Study Evaluating the Effect of R-mabHDI in Lymphocytic Predominant Hodgkin's Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by American Scitech International.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
ImClone LLC
Bristol-Myers Squibb
Information provided by:
American Scitech International
ClinicalTrials.gov Identifier:
NCT00816959
First received: January 5, 2009
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

Objective:

The primary objective of the study is to evaluate the effect of R-mabHDI in patients with late stage, widespread stage and recurrent Lymphocytic Predominant Hodgkin's Lymphoma.

The hypothesis is that the combination of R-mabHDI with the standard ABVD therapy in patients with late stage (Stage III and Stage IV) and recurrent stage Lymphocytic Predominant Hodgkin's Lymphoma will have a favorable outcome on the response and progress free survival. The study is also aimed at evaluating the safety of R-mabHDI .

The aim of the study is to test this hypothesis by evaluating the clinical outcome in 1200 patients receiving combination of R-mabHDI once a week for 8 weeks and ABVD therapy every other week for 12 treatments.


Condition Intervention Phase
Hodgkin's Lymphoma
Drug: R-mabHDI and ABVD
Drug: ABVD
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Randomized, Multi-center Study to Evaluate the Effect of R-mabHDI in Patients With Lymphocytic Predominant Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by American Scitech International:

Primary Outcome Measures:
  • The primary efficacy criterion is the response rates (RR) by Kaplan-Meier at 3,6,12, and 18 months. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Additional secondary endpoint criterion is the progress free survival (PFS) by Kaplan-Meier at 18 months. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1200
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-mabHDI and ABVD Drug: R-mabHDI and ABVD

The subjects will receive R-mabHDI intravenously, separately for about 7 hours on days 1,8,15 and 22 (once a week) of every cycle. Each cycle is 4 weeks. R-mabHDI will be given for 2 cycles.

Also the subjects will receive the ABVD combination intravenously for about 1 hour on day 1 and 15 of every cycle (every 2 weeks). Each cycle is 4 weeks. ABVD will be given for 6 cycles.

Other Name: R-mabHDI
Active Comparator: Arm II: ABVD Drug: ABVD
The subjects will receive the ABVD combination intravenously for about 1 hour on day 1 and 15 of every cycle (every 2 weeks). Each cycle is 4 weeks. ABVD will be given for 6 cycles.
Other Name: Adriamycin, Bleomycin, Vinblastine and Dacarbazine

Detailed Description:

The primary objective of the study is to evaluate the effect of R-mabHDI in Patients with late stage, widespread stage and recurrent Lymphocytic Predominant Hodgkin's Lymphoma.

The hypothesis is that the combination of R-mabHDI with the standard ABVD therapy in patients with late stage (Stage III and Stage IV) and recurrent stage Lymphocytic Predominant Hodgkin's Lymphoma will have a favorable outcome on the response and progress free survival. The study is also aimed at evaluating the safety of R-mabHDI .

A total of 1200 subjects will be recruited to the study from various centers. Enrollment period will last for up to one and half year and treatment period is for six months. Treatment will be considered a failure if the tumor size and signs of LPHD does not decrease after 3 months.

Subjects having late stage HD, widespread HD or recurrent HD fulfilling the inclusion and exclusion criteria will be recruited in this study. Females who are nursing babies or are pregnant will be excluded from the study.

All subjects will receive the drugs according to the randomization process. The eligible subjects will be randomly assigned to 1 of 2 "treatment" groups after screening. No matter which group the subjects are assigned to, the doses of the drugs will be the standard doses that are currently used to treat lymphoma.

Group 1: subjects assigned to group 1 will receive the ABVD combination intravenously for about 1 hour on day 1 and 15 of every cycle (every 2 weeks). Each cycle is 4 weeks. ABVD will to be given for 6 cycles.

The subjects will also receive R-mabHDI intravenously, separately for about 7 hours on days 1,8,15 and 22 (once a week) of every cycle. Each cycle is 4 weeks. R-mabHDI will be given for 2 cycles.

Group 2: subjects assigned to group 2 will receive the ABVD combination intravenously for about 1 hour on day 1 and 15 of every cycle (every 2 weeks). Each cycle is 4 weeks. ABVD will to be given for 6 cycles.

Subjects in group 2 will not receive R-mabHDI .

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must sign the informed consent form
  • Patients with proven diagnosis of Lymphocytic Predominant Hodgkin's Lymphoma in late stage HD, widespread HD and recurrent HD on histology.
  • Patients of both gender
  • Patients between ages of 16 and 65 years
  • Patients must have bi-dimensionally measurable disease
  • Patients with adequate bone marrow reserve (ANC>1500/mm3 ; Platelets> 50,000/ mm3)
  • LVEF >/= 50% as measured by echocardiogram
  • Serum creatinine < 2mg/dl
  • Serum bilirubin < 2mg/dl; AST or ALT < 2x ULN
  • International Prognostic Score of >2 (Patients must have > 2 of the following risk features: Male >/= 45 years of age, Stage IV, Albumin <4, WBC >/= 15, Lymphocytes < 8% or < 600, Hb < 10.5)

Exclusion Criteria:

  • Classic Hodgkin's disease
  • Known HIV infection
  • Pregnant women and women of child bearing capacity, tests positive on a urine/blood pregnancy test, is lactating/nursing, has had three or more days of amenorrhea at the time of first dose of the treatment, is contemplating pregnancy in next six months or is not using an efficient contraceptive method.
  • Severe pulmonary disease as judged by the Principal Investigator including COPD and asthma
  • Acute infection requiring treatment with intravenous therapy
  • Presence of CNS lymphoma
  • Concomitant malignancies or previous malignancies within the last 5 years
  • Active Hepatitis B or C infection
  • Uncontrolled active infection
  • Concurrent prednisone or systemic steroid therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816959

Contacts
Contact: Ratna Grewal, MD 908-941-5480 rgreywal@americanscitech.com

Locations
United States, New Jersey
MedCenter Not yet recruiting
East Brunswick, New Jersey, United States, 08816
Contact: Sarath Babu, MD.    908-941-5480    rgreywal@americanscitech.com   
Contact: Ratna Grewal, MD.    908-941-5480    rgreywal@americanscitech.com   
Sub-Investigator: Gregory Shypula, MD.         
Sponsors and Collaborators
American Scitech International
ImClone LLC
Bristol-Myers Squibb
Investigators
Study Chair: Ratna Grewal, MD. American Scitech International- eCRO
Principal Investigator: Sarath Babu, MD. MedCenter Primary and Internal Medicine
  More Information

No publications provided

Responsible Party: Ratna Grewal MD., American Scitech International
ClinicalTrials.gov Identifier: NCT00816959     History of Changes
Other Study ID Numbers: ASI-HDIII 0109
Study First Received: January 5, 2009
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by American Scitech International:
Lymphocytic Predominant Hodgkin's Lymphoma
Late, widespread and recurrent LPHD

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 23, 2014