Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin's Lymphoma | Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABVD | Drug | — | UNRESOLVED |
| R-mabHDI and ABVD | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I: R-mabHDI and ABVD
- interventionNames
- Drug: R-mabHDI and ABVD
- type
- ACTIVE_COMPARATOR
- label
- Arm II: ABVD
- interventionNames
- Drug: ABVD
Primary outcomes (1)
- measure
- The primary efficacy criterion is the response rates (RR) by Kaplan-Meier at 3,6,12, and 18 months.
- timeFrame
- 18 months
Secondary outcomes (1)
- measure
- Additional secondary endpoint criterion is the progress free survival (PFS) by Kaplan-Meier at 18 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available