Lymphoma, Extranodal NK-T-Cell Clinical Trial
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 Lymphoma, Nasal Type
This study is to explore the efficacy and safety of GLIDE regiment in patients with aggressive NK/T cell lymphoma.
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.
Response and Toxicity Evaluation Baseline evaluations were finished 10 days before
enrollment, including history, physical examination, complete blood count, serum liver and
kidney function, serum lactate dehydrogenase level, marrow smear and biopsy, enhanced
computer tomography of neck, thorax, abdomen and pelvis and endoscopic investigation of
gastrointestinal tract if such sites involvement were indicated. Response was regularly
evaluated after every two cycles of GLIDE chemotherapy using the revised response criteria
for malignant lymphoma. Therefore, in this trial, complete response (CR) was defined as the
complete disappearance of all objective signs of disease, including enlarged lymph nodes or
hepatomegaly and splenomegaly at the restaging. Partial response (PR) was defined as at least
a 50% reduction of tumor volume without the occurrence of new lesions at the restaging.
Progressive disease was defined as a greater than 25% increase in the sum of tumor lesions or
the emergence of one or more new lesion(s) or clinical symptoms that indicate disease
progression. No response was defined as any response that did not fall into the other defined
categories. The toxicity of treatment was graded using Common Terminology Criteria for
Adverse Events (CTCAE) version 3.0.
Statistical Analysis Outcome analysis was performed using life table methods and associated
statistics. The primary endpoints were ORR and CR rate after 4 cycles of GLIDE chemotherapy.
The second end points were 3-year OS and toxicity. Survival estimates were calculated using
the Kaplan-Meier method. All analysis were performed using Prism, version 5.0, software
(Graphpad Software, Inc.)
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