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

This study is not yet open for participant recruitment.
Verified July 2011 by American Scitech International
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
History of Changes

January 5, 2009
July 19, 2011
July 2011
April 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00816959 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Study Evaluating the Effect of R-mabHDI in Lymphocytic Predominant Hodgkin's Lymphoma
Phase III Randomized, Multi-center Study to Evaluate the Effect of R-mabHDI in Patients With Lymphocytic Predominant Hodgkin's Lymphoma

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.

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 .
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hodgkin's Lymphoma
  • 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
  • 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
  • Active Comparator: Arm I: R-mabHDI and ABVD
    Intervention: Drug: R-mabHDI and ABVD
  • Active Comparator: Arm II: ABVD
    Intervention: Drug: ABVD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
1200
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
16 Years to 65 Years
No
Contact: Ratna Grewal, MD 908-941-5480 rgreywal@americanscitech.com
United States
 
NCT00816959
ASI-HDIII 0109
No
Ratna Grewal MD., American Scitech International
American Scitech International
  • ImClone LLC
  • Bristol-Myers Squibb
Study Chair: Ratna Grewal, MD. American Scitech International- eCRO
Principal Investigator: Sarath Babu, MD. MedCenter Primary and Internal Medicine
American Scitech International
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP