Hodgkin's DiseasePhase 2NCT00797472
Study Comparing R-mabHD and a Combination of ABVD in Hodgkin's Disease
A Phase 2 study testing R-mabHD and ABVD in people with Hodgkin's Disease, run by American Scitech International at 1 site in United States.
Trial summary
120 subjects with Hodgkin's disease will be randomly divided into two groups: Group I receiving R-mabHD and Group II receiving a combination of Adriamycin,Bleomycin,Vinblastine and Dacarbazine. R-mabHD will be given once a week for eight weeks in a row. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hodgkin's Disease
- What is being tested?
- R-mabHD and ABVD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Apr 2014
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must sign an informed consent form
- Must have histologically proven diagnosis of Hodgkin's lymphoma
- Both genders and age between 18 and 65
- Must have adequate bone marrow reserve (ANC.1500/mm3, Platelet>50,000/mm3)
- Must have bidimensionally measureable disease
- LVEF >50% by echocardiogram
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- Serum creatinine upto one fold
- Serum bilirubin upto one fold
- Hepatitis B surface antigen negative
- Hodgkin's Disease patients who relapse after radiation therapy alone or surgical treatment alone or both,or previously untreated patients with stage II bulky, III and IV.
Who cannot join
- HIV positive
- Pregnant women and women of child bearing age who are not practising adequate contraception
- Severe pulmonary disease including COPD and asthma
- Evidence of other malignancy except superficial nonmelanoma skin carcinoma or carcinoma in situ of the cervix
- Nursing mothers
- Uncontrolled active infection
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- concurrent prednisone or other systemic steroid therapy
- Less than 4 weeks since prior radiotherapy
- Less than 30 days since prior investigational therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Raritan Bay Medical Center
Englishtown, New Jersey, 07726
Prem A Nandiwada, M.D., 908-941-5480, rgreywal@americanscitech.com
Ratna Grewal, M.D., 908-941-5480, rgreywal@americanscitech.com
About this study
Official title: A Phase II Open Label, Multicenter, Randomized, Parallel Study Comparing the Efficacy of R-mabHD Alone and a Combination of Adriamycin, Bleomycin, Vinblastine and Dacarbazine (ABVD)in Treating Patients With Hodgkin's Disease.
120 subjects with Hodgkin's disease will be randomly divided into two groups: Group I receiving R-mabHD and Group II receiving a combination of Adriamycin,Bleomycin,Vinblastine and Dacarbazine. R-mabHD will be given once a week for eight weeks in a row. The ABVD combination will be given once every other week for 12 treatments. The hypothesis is that intervention with R-mabHD will lead to a quicker remission of Hodgkin's disease than the intervention with a combination of ABVD.
Read the detailed description
The primary objective is to compare the efficacy of R-mabHD with a combination therapy of Adriamycin, Bleomycin,Vinblastine and Dacarbazine (ABVD) in bringing about remission of Hodgkin's lymphoma and reduction in tumor size.
Primary Study Endpoint: Primary efficacy criterion is percentage of patients achieving a functional score of 1.
Efficacy evaluation is based on assessment of functional score. At the end of six months, a functional assessment of the tumor will be undertaken to record the score as follows:
Score 1: >/= 50% reduction in size of tumor Score 2: < 50% reduction in size of tumor.
Secondary Study Endpoint: Additional secondary endpoint is the average time to achieve 50% reduction in size of tumor.
120 subjects with Hodgkin's Disease will be divided randomly into two groups. 60 subjects (Group I)will receive R-mabHD by intravenous infusion in a dose of 375mg/m2 once a week for eight weeks in a row. The other half (Group II) will receive a combination of intravenous Adriamycin, Bleomycin, Vinblastine and Dacarbazine every other week for 12 treatments. Enrollment period will be three years and subjects from both genders will be accepted. Subjects should be between the ages of 18 and 65. No healthy volunteers will be accepted. Females who are nursing babies or are pregnant will be excluded from the study. Subjects will be evaluated every month for the first six months and then at one year and then at eighteen months after the baseline visit one.
- Conditions
- Hodgkin's Disease
- Being tested
- R-mabHD, ABVD
- Keywords
- Hodgkin's Lymphoma, R-mabHD, ABVD treatment, Hodgkin's Disease
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-mabHDDrug
An intravenous infusion containing R-mabHD 375mg/m2 will be administered over a period of 3 to 8 hours every week for eight weeks in a row.
ABVDDrug
Also called Adriamycin, Bleomycin, Vinblastine, Dacarbazine
A combination of Adriamycin, Bleomycin, Vinblastine and Dacarbazine (ABVD) will be given intravenously over a period of 3 hours every other week for 12 treatments.
| Study group | Role | What they receive |
|---|---|---|
| Arm I: R-mabHD | Active comparator | Anti-hodgkin disease agent Receives: Drug: R-mabHD |
| Arm II: ABVD | Active comparator | Not described Receives: Drug: ABVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
There will be a reduction in the size of the tumor after initiating treatment.
