Study Comparing R-mabHD and a Combination of ABVD in Hodgkin's Disease
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hodgkin's Disease |
Drug: R-mabHD Drug: ABVD |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
- There will be a reduction in the size of the tumor after initiating treatment. [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 120 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I: R-mabHD
Anti-hodgkin disease agent
|
Drug: R-mabHD
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.
Other Name: R-mabHD
|
| Active Comparator: Arm II: ABVD |
Drug: ABVD
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.
Other Name: Adriamycin, Bleomycin, Vinblastine, Dacarbazine
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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
- concurrent prednisone or other systemic steroid therapy
- Less than 4 weeks since prior radiotherapy
- Less than 30 days since prior investigational therapy.
Contacts and Locations| United States, New Jersey | |
| Raritan Bay Medical Center | Not yet recruiting |
| Englishtown, New Jersey, United States, 07726 | |
| Contact: Prem A Nandiwada, M.D. 908-941-5480 rgreywal@americanscitech.com | |
| Contact: Ratna Grewal, M.D. 908-941-5480 rgreywal@americanscitech.com | |
| Study Chair: | Ratna Grewal, M.D. | American Scitech International |
| Principal Investigator: | Prem A Nandiwada, M.D. | Raritan Bay Medical Center |
More Information
No publications provided
| Responsible Party: | Dr. R. Grewal, American Scitech International |
| ClinicalTrials.gov Identifier: | NCT00797472 History of Changes |
| Other Study ID Numbers: | ASI-HDII 1108 |
| Study First Received: | November 24, 2008 |
| Last Updated: | July 19, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by American Scitech International:
|
Hodgkin's Lymphoma R-mabHD ABVD treatment Hodgkin's Disease |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bleomycin Doxorubicin Dacarbazine Vinblastine |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators |
ClinicalTrials.gov processed this record on May 21, 2013