Clinical Trials Logo
  1. Home
  2. Classic Hodgkin Lymphoma
  3. NCT00654732

Combination Chemotherapy With or Without Rituximab in Treating Participants With Stage III-IV Classic Hodgkin Lymphoma

Classic Hodgkin Lymphoma Clinical Trial

Official title:
A Randomized Phase II Study of Rituximab With ABVD Versus Standard ABVD for Patients With Advanced-Stage Classical Hodgkin Lymphoma With Poor Risk Features (IPS Score > 2)

Clinical Trial Summary

This phase II trial studies how well combination chemotherapy with or without rituximab works in treating participants with stage III-IV classic Hodgkin lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving rituximab with combination chemotherapy may work better in treating participants with classic Hodgkin lymphoma.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To evaluate the event free survival (EFS) following therapy with rituximab plus adriamycin (doxorubicin hydrochloride), bleomycin, vinblastine, and dacarbazine (ABVD) or standard ABVD in patients with newly diagnosed classical Hodgkin lymphoma who have poor prognosis defined as International prognostic score (IPS) of > 2.

SECONDARY OBJECTIVES:

I. To compare the effect of the two treatment arms on positron emission tomography (PET) scan results after 2 cycles of therapy.

II. To compare the effect of the two treatment arms on the level of circulating malignant Hodgkin stem cells.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM A: Participants receive rituximab intravenously (IV) over 7 hours on days 1, 8, 15, and 22 of course 1 and on days 1 and 8 of course 2. Participants also receive doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine IV over 1 hour on days 1 and 15. Treatment with ABVD repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

ARM B: Participants receive doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine as in Arm A.

After completion of study treatment, participants are followed up every 3 months for the first year, every 4 months for the second year, every 6 months for years 3-5, and then annually thereafter. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00654732
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Completed
Phase Phase 2
Start date March 19, 2008
Completion date September 5, 2018
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03233347 - Doxorubicin, Vinblastine, Dacarbazine, Brentuximab Vedotin, and Nivolumab in Treating Patients With Stage I-II Hodgkin Lymphoma Phase 2
Active, not recruiting NCT03712202 - Brentuximab Vedotin and Nivolumab in Treating Patients With Early Stage Classic Hodgkin Lymphoma Phase 2
Recruiting NCT05833984 - Safety and Efficacy of IMM01 Plus Tislelizumab in Patients With Advanced Solid Tumors and Lymphomas Phase 1/Phase 2
Active, not recruiting NCT02758717 - Nivolumab and Brentuximab Vedotin in Treating Older Patients With Untreated Hodgkin Lymphoma Phase 2
Active, not recruiting NCT01771107 - Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With Stage II-IV HIV-Associated Hodgkin Lymphoma Phase 1/Phase 2
Active, not recruiting NCT02166463 - Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma Phase 3
Active, not recruiting NCT04788043 - Study of Magrolimab and Pembrolizumab in Relapsed or Refractory Classic Hodgkin Lymphoma Phase 2
Not yet recruiting NCT06465446 - A Study of IMM01 in Combiniation With Tiselizumab Versus Physician's Choice Chemotherapy in PD-(L)1-refractory Classical Hodgkin Lymphoma Phase 3
Recruiting NCT05955105 - A Study of ILB2109 and Toripalimab in Patients With Advanced Solid Malignancies Phase 1/Phase 2
Completed NCT06235047 - Liposomal Doxorubicin-containing Front-line Treatment in Elderly Patients With HL (HL-MVD)
Recruiting NCT06164275 - Pembrolizumab Followed by Chemotherapy for the Treatment of Patients With Classical Hodgkin Lymphoma Phase 2
Active, not recruiting NCT05179603 - A Study of SAR444245 With or Without Other Anticancer Therapies for the Treatment of Adults and Adolescents With Relapsed or Refractory B Cell Lymphoma (Master Protocol) [Pegathor Lymphoma 205] Phase 2
Active, not recruiting NCT03907488 - Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma Phase 3
Not yet recruiting NCT05949931 - Pianzumab Combined With AVD Regimen in the Treatment of Newly-diagnosed Advanced Classic Hodgkin Lymphoma Phase 2
Not yet recruiting NCT06377540 - MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma Phase 2
Active, not recruiting NCT03057795 - Nivolumab & Brentuximab Vedotin Consolidation After Autologous SCT in Patients With High-Risk Classical Hodgkin Lymphoma Phase 2