LymphomaPhase 2NCT00504504
Rituximab and ABVD for Hodgkin's Patients
A Phase 2 study testing Rituximab, Adriamycin and Bleomycin in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective: To determine the feasibility, toxicity, and efficacy of Rituximab with standard dose ABVD combination chemotherapy. ABVD combination chemotherapy consists of Adriamycin, Bleomycin, Vinblastine and DTIC. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Rituximab, Adriamycin and Bleomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2001to Mar 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Hodgkin's disease patients who relapse after radiation therapy alone and previously untreated patients with stage II bulky, III and IV who are eligible for ABVD.
- Must have histologically proven diagnosis of Hodgkin's disease (Nodular sclerosis or mixed cellularity).
- Must have bidimensionally measurable disease.
- Must sign a consent form.
- Must be older than 16 years of age.
- Must have adequate bone marrow reserve (ANC > 1,000/microL, Platelet > 100,000/microL
- Left Ventricular Ejection Fraction (LVEF) >/= 50% by multigated acquisition (MUGA) scan or echocardiogram.
- Serum creatinine < 2 mg/dl, serum bilirubin < 2 mg/dl
Who cannot join
- HIV positive.
- Pregnant women and women of child bearing age who are not practicing adequate contraception.
- Prior chemotherapy.
- Severe pulmonary disease including Chronic obstructive pulmonary disease (COPD) and asthma.
Trial locations and contacts
1 site in 1 country.
United States1 site
UT MD . Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase II Study of Rituximab + ABVD for Patients With Hodgkin's Disease
Primary Objective:
- To determine the feasibility, toxicity, and efficacy of Rituximab with standard dose ABVD combination chemotherapy.
ABVD combination chemotherapy consists of Adriamycin, Bleomycin, Vinblastine and DTIC.
Read the detailed description
Before treatment starts, patients will have a physical exam. Bone marrow samples will be taken. Blood samples (4 to 8 tablespoons) will be taken before and during the study. A chest x-ray, CT scans of the abdomen and pelvis, and a gallium scan will be done if necessary.
Patients in this study will receive rituximab by vein over 3 to 8 hours weekly for 6 weeks in a row. ABVD will be injected over 3 hours every other week for a total of 12 treatments. On the cycles where both rituximab and ABVD are given, rituximab will be given on day 1, and ABVD will be given on day 2. Response to therapy will be determined after 3 months and at the end of therapy (6 months). At the end, patients may receive radiation therapy to areas of large masses. All treatments can be given in an outpatient setting.
Scans and x-rays will be repeated if needed after completion of therapy and every 3 months from then on. If tumors do not shrink after 3 months of therapy, patients will be offered a different treatment.
This is an investigational study. Although ABVD is considered the standard treatment for patients with Hodgkin's disease, the combination of ABVD with rituximab is considered investigational. All drugs involved in this study are commercially available and are approved by the FDA. Up to 85 patients will take part in this study. All will be enrolled at M. D. Anderson. This protocol is partially funded by a research grant from Genentech.
- Conditions
- Lymphoma
- Being tested
- Rituximab, Adriamycin, Bleomycin, Vinblastine, Dacarbazine (DTIC)
- Keywords
- Hodgkin's Disease, Lymphoma, Rituximab, Rituxan, Adriamycin, Doxorubicin, Rubex, Bleomycin, Bleomycin sulfate, Blenoxane, BLM, Dacarbazine, DTIC, DTIC-Dome, Vincristine, Vinblastine, Vinblastine Sulfate, ABVD, ABVD Chemotherapy Treatment
- Medical subject headings
- Lymphoma, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Rituxan
375 mg/m^2 by vein over 3 to 8 hours weekly for 6 weeks in a row.
AdriamycinDrug
Also called Doxorubicin, Rubex
25 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
BleomycinDrug
Also called Bleomycin sulfate, Blenoxane, BLM
10 U/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
VinblastineDrug
Also called Vinblastine Sulfate, Velban
6 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
Dacarbazine (DTIC)Drug
Also called DTIC-Dome
375 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
| Study group | Role | What they receive |
|---|---|---|
| Rituximab + ABVD Chemotherapy | Experimental | Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments. Receives: Drug: Rituximab; Drug: Adriamycin; Drug: Bleomycin; Drug: Vinblastine; Drug: Dacarbazine (DTIC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD
Five year Event Free Survival (EFS) is proportion of surviving participants who remain event free out of total participants at 5 years after receiving Rituximab + ABVD (RABVD). Event-free Survival (EFS) analyzed every 6 months.
Measured: Baseline to 5 Years or until disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study startMar 2001
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Anas Younes, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504504
- Sponsor's protocol ID
- ID00-218
- Status last verified
- May 2013
- First submitted
- 19 Jul 2007
- Last updated
- 9 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Younes A, Oki Y, McLaughlin P, Copeland AR, Goy A, Pro B, Feng L, Yuan Y, Chuang HH, Macapinlac HA, Hagemeister F, Romaguera J, Samaniego F, Fanale MA, Dabaja BS, Rodriguez MA, Dang N, Kwak LW, Neelapu SS, Fayad LE. Phase 2 study of rituximab plus ABVD in patients with newly diagnosed classical Hodgkin lymphoma. Blood. 2012 May 3;119(18):4123-8. doi: 10.1182/blood-2012-01-405456. Epub 2012 Feb 27.
