Table 6 Randomized, phase III trial studies of rituximab combined chemotherapy regimens in relapsed/refractory DLBCL

R- DHAP-VIM-DHAP (A) vs. DHAP-VIM-DHAP (B)

Prior to BEAM/ASCT

Patient No.: 239

Age: 18 to 65 y;

Survival benefits of combining rituximab with HDC/ASCT:

2-year FFS: 50 (A) vs 24 % (B)

2-year PFS: 52 (A) vs 31 % (B)

Completed phase III

[191]

Trial-No: NCT00012051 (HOVON-44 study)

R-ICE (A) vs. R-DHAP (B)

After HDC/ASCT

Patient No.: 477

Age: 18 to 65 y;

No survival differences between R-ICE and R-DHAP Rituximab maintenance has no defined role in relapsed DLBCL after ASCT

Completed phase III

[193, 624]

Trial-No: NCT00137995 (CORAL study)

R-GDP vs. R-DHAP

As salvage chemotherapy prior to ASCT

Patient No.: 619

Age: 16 to 65 y

No survival differences between R-GDP and R-DHAP GDP is associated with less toxicity and hospitalization, and superior quality of life.

Completed phase III

[195]

Trial-No: NCT00078949

R-BEAM vs. Bexxar/BEAM prior to ASCT

Patient No.: 224

Age: 18 to 80 y

B-BEAM and R-BEAM regimens produced similar 2-year PFS and OS rates

Completed phase III

[194]

Trial-No: NCT00329030

Ofatumumab + DHAP vs. R-DHAP As salvage chemoimmunotherapy followed by ASCT

Patient No.: 445

Age: 18 to 65

NA

Completed phase III

Trial-No:NCT01014208 (ORCHARRD study)

R-DHAP +/− Bortezomib As induction therapy before HDC/BEAM/ASCT

Patient No.: 108 (estimated)

Age: 18 to 65 (estimated)

NA

Ongoing Phase III

Trial-No: NCT01805557 (FILVERAL12 study)

90-Yttrium Ibritumomab Tiuxetan (Zevalin) +/− R-BEAM

Patient No.: 158 (estimated)

Age: 18 to 70 (estimated)

NA

Ongoing Phase III

Trial-No: NCT02366663 (SPINOZA study)