Clinical Trial: GLIDE Regiment Followed by ASCT for Aggressive NK/T Cell Lymphoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Study of Gemcitabine, L- Asparaginase, Ifosfamide, Dexamethasone and Etoposide Chemotherapy Followed by ASCT for Newly Diagnosed Stage IV, Relapsed or Refractory Extranodal Natural Killer/T-cell Lym

Brief Summary: This study is to explore the efficacy and safety of GLIDE regiment in patients with aggressive NK/T cell lymphoma.

Detailed Summary:

Treatment

The dose and schedule of GLIDE chemotherapy was administered as following: gemcitabine 800 mg/m2, day 1,5; peg-asparaginase 2000 u/m2, day 4,11; ifosfamide 1000 mg/m2, day 1-3; etoposide 100mg/m2, day 1-3; dexamethasone 20mg day 1-4 . Gemcitabine on day 5 should be skipped if any grade 3 or above hematologic toxicities developed. Peg-asparaginase should be discontinued if patients developed any asparaginase related allergic reaction. Granulocyte colony stimulating factor was started on day 4 till full recovery of absolute neutrophils count (ANC, defined as above 2×109/L). The interval between 2 cycles of chemotherapy is 4 weeks and before initiation of a new cycle of chemotherapy, severity of all non-hematologic adverse events must be less than grade 2, ANC above 2×109/L and platelets count above 80×109/L. If adverse events failed to recover, the following cycle of chemotherapy should be postponed for one week. If there was no recovery 4 weeks before the day of the scheduled following cycle, the protocol treatment was terminated. Totally, 6 cycles of GLIDE chemotherapy was planned for protocol treatment. Response of lymphoma should be evaluated every 2 cycles.

Hematopoietic stem cells of patients with best response better than partial response (PR), including PR and complete response (CR) after up to 6 cycles of GLIDE, were collected. receive When complete response is attained, peripheral hematopoietic stem cells should be collected. Fitted patients will treated with chidamide, cladribine, gemcitabine and busulfan ( ChiCGB) conditioning followed by autologous stem cell transplantation (ASCT). Patients who are unable to receive ASCT, continued with GLIDE for up to 6 cycles. Patients who are unable to attain PR after 6 cycles of GLIDE, drop off this trial.

2-year progression free survival