LymphomaPhase 2NCT00723658
S0629, Observation or Combination Chemotherapy, Bortezomib, Thalidomide, and Rituximab Followed By Two Autologous Peripheral Blood Stem Cell Transplants in Treating Patients With Waldenstrom Macroglobulinemia
A Phase 2 study testing rituximab, bortezomib and carmustine in people with Lymphoma, run by SWOG Cancer Research Network at 29 sites in United States.
Trial summary
RATIONALE: Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. Giving combination chemotherapy together with bortezomib, thalidomide, and rituximab before an autologous peripheral stem cell transplant stops the growth of cancer cells by stopping them from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- rituximab, bortezomib and carmustine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 29 sitesUnited States
- Study dates
- Sep 2008to May 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of Waldenstrom macroglobulinemia (WM)
- Measurable disease as determined by IgM protein quantification
- Must be registered to the treatment portion of the study within 28 days of experiencing disease-related symptoms* AND must present with ≥ 1 of the following disease-related symptoms:
- Hemoglobin ≤ 11 g/dL
- Platelet count ≤ 100,000/mm³
- Marked tumor mass, defined as lymphadenopathy > 2 cm, palpable hepatomegaly, splenomegaly, or significant marrow involvement (> 50%)
- Serum albumin < 2.5 g/dL
- Persistently elevated beta-2-microglobulin > 3.0 mg/L in the absence of renal impairment or active infections
- Presence of B symptoms (i.e., fever, night sweats, or weight loss of > 10% from baseline)
- Appearance of new or worsening neuropathy manifested by numbness and tingling or pain
- Symptomatic cryoglobulinemia (i.e., Raynaud phenomenon, skin ulcers, cold urticaria, or skin necrosis)
- Symptoms of hyperviscosity, if measured viscosity > 4 cp (i.e., new headaches, vertigo, ataxia, dizziness with or without evident causes of changes in funduscopic exam, including retinal vein engorgement, hemorrhages, or exudates)
- NOTE: *Appearance of any of the above symptoms caused by WM with no other obvious cause is a trigger for treatment initiation. Symptoms need not persist for any specified time frame.
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-2 (Zubrod performance status 3 allowed provided it is based solely on morbidity due to WM)
- ANC > 1,500/mm³ (unless more marked cytopenias can be explained by marked marrow involvement or autoimmune myelosuppression)
- Serum creatinine < 3 mg/dL
- Creatinine clearance > 30 mL/min
- SGOT/SGPT < 2 times upper limit of normal
- Direct bilirubin < 2.0 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception according to the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.®) program
- Ejection fraction ≥ 50% by ECHO or MUGA scan
- Patients with evidence of amyloidosis (i.e., periorbital perforation, proteinuria not attributable to Bence-Jones protein, unexplained arrhythmias, increased liver function tests, peripheral neuropathy, carpal tunnel syndrome, and/or macroglossia) must have an ECHO, rather than MUGA, performed to evaluate for cardiac amyloidosis (septal thickness, diastolic dysfunction, granular sparkling, or low-voltage QRS complexes)
- No myocardial infarction within the past 6 months
- No unstable angina
- No difficult-to-control congestive heart failure or cardiac arrhythmias
- No uncontrolled hypertension
- No peripheral neuropathy ≥ grade 2
- No history of multi-infarced dementia or multiple strokes
- No known hypersensitivity to boron or mannitol
- No hepatitis B or C positivity
- No HIV positivity
- No other prior malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
- At least 28 days since prior chemotherapy and/or radiotherapy and recovered
- No prior bortezomib
- No concurrent glucocorticoids unless used to control autoimmune disease associated with WM
- Concurrent participation in the Myeloma Specimen Repository study allowed
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, 48106-0995
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, 46107
Grandview Hospital
Dayton, Ohio, 45405
Good Samaritan Hospital
Dayton, Ohio, 45406
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, 45409
CCOP - Dayton
Dayton, Ohio, 45420
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, 48123-2500
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
Blanchard Valley Medical Associates
Findlay, Ohio, 45840
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Hurley Medical Center
Flint, Michigan, 48503
Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, 48236
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06105
Foote Memorial Hospital
Jackson, Michigan, 49201
Charles F. Kettering Memorial Hospital
Kettering, Ohio, 45429
Sparrow Regional Cancer Center
Lansing, Michigan, 48912-1811
Lawrence Memorial Hospital
Lawrence, Kansas, 66044
St. Mary Mercy Hospital
Livonia, Michigan, 48154
St. Joseph Mercy Oakland
Pontiac, Michigan, 48341-2985
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, 48060
Reid Hospital & Health Care Services
Richmond, Indiana, 47374
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, 48601
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, 45373-1300
St. John Macomb Hospital
Warren, Michigan, 48093
Wesley Medical Center
Wichita, Kansas, 67214
Clinton Memorial Hospital
Wilmington, Ohio, 45177
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, 45385
About this study
Official title: S0629, Observational Study of Asymptomatic Waldenstrom's Macroglobulinemia and Phase II Study of Tandem Autologous Transplant and Maintenance Treatment for Patients With Symptomatic Disease
RATIONALE: Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. Giving combination chemotherapy together with bortezomib, thalidomide, and rituximab before an autologous peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
PURPOSE: This observational and phase II trial is studying how well giving combination chemotherapy together with bortezomib, thalidomide, and rituximab followed by two autologous peripheral blood stem cell transplants works in treating patients with Waldenstrom macroglobulinemia.