PubMed 22371887
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Rituximab + ABVD for Patients With Hodgkin's Disease
- ClinicalTrials.gov ID
- NCT00504504
- Acronym / sponsor ID
- ID00-218
- Conditions
- Lymphoma
- Keywords
- Hodgkin's Disease, Lymphoma, Rituximab, Rituxan, Adriamycin, Doxorubicin, Rubex, Bleomycin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Mar 2001
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 20 Jul 2007 (estimated)
- Results
- Posted 9 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- To determine the feasibility, toxicity, and efficacy of Rituximab with standard dose ABVD combination chemotherapy.
ABVD combination chemotherapy consists of Adriamycin, Bleomycin, Vinblastine and DTIC.
Detailed description
Before treatment starts, patients will have a physical exam. Bone marrow samples will be taken. Blood samples (4 to 8 tablespoons) will be taken before and during the study. A chest x-ray, CT scans of the abdomen and pelvis, and a gallium scan will be done if necessary.
Patients in this study will receive rituximab by vein over 3 to 8 hours weekly for 6 weeks in a row. ABVD will be injected over 3 hours every other week for a total of 12 treatments. On the cycles where both rituximab and ABVD are given, rituximab will be given on day 1, and ABVD will be given on day 2. Response to therapy will be determined after 3 months and at the end of therapy (6 months). At the end, patients may receive radiation therapy to areas of large masses. All treatments can be given in an outpatient setting.
Scans and x-rays will be repeated if needed after completion of therapy and every 3 months from then on. If tumors do not shrink after 3 months of therapy, patients will be offered a different treatment.
This is an investigational study. Although ABVD is considered the standard treatment for patients with Hodgkin's disease, the combination of ABVD with rituximab is considered investigational. All drugs involved in this study are commercially available and are approved by the FDA. Up to 85 patients will take part in this study. All will be enrolled at M. D. Anderson. This protocol is partially funded by a research grant from Genentech.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab + ABVD Chemotherapy | Experimental | Drug: Rituximab, Drug: Adriamycin, Drug: Bleomycin, Drug: Vinblastine, Drug: Dacarbazine (DTIC)Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments. |
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)
- Hodgkin's disease patients who relapse after radiation therapy alone and previously untreated patients with stage II bulky, III and IV who are eligible for ABVD.
- Must have histologically proven diagnosis of Hodgkin's disease (Nodular sclerosis or mixed cellularity).
- Must have bidimensionally measurable disease.
- Must sign a consent form.
- Must be older than 16 years of age.
Key exclusion criteria (4 listed)
- HIV positive.
- Pregnant women and women of child bearing age who are not practicing adequate contraception.
- Prior chemotherapy.
- Severe pulmonary disease including Chronic obstructive pulmonary disease (COPD) and asthma.
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 |
|---|---|---|
| RituximabAlso: Rituxan375 mg/m^2 by vein over 3 to 8 hours weekly for 6 weeks in a row. | Drug | Rituximab + ABVD Chemotherapy |
| AdriamycinAlso: Doxorubicin, Rubex25 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments. | Drug | Rituximab + ABVD Chemotherapy |
| BleomycinAlso: Bleomycin sulfate, Blenoxane, BLM10 U/m^2 injected by vein over 3 hours every other week for a total of 12 treatments. | Drug | Rituximab + ABVD Chemotherapy |
| VinblastineAlso: Vinblastine Sulfate, Velban6 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments. | Drug | Rituximab + ABVD Chemotherapy |
| Dacarbazine (DTIC)Also: DTIC-Dome375 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments. | Drug | Rituximab + ABVD Chemotherapy |
Primary outcome
5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD
Time frame: Baseline to 5 Years or until disease progression
Five year Event Free Survival (EFS) is proportion of surviving participants who remain event free out of total participants at 5 years after receiving Rituximab + ABVD (RABVD). Event-free Survival (EFS) analyzed every 6 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22371887Younes A, Oki Y, McLaughlin P, Copeland AR, Goy A, Pro B, Feng L, Yuan Y, Chuang HH, Macapinlac HA, Hagemeister F, Romaguera J, Samaniego F, Fanale MA, Dabaja BS, Rodriguez MA, Dang N, Kwak LW, Neelapu SS, Fayad LE. Phase 2 study of rituximab plus ABVD in patients with newly diagnosed classical Hodgkin lymphoma. Blood. 2012 May 3;119(18):4123-8. doi: 10.1182/blood-2012-01-405456. Epub 2012 Feb 27.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Anas Younes, MD principal investigator
M.D. 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 2 study testing Rituximab, Adriamycin and Bleomycin in people with Lymphoma, 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 4 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 9 Jul 2013. 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?
Yes. Results are posted in the registry (first posted 9 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD (time frame: Baseline to 5 Years or until disease progression). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00504504, which also lists 1 linked publication.
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 9 Jul 2013.