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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.


Phase 2
18 Years
65 Years
Not Enrolling
Both
Hodgkin's Disease

Thank you

Trial Information

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.


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.


Inclusion Criteria:



1. Must sign an informed consent form

2. Must have histologically proven diagnosis of Hodgkin's lymphoma

3. Both genders and age between 18 and 65

4. Must have adequate bone marrow reserve (ANC.1500/mm3, Platelet>50,000/mm3)

5. Must have bidimensionally measureable disease

6. LVEF >50% by echocardiogram

7. Serum creatinine upto one fold

8. Serum bilirubin upto one fold

9. Hepatitis B surface antigen negative

10. 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:

1. HIV positive

2. Pregnant women and women of child bearing age who are not practising adequate
contraception

3. Severe pulmonary disease including COPD and asthma

4. Evidence of other malignancy except superficial nonmelanoma skin carcinoma or
carcinoma in situ of the cervix

5. Nursing mothers

6. Uncontrolled active infection

7. concurrent prednisone or other systemic steroid therapy

8. Less than 4 weeks since prior radiotherapy

9. Less than 30 days since prior investigational therapy.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

There will be a reduction in the size of the tumor after initiating treatment.

Outcome Time Frame:

Six months

Safety Issue:

Yes

Principal Investigator

Ratna Grewal, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

American Scitech International

Authority:

United States: Institutional Review Board

Study ID:

ASI-HDII 1108

NCT ID:

NCT00797472

Start Date:

July 2011

Completion Date:

April 2014

Related Keywords:

  • Hodgkin's Disease
  • Hodgkin's Lymphoma
  • R-mabHD
  • ABVD treatment
  • Hodgkin's Disease
  • Hodgkin Disease

Name

Location

Raritan Bay Medical CenterPerth Amboy, New Jersey  08861