Read the detailed description
OBJECTIVES:
Primary
- To assess the progression-free and overall survival of patients with symptomatic Waldenstrom macroglobulinemia treated with bortezomib, dexamethasone, thalidomide, cisplatin, doxorubicin hydrochloride, cyclophosphamide, and etoposide (VDT-PACE) in combination with rituximab, followed by single or tandem autologous peripheral blood stem cell transplantation and maintenance therapy.
- To assess the confirmed and unconfirmed response in patients treated with this regimen.
Secondary
- To evaluate the feasibility and toxicity of this regimen in these patients.
- To correlate the time to symptom development and overall survival with standard prognostic factors and cytopenias.
- To examine the natural history of Waldenstrom macroglobulinemia.
- To identify, in a preliminary fashion, biological correlates that may relate to progression or to symptomatic disease.
OUTLINE: This is a multicenter study. Patients with asymptomatic disease at study entry proceed directly to observation. Patients with symptomatic disease at study entry proceed directly to induction therapy.
- Observation: Patients with asymptomatic disease undergo observation monthly for 3 months and then every 3 months for up to 3 years. Patients who develop symptomatic disease proceed to induction therapy within 28 days of onset of disease symptoms. Patients who continue to have asymptomatic disease after 3 years of observation are removed from the study.
- Induction therapy: Patients receive oral dexamethasone and oral thalidomide on days 1-4; cisplatin IV, doxorubicin hydrochloride IV, cyclophosphamide IV, and etoposide IV continuously on days 1-4; bortezomib IV on days 1, 4, 8, and 11; and rituximab IV on days 1, 8, and 15. Treatment repeats every 6-8 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
- Peripheral blood stem cell (PBSC) collection: Patients receive filgrastim (G-CSF) IV beginning on day 9 of course 1 of induction therapy and continuing until WBC counts are adequate for apheresis. Patients also receive G-CSF IV beginning on day 6 of course 2 of induction therapy and continuing until apheresis is complete.
- First autologous PBSC transplantation*: Beginning approximately 4-6 weeks after the completion of induction therapy, patients receive conditioning therapy comprising high-dose melphalan IV and bortezomib IV on days -4 and -1. Patients undergo autologous PBSC transplantation on day 0 NOTE: *Patients who will receive a single transplant (for medical, insurance, or other reasons) will not receive melphalan and bortezomib, but will receive conditioning with carmustine, etoposide, cytarabine, and melphalan (BEAM) and will proceed to Maintenance Therapy.
- Second autologous PBSC transplantation: Beginning approximately 56-90 days after the first transplant, patients receive conditioning therapy comprising carmustine IV over 2 hours on day -5; etoposide IV over 1 hour and cytarabine IV over 1 hour on days -5 to -2; and melphalan IV on day -1. Patients undergo autologous PBSC transplantation on day 0.
- Maintenance therapy: Beginning after platelet counts recover, patients receive bortezomib IV on days 1, 4, 8, and 11 and rituximab IV over 2 hours on day 11. Treatment repeats every 3 months for 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months for up to 5 years.
