Crizotinib Combined With Etoposide Capsule Followed by Auto-HSCT for Relapsed and Refractory ALK+… (NCT03707847) | Clinical Trial Compass
UnknownPhase 4
Crizotinib Combined With Etoposide Capsule Followed by Auto-HSCT for Relapsed and Refractory ALK+ ALCL
China20 participantsStarted 2018-10-01
Plain-language summary
To observe the safety, tolerability and clinical effects of crizotinib combined with etoposide capsule followed by autologous hematopoietic stem cell transplantation (Auto-HSCT) for patients with relapsed and refractory ALK-positive Anaplastic Large Cell Lymphoma.
Who can participate
Age range14 Years – 65 Years
SexALL
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Criteria: Inclusion Criteria:
* age:14-65 years;Eastern Cooperative Oncology Group (ECOG)score≤3;expected survival≥3 months
* patients with ALK-positive Anaplastic Large Cell Lymphoma diagnosed by immuno-histochemistry (IHC) or fluorescence in situ hybridization (FISH);
* Refractory or relapse after at least 4 cycles of CHOP(cyclophosphamide, hydroxydaunomycin, Oncovin, and prednisone)regimen
* acceptable hematological indicators, no chemotherapy contraindications;
* total bilirubin ≤ 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 2.5 x upper age limit (ULN), if the abnormal laboratory parameters are considered to be caused by lymphoma, patients Eligible conditions should be adjusted to be incorporated into the group;
* At least one measurable lesion by CT or PET-CT(Positron Emission Tomography-Computed Tomography);
* exclude other major diseases, normal heart and lung function;
* Female patients of childbearing age are negative for pregnancy test;
* Cooperate with follow-up;
* There are no other related treatments including traditional Chinese medicine, immunotherapy, and biologic therapy (except for the treatment of anti-bone metastases and other symptoms);
* Signing informed consent \*: Pathological histology must be consulted by a pathologist at a provincial hospital.
Exclusion Criteria:
* rejecting providing blood preparation;
* allergic to drug in this study and with metabolic block;
* rejecting adopting reliable contraceptive method in p…