 1 year, then every 6 months for 2 years, and then annually thereafter.
This was changed to a treatment guideline study.
- Conditions
- Lymphoma
- Being tested
- filgrastim, carmustine, cyclophosphamide, cytarabine, dexamethasone
- Keywords
- stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, recurrent adult Hodgkin lymphoma, stage I grade 1 follicular lymphoma, stage I grade 2 follicular lymphoma, stage I grade 3 follicular lymphoma, stage I adult diffuse small cleaved cell lymphoma, stage I adult diffuse mixed cell lymphoma, stage I adult diffuse large cell lymphoma, stage I adult immunoblastic large cell lymphoma, stage I adult lymphoblastic lymphoma, stage I adult Burkitt lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse large cell lymphoma
- Medical subject headings
- Lymphoma, Hodgkin Disease, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
carmustineDrug
cyclophosphamideDrug
cytarabineDrug
dexamethasoneDrug
etoposideDrug
mitoxantrone hydrochlorideDrug
peripheral blood stem cell transplantationProcedure or surgery
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival at 2 years
Secondary outcomes (1)
Relapse or progression transplant related mortality at 1½ years
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 completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies 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
- Masking
- None (open label)
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel J. Weisdorf, MD, Study chair, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005985
- Sponsor's protocol ID
- 1996LS155
- Other IDs
- UMN-MT-9527, UMN-MT-1995-27
- Status last verified
- Nov 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
- Primed Peripheral Blood Stem Cell Autologous Transplantation for Lymphoma and Hodgkin's Disease
- ClinicalTrials.gov ID
- NCT00005985
- Acronym / sponsor ID
- 1996LS155
- Conditions
- Lymphoma
- Keywords
- stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, recurrent adult Hodgkin lymphoma, stage I grade 1 follicular lymphoma, stage I grade 2 follicular lymphoma, stage I grade 3 follicular lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Aug 2000
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 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. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: This phase II trial is studying how well giving filgrastim together with chemotherapy and peripheral stem cell transplant works in treating patients with Hodgkin's lymphoma or non-Hodgkin's lymphoma.
Detailed description
OBJECTIVES:
- Assess the clinical outcomes, survival, and morbidity of transplantation in patients with Hodgkin's lymphoma or non-Hodgkin's lymphoma when treated with filgrastim (G-CSF) followed by high dose chemotherapy plus G-CSF followed by autologous peripheral blood stem cell (PBSC) transplantation.
- Determine whether sufficient PBSC can be collected for use in autologous transplantation in these patients when mobilized with hematopoietic growth factor alone compared to chemotherapy plus growth factor.
- Determine whether these primed PBSC support prompt lymphoid and myeloid hematopoietic recovery after transplantation in these patients.
- Compare the numbers of committed progenitor cells and/or primitive, pluripotential hematopoietic stem cells with these two priming techniques.
- Compare the numbers of tumor cells in cryopreserved PBSC following these priming techniques.
- Evaluate response and extended relapse free survival in conjunction with rapid hematopoietic reconstitution and limited transplant associated morbidity and mortality in these patients when treated with these regimens.
OUTLINE: In the first priming phase, patients receive filgrastim (G-CSF) subcutaneously (SQ) daily on days 1-7 and peripheral blood stem cells are collected on days 6-8.
At least 48 hours after the last dose of G-CSF and after the third leukapheresis, patients receive the second priming, which consists of cyclophosphamide IV over 2 hours on day 1 and cytarabine IV over 1 hour every 12 hours for a total of 2 doses on day 1. Patients also receive mitoxantrone IV over 1 hour daily and dexamethasone IV every 12 hours for a total of 4 doses on days 1-2. Patients receive G-CSF SQ daily beginning on day 4 and continuing until the completion of leukapheresis. PBSC are collected on 3 consecutive days after blood counts recover.
In the transplant phase, patients with non-Hodgkin's lymphoma who have not exceeded pretransplant radiotherapy limits receive cyclophosphamide IV over 2 hours on days -7 and -6 and total body irradiation twice daily on days -4 through -1. Autologous PBSC are reinfused on day 0. Patients receive G-CSF IV daily beginning on day 0 and continuing until day 21 or until blood counts recover.
Patients with Hodgkin's lymphoma or patients with non-Hodgkin's lymphoma who have exceeded pretransplant radiotherapy limits receive cyclophosphamide IV over 2 hours daily on days -6 through -3, carmustine IV over 1 hour on day -6, and etoposide IV over 4 hours every 12 hours for a total of 6 doses on days -6 through -4. Autologous PBSC are reinfused on day 0. Patients also receive G-CSF IV daily beginning on day 0 and continuing until day 21 or until blood counts recover.
All patients receive radiotherapy for any residual nodal masses measuring at least 2 cm 5 days a week beginning on day 28.
Patients are followed at day 100, then every 3 months for 1 year, then every 6 months for 2 years, and then annually thereafter.
This was changed to a treatment guideline study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 70 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 |
|---|---|---|
| filgrastim | Biological | – |
| carmustine | Drug | – |
| cyclophosphamide | Drug | – |
| cytarabine | Drug | – |
| dexamethasone | Drug | – |
| etoposide | Drug | – |
| mitoxantrone hydrochloride | Drug | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Disease-free survival at 2 years
1 secondary outcome
Relapse or progression transplant related mortality at 1½ years
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 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.
Daniel J. Weisdorf, 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 filgrastim, carmustine and cyclophosphamide in people with Lymphoma, 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?
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 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 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?
Disease-free survival at 2 years. 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.