- Conditions
- Lymphoma
- Being tested
- rituximab, bortezomib, carmustine, cisplatin, cyclophosphamide
- Keywords
- Waldenström macroglobulinemia
- Medical subject headings
- Lymphoma, Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabBiological
bortezomibDrug
carmustineDrug
cisplatinDrug
cyclophosphamideDrug
cytarabineDrug
dexamethasoneDrug
etoposideDrug
melphalanDrug
thalidomideDrug
autologous-autologous tandem hematopoietic stem cell transplantationProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Observation | No intervention | Non-symptomatic patients are monitored monthly for 3 months, then every 3 months thereafter. |
| Treatment | Experimental | Symptomatic pts: 2 cycles VTDPACE+R:
dex 40 mg PO D1-4 thalid 200 mg PO D1-4 cisplatin 10 mg/m2 IV D1-4 dox 10 mg/m2 IV D1-4 cyclophos 400 mg/m2 IV D1-4 etoposide 40 mg/m2 IV D1-4 bortezomib 1.0 mg/m2 IV D1,4,8,11 ritux 375 mg/m2 IV D1,8,15 lovenox 40 mg/d SQ D1-platelets >50,000/mcl GCSF 10 mcg/kg/d IV D9-WBC <2,000/mcl apheresis >/= 20x10^6 when WBC and CD34 within normal range, up to 4 cycles
1. st Trans: mel 200 mg/m2 IV D-1 bortezomib 1.3 mg/m2 IV D-4, -1 PBSC >/=3.0x10^6/kg CD34 cells IV D0 GCSF 5 mcg/kg/d SQ D6-WBC recovery D5NS 500 ml IV D-1 dex 40 mg/d PO D-4 to -1 ondansetron 24 mg OR granisetron 2 mg PO D-1
2. nd Trans: BCNU 300 mg/m2 IV D-5 etoposide 200 mg/m2 IV D-5 to -2 AraC 400 mg/m2 IV D-5 to -2 mel 140 mg/m2 IV D-1 PBSC infusion >/=3.0x10^6/kg CD34 cells IV D0 GCSF 5 mcg/kg/d SQ D6-WBC recovery D5NS 150 ml/hr IV D-5 to -1 dex 40 mg/d PO D-4 to -1 ondansetron 24 mg OR granisetron 2 mg PO D-1 Receives: Biological: rituximab; Drug: bortezomib; Drug: carmustine; Drug: cisplatin; Drug: cyclophosphamide; Drug: cytarabine; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: melphalan; Drug: thalidomide; Procedure: autologous-autologous tandem hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival at 3 years
Measured: 3 years
Secondary outcomes (4)
Overall survival
Measured: 3 years
Response rate (complete response, very good partial response, and partial response)
Measured: 3 years
Standard prognostic factors and other potential correlates that may relate to progression, symptomatic disease, and/or survival
Measured: 3 years
Toxicity
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startSep 2008
- Primary completionMay 2010
Why it stopped: lack of accrual
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 SWOG Cancer Research NetworkThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gordan Srkalovic, MD, PhD, Study chair, Sparrow Regional Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723658
- Sponsor's protocol ID
- S0629
- Other IDs
- S0629, U10CA032102
- Status last verified
- Mar 2015
- First submitted
- 26 Jul 2008
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S0629, Observational Study of Asymptomatic Waldenstrom's Macroglobulinemia and Phase II Study of Tandem Autologous Transplant and Maintenance Treatment for Patients With Symptomatic Disease
- ClinicalTrials.gov ID
- NCT00723658
- Acronym / sponsor ID
- S0629
- Conditions
- Lymphoma
- Keywords
- Waldenström macroglobulinemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2008
- Primary completion
- May 2010 (actual)
- First posted
- 29 Jul 2008 (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: Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. Giving combination chemotherapy together with bortezomib, thalidomide, and rituximab before an autologous peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
PURPOSE: This observational and phase II trial is studying how well giving combination chemotherapy together with bortezomib, thalidomide, and rituximab followed by two autologous peripheral blood stem cell transplants works in treating patients with Waldenstrom macroglobulinemia.
Detailed description
OBJECTIVES:
Primary
- To assess the progression-free and overall survival of patients with symptomatic Waldenstrom macroglobulinemia treated with bortezomib, dexamethasone, thalidomide, cisplatin, doxorubicin hydrochloride, cyclophosphamide, and etoposide (VDT-PACE) in combination with rituximab, followed by single or tandem autologous peripheral blood stem cell transplantation and maintenance therapy.
- To assess the confirmed and unconfirmed response in patients treated with this regimen.
Secondary
- To evaluate the feasibility and toxicity of this regimen in these patients.
- To correlate the time to symptom development and overall survival with standard prognostic factors and cytopenias.
- To examine the natural history of Waldenstrom macroglobulinemia.
- To identify, in a preliminary fashion, biological correlates that may relate to progression or to symptomatic disease.
OUTLINE: This is a multicenter study. Patients with asymptomatic disease at study entry proceed directly to observation. Patients with symptomatic disease at study entry proceed directly to induction therapy.
- Observation: Patients with asymptomatic disease undergo observation monthly for 3 months and then every 3 months for up to 3 years. Patients who develop symptomatic disease proceed to induction therapy within 28 days of onset of disease symptoms. Patients who continue to have asymptomatic disease after 3 years of observation are removed from the study.
- Induction therapy: Patients receive oral dexamethasone and oral thalidomide on days 1-4; cisplatin IV, doxorubicin hydrochloride IV, cyclophosphamide IV, and etoposide IV continuously on days 1-4; bortezomib IV on days 1, 4, 8, and 11; and rituximab IV on days 1, 8, and 15. Treatment repeats every 6-8 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
- Peripheral blood stem cell (PBSC) collection: Patients receive filgrastim (G-CSF) IV beginning on day 9 of course 1 of induction therapy and continuing until WBC counts are adequate for apheresis. Patients also receive G-CSF IV beginning on day 6 of course 2 of induction therapy and continuing until apheresis is complete.
