HD18 for Advanced Stages in Hodgkins Lymphoma

University of Cologne

Status and phase: Completed; Phase 3

Conditions: Hodgkins Lymphoma

Treatments: Drug: BEACOPP escalated; Drug: Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT00515554

HD18

Details and patient eligibility

About

This study is designed to test:

1. in patients with negative positron-emission tomography (PET) after 2 cycles of BEACOPPesc chemotherapy: whether the number of cycles can be reduced without compromising progression free survival (PFS) (2 further cycles vs. 6 further cycles)
2. for patients with positive PET after 2 cycles: whether intensifying BEACOPPesc chemotherapy by adding Rituximab improves PFS.

Enrollment: 1,500 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hodgkin Lymphoma (histologically proven)

• CS (PS) IIB with one or both of the risk factors:

  • bulky mediastinal mass (> 1/3 of maximum transverse thorax diameter)
  • extranodal involvement

• CS (PS) III, IV

• Written informed consent

Exclusion criteria

• Leucocytes < 3000/µl
• Platelets < 100000/µl
• Hodgkin´s lymphoma as "composite lymphoma"
• Activity index (WHO) < grade 2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,500 participants in 4 patient groups

A

Active Comparator group

Description:

8 cycles BEACOPPesc

Treatment:

Drug: BEACOPP escalated

B

Experimental group

Description:

8 cycles BEACOPPesc plus rituximab

Treatment:

Drug: Rituximab

Drug: BEACOPP escalated

C

Active Comparator group

Description:

8 cycles BEACOPPesc

Treatment:

Drug: BEACOPP escalated

D

Experimental group

Description:

4 cycles BEACOPPesc

Treatment:

Drug: BEACOPP escalated