Hodgkin DiseasePhase 3NCT00038558
Prophylactic Use of Filgrastim SD/01 in Patients With Hodgkin's Disease Receiving ABVD Chemotherapy
A Phase 3 study testing Filgrastim SD/01, Adriamycin and Bleomycin in people with Hodgkin Disease, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Prophylactic use of Filgrastim SD/01 for patients with Hodgkin's lymphoma receiving ABVD chemotherapy. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hodgkin Disease
- What is being tested?
- Filgrastim SD/01, Adriamycin and Bleomycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Mar 2005
- Phase
- Phase 3
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Previously untreated Hodgkin's disease patients who are scheduled to receive standard ABVD chemo.
- Histologically proven diagnosis of Hodgkin's disease of any type.
- Bidimensionally measurable disease.
- Signed informed consent.
- Age >/= 16 yrs.
- Adequate bone marrow reserve (ANC>1000/uL, Platelet >100,000/uL.
- LVEF>/=50% by MUGA scan or echocardiogram.
- Serum creatinine <2mg/dL; serum bilirubin<2mg/dL.
Who cannot join
- HIV positive.
- Pregnant women and those of child bearing age who are not using adequate contraception.
- Prior chemotherapy.
- Severe pulmonary disease including COPD and asthma.
- History of prior sensitivity to E.coli derived products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Use of Filgrastim SD/01 In Patients With Hodgkin's Disease Receiving ABVD Chemotherapy
Prophylactic use of Filgrastim SD/01 for patients with Hodgkin's lymphoma receiving ABVD chemotherapy.
- Conditions
- Hodgkin Disease
- Being tested
- Filgrastim SD/01, Adriamycin, Bleomycin, Vinblastine, DTIC
- Keywords
- Hodgkin's lymphoma, Dacarbazine, DTIC, DTIC-Dome, Vinblastine, Velban, Bleomycin sulfate, Blenoxane, BLM, Doxorubicin Hydrochloride, Adriamycin, Filgrastim, G-CSF, Neupogen, Pegfilgrastim, granulocyte colony-stimulating factor
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filgrastim SD/01Drug
Also called G-CSF, Neupogen
AdriamycinDrug
Also called Doxorubicin Hydrochloride, Adriamycin PFS, Adriamycin RDF
BleomycinDrug
Also called Bleomycin sulfate, Blenoxane, BLM
VinblastineDrug
Also called Velban
DTICDrug
Also called DTIC-Dome, Dacarbazine
| Study group | Role | What they receive |
|---|---|---|
| Filgrastim + ABVD Chemotherapy | Experimental | Not described Receives: Drug: Filgrastim SD/01; Drug: Adriamycin; Drug: Bleomycin; Drug: Vinblastine; Drug: DTIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Response to Prophylactic Filgrastim SD/01Chemotherapy
Measured: Following ABVD chemotherapy course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2002 (estimated)
- Study startNov 2001
- Primary completionFeb 2004
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin DiseaseStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anas Younes, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038558
- Sponsor's protocol ID
- ID01-087
- Status last verified
- Oct 2018
- First submitted
- 31 May 2002
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Use of Filgrastim SD/01 In Patients With Hodgkin's Disease Receiving ABVD Chemotherapy
- ClinicalTrials.gov ID
- NCT00038558
- Acronym / sponsor ID
- ID01-087
- Conditions
- Hodgkin Disease
- Keywords
- Hodgkin's lymphoma, Dacarbazine, DTIC, DTIC-Dome, Vinblastine, Velban, Bleomycin sulfate, Blenoxane
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Nov 2001
- Primary completion
- Feb 2004 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 3 Jun 2002 (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.
Prophylactic use of Filgrastim SD/01 for patients with Hodgkin's lymphoma receiving ABVD chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Filgrastim + ABVD Chemotherapy | Experimental | Drug: Filgrastim SD/01, Drug: Adriamycin, Drug: Bleomycin, Drug: Vinblastine, Drug: DTIC |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Previously untreated Hodgkin's disease patients who are scheduled to receive standard ABVD chemo.
- Histologically proven diagnosis of Hodgkin's disease of any type.
- Bidimensionally measurable disease.
- Signed informed consent.
- Age >/= 16 yrs.
Key exclusion criteria (5 listed)
- HIV positive.
- Pregnant women and those of child bearing age who are not using adequate contraception.
- Prior chemotherapy.
- Severe pulmonary disease including COPD and asthma.
- History of prior sensitivity to E.coli derived products.
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 SD/01Also: G-CSF, Neupogen | Drug | Filgrastim + ABVD Chemotherapy |
| AdriamycinAlso: Doxorubicin Hydrochloride, Adriamycin PFS, Adriamycin RDF | Drug | Filgrastim + ABVD Chemotherapy |
| BleomycinAlso: Bleomycin sulfate, Blenoxane, BLM | Drug | Filgrastim + ABVD Chemotherapy |
| VinblastineAlso: Velban | Drug | Filgrastim + ABVD Chemotherapy |
| DTICAlso: DTIC-Dome, Dacarbazine | Drug | Filgrastim + ABVD Chemotherapy |
Primary outcome
Number of Patients with Response to Prophylactic Filgrastim SD/01Chemotherapy
Time frame: Following ABVD chemotherapy course
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 31 Oct 2018.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
Related trials for Hodgkin Disease
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingPhase 2
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
Mycosis Fungoides, Lymphomatoid Papulosis
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.
Anas Younes, MD principal investigator
UT MD Anderson 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 3 study testing Filgrastim SD/01, Adriamycin and Bleomycin in people with Hodgkin Disease, run by M.D. Anderson 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?
The sponsor lists 8 inclusion and 5 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: finished, as of the sponsor's last update on 31 Oct 2018. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Number of Patients with Response to Prophylactic Filgrastim SD/01Chemotherapy (time frame: Following ABVD chemotherapy course). 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 31 Oct 2018.