- First autologous PBSC transplantation*: Beginning approximately 4-6 weeks after the completion of induction therapy, patients receive conditioning therapy comprising high-dose melphalan IV and bortezomib IV on days -4 and -1. Patients undergo autologous PBSC transplantation on day 0 NOTE: *Patients who will receive a single transplant (for medical, insurance, or other reasons) will not receive melphalan and bortezomib, but will receive conditioning with carmustine, etoposide, cytarabine, and melphalan (BEAM) and will proceed to Maintenance Therapy.
- Second autologous PBSC transplantation: Beginning approximately 56-90 days after the first transplant, patients receive conditioning therapy comprising carmustine IV over 2 hours on day -5; etoposide IV over 1 hour and cytarabine IV over 1 hour on days -5 to -2; and melphalan IV on day -1. Patients undergo autologous PBSC transplantation on day 0.
- Maintenance therapy: Beginning after platelet counts recover, patients receive bortezomib IV on days 1, 4, 8, and 11 and rituximab IV over 2 hours on day 11. Treatment repeats every 3 months for 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months for up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation | No intervention | –Non-symptomatic patients are monitored monthly for 3 months, then every 3 months thereafter. |
| Treatment | Experimental | Biological: rituximab, Drug: bortezomib, Drug: carmustine, Drug: cisplatin, Drug: cyclophosphamide, Drug: cytarabine, Drug: dexamethasone, Drug: doxorubicin hydrochloride, Drug: etoposide, Drug: melphalan, Drug: thalidomide, Procedure: autologous-autologous tandem hematopoietic stem cell transplantation, Procedure: peripheral blood stem cell transplantationSymptomatic pts: 2 cycles VTDPACE+R: dex 40 mg PO D1-4 thalid 200 mg PO D1-4 cisplatin 10 mg/m2 IV D1-4 dox 10 mg/m2 IV D1-4 cyclophos 400 mg/m2 IV D1-4 etoposide 40 mg/m2 IV D1-4 bortezomib 1.0 mg/m2 IV D1,4,8,11 ritux 375 mg/m2 IV D1,8,15 lovenox 40 mg/d SQ D1-platelets >50,000/mcl GCSF 10 mcg/kg/d IV D9-WBC <2,000/mcl apheresis >/= 20x10^6 when WBC and CD34 within normal range, up to 4 cycles 1. st Trans: mel 200 mg/m2 IV D-1 bortezomib 1.3 mg/m2 IV D-4, -1 PBSC >/=3.0x10^6/kg CD34 cells IV D0 GCSF 5 mcg/kg/d SQ D6-WBC recovery D5NS 500 ml IV D-1 dex 40 mg/d PO D-4 to -1 ondansetron 24 mg OR granisetron 2 mg PO D-1 2. nd Trans: BCNU 300 mg/m2 IV D-5 etoposide 200 mg/m2 IV D-5 to -2 AraC 400 mg/m2 IV D-5 to -2 mel 140 mg/m2 IV D-1 PBSC infusion >/=3.0x10^6/kg CD34 cells IV D0 GCSF 5 mcg/kg/d SQ D6-WBC recovery D5NS 150 ml/hr IV D-5 to -1 dex 40 mg/d PO D-4 to -1 ondansetron 24 mg OR granisetron 2 mg PO D-1 |
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| rituximab | Biological | Treatment |
| bortezomib | Drug | Treatment |
| carmustine | Drug | Treatment |
| cisplatin | Drug | Treatment |
| cyclophosphamide | Drug | Treatment |
| cytarabine | Drug | Treatment |
| dexamethasone | Drug | Treatment |
| doxorubicin hydrochloride | Drug | Treatment |
| etoposide | Drug | Treatment |
| melphalan | Drug | Treatment |
| thalidomide | Drug | Treatment |
| autologous-autologous tandem hematopoietic stem cell transplantation | Procedure or surgery | Treatment |
| peripheral blood stem cell transplantation | Procedure or surgery | Treatment |
Primary outcome
Progression-free survival at 3 years
Time frame: 3 years
4 secondary outcomes
Overall survival
Time frame: 3 years
Response rate (complete response, very good partial response, and partial response)
Time frame: 3 years
Standard prognostic factors and other potential correlates that may relate to progression, symptomatic disease, and/or survival
Time frame: 3 years
Toxicity
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
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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.
Gordan Srkalovic, MD, PhD study chair
Sparrow Regional Cancer Center
29 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 rituximab, bortezomib and carmustine in people with Lymphoma, run by SWOG Cancer Research Network at 29 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: withdrawn, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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 was withdrawn before enrolling participants, so there are no results.
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?
Progression-free survival at 3 years (time frame: 3 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 6 Mar 2015.