Study Evaluating the Effect of Rituximab in Lymphocytic Predominant Hodgkin's Lymphoma - Full Text View

Sponsors and Collaborators:	American Scitech International ImClone Systems Bristol-Myers Squibb
Information provided by:	American Scitech International
ClinicalTrials.gov Identifier:	NCT00816959

Purpose

Objective:

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

The hypothesis is that the combination of Rituximab 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 Rituximab.

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

Condition	Intervention	Phase
Hodgkin's Lymphoma	Drug: Rituximab and ABVD Drug: ABVD (adriamycin (doxorubicin), bleomycin, vinblastine and dacarbazine)	Phase III

MedlinePlus related topics: Hodgkin's Disease Lymphoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Dacarbazine Rituximab Vinblastine Vinblastine sulfate Bleomycin Bleomycin sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase III Randomized, Multi-Center Study to Evaluate the Effect of Rituximab in Patients With Lymphocytic Predominant Hodgkin's Lymphoma

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 2009
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Rituximab and ABVD: Active Comparator	Drug: Rituximab and ABVD The subjects will receive Rituximab intravenously, separately for about 7 hours on days 1,8,15 and 22 (once a week) of every cycle. Each cycle is 4 weeks. Rituximab 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.
Arm II: ABVD: Active Comparator	Drug: ABVD (adriamycin (doxorubicin), bleomycin, vinblastine and dacarbazine) 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.

Arms

Assigned Interventions

Arm I: Rituximab and ABVD: Active Comparator

Drug: Rituximab and ABVD

The subjects will receive Rituximab intravenously, separately for about 7 hours on days 1,8,15 and 22 (once a week) of every cycle. Each cycle is 4 weeks. Rituximab 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.

Arm II: ABVD: Active Comparator

Drug: ABVD (adriamycin (doxorubicin), bleomycin, vinblastine and dacarbazine)

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.

Detailed Description:

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

The hypothesis is that the combination of Rituximab 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 Rituximab.

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 Rituximab intravenously, separately for about 7 hours on days 1,8,15 and 22 (once a week) of every cycle. Each cycle is 4 weeks. Rituximab 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 Rituximab.

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

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

Contacts

Contact: Ratna Grewal, MD

732-981-8686

rgreywal@americanscitech.com

Locations

United States, New Jersey
MedCenter
East Brunswick, New Jersey, United States, 08816

Sponsors and Collaborators

American Scitech International

ImClone Systems

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

Responsible Party:	American Scitech International ( Ratna Grewal MD. )
Study ID Numbers:	ASI-HDIII 9877
Study First Received:	January 5, 2009
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00816959
Health Authority:	United States: Institutional Review Board

Keywords provided by American Scitech International:

Lymphocytic Predominant Hodgkin's Lymphoma
Late, widespread and recurrent LPHD

Study placed in the following topic categories:

Immunoproliferative Disorders
Hodgkin's disease
Dacarbazine
Rituximab
Hodgkin lymphoma, adult
Vinblastine
Bleomycin

Recurrence
Doxorubicin
Lymphatic Diseases
Lymphoproliferative Disorders
Lymphoma
Hodgkin Disease

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Antibiotics, Antineoplastic

Pharmacologic Actions
Neoplasms
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 13, 2009