Clinical trial · Interventional
Crizotinib Combined With Etoposide Capsule Followed by Auto-HSCT for Relapsed and Refractory ALK+ ALCL
Single-arm, Multi-center Clinical Study of Crizotinib Combined With Etoposide Capsule Followed by Auto-HSCT for Relapsed and Refractory Anaplastic Lymphoma Kinase (ALK)-Positive Anaplastic Large Cell Lymphoma (ALCL)
NCT03707847CI-TRIAL-00035292unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ALK-Positive Anaplastic Large Cell Lymphoma | Anaplastic Large Cell Lymphoma, ALK-Positive | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Auto-HSCT | Procedure | — | UNRESOLVED |
| Crizotinib | Drug | Crizotinib | ALIAS |
| Etoposide Capsule | Drug | Etoposide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Crizotinib + etoposide capsule+Auto-HSCT
- description
- Crizotinib and etoposide capsule followed by autologous hematopoietic stem cell transplantation. Crizotinib: 250mg, bis in die (BID), PO. Etoposide capsule:50mg, quaque die (QD), PO, d1-10,21days for one cycle. Patients will receive the treatment of crizotinib and etoposide capsule, and those who have achieved CR(complete response)or VGPR(very good partial response)will undergo the Auto-HSCT.
- interventionNames
- Drug: Crizotinib
- Drug: Etoposide Capsule
- Procedure: Auto-HSCT
Primary outcomes (2)
- measure
- ORR
- timeFrame
- up to 24 months
- description
- Objective Responder Rate
- measure
- PFS
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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