Measured: Six months
Secondary outcomes (1)
There will be an improvement in the general condition of the patient and it will be possible to estimate the event free survival rate.
Measured: Eighteen months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startJul 2011
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin's DiseaseStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Scitech International
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Bristol-Myers Squibb
- Investigators
- Ratna Grewal, M.D., Study chair, American Scitech InternationalPrem A Nandiwada, M.D., Principal investigator, Raritan Bay Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797472
- Sponsor's protocol ID
- ASI-HDII 1108
- Status last verified
- Jul 2011
- First submitted
- 24 Nov 2008
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open Label, Multicenter, Randomized, Parallel Study Comparing the Efficacy of R-mabHD Alone and a Combination of Adriamycin, Bleomycin, Vinblastine and Dacarbazine (ABVD)in Treating Patients With Hodgkin's Disease.
- ClinicalTrials.gov ID
- NCT00797472
- Acronym / sponsor ID
- ASI-HDII 1108
- Conditions
- Hodgkin's Disease
- Keywords
- Hodgkin's Lymphoma, R-mabHD, ABVD treatment, Hodgkin's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- American Scitech InternationalUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Bristol-Myers Squibb
- Study start
- Jul 2011
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 25 Nov 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.
120 subjects with Hodgkin's disease will be randomly divided into two groups: Group I receiving R-mabHD and Group II receiving a combination of Adriamycin,Bleomycin,Vinblastine and Dacarbazine. R-mabHD will be given once a week for eight weeks in a row. The ABVD combination will be given once every other week for 12 treatments. The hypothesis is that intervention with R-mabHD will lead to a quicker remission of Hodgkin's disease than the intervention with a combination of ABVD.
Detailed description
The primary objective is to compare the efficacy of R-mabHD with a combination therapy of Adriamycin, Bleomycin,Vinblastine and Dacarbazine (ABVD) in bringing about remission of Hodgkin's lymphoma and reduction in tumor size.
Primary Study Endpoint: Primary efficacy criterion is percentage of patients achieving a functional score of 1.
Efficacy evaluation is based on assessment of functional score. At the end of six months, a functional assessment of the tumor will be undertaken to record the score as follows:
Score 1: >/= 50% reduction in size of tumor Score 2: < 50% reduction in size of tumor.
Secondary Study Endpoint: Additional secondary endpoint is the average time to achieve 50% reduction in size of tumor.
120 subjects with Hodgkin's Disease will be divided randomly into two groups. 60 subjects (Group I)will receive R-mabHD by intravenous infusion in a dose of 375mg/m2 once a week for eight weeks in a row. The other half (Group II) will receive a combination of intravenous Adriamycin, Bleomycin, Vinblastine and Dacarbazine every other week for 12 treatments. Enrollment period will be three years and subjects from both genders will be accepted. Subjects should be between the ages of 18 and 65. No healthy volunteers will be accepted. Females who are nursing babies or are pregnant will be excluded from the study. Subjects will be evaluated every month for the first six months and then at one year and then at eighteen months after the baseline visit one.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I: R-mabHD | Active comparator | Drug: R-mabHDAnti-hodgkin disease agent |
| Arm II: ABVD | Active comparator | Drug: ABVD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Must sign an informed consent form
- Must have histologically proven diagnosis of Hodgkin's lymphoma
- Both genders and age between 18 and 65
- Must have adequate bone marrow reserve (ANC.1500/mm3, Platelet>50,000/mm3)
- Must have bidimensionally measureable disease
Key exclusion criteria (9 listed)
- HIV positive
- Pregnant women and women of child bearing age who are not practising adequate contraception
- Severe pulmonary disease including COPD and asthma
- Evidence of other malignancy except superficial nonmelanoma skin carcinoma or carcinoma in situ of the cervix
- Nursing mothers
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 |
|---|---|---|
| R-mabHDAn intravenous infusion containing R-mabHD 375mg/m2 will be administered over a period of 3 to 8 hours every week for eight weeks in a row. | Drug | Arm I: R-mabHD |
| ABVDAlso: Adriamycin, Bleomycin, Vinblastine, DacarbazineA combination of Adriamycin, Bleomycin, Vinblastine and Dacarbazine (ABVD) will be given intravenously over a period of 3 hours every other week for 12 treatments. | Drug | Arm II: ABVD |
Primary outcome
There will be a reduction in the size of the tumor after initiating treatment.
Time frame: Six months
1 secondary outcome
There will be an improvement in the general condition of the patient and it will be possible to estimate the event free survival rate.
Time frame: Eighteen months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
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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.
Ratna Grewal, M.D. study chair
American Scitech International
Prem A Nandiwada, M.D. principal investigator
Raritan Bay Medical 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 R-mabHD and ABVD in people with Hodgkin's Disease, run by American Scitech International 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 10 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 20 Jul 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
There will be a reduction in the size of the tumor after initiating treatment. (time frame: Six months). 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 20 Jul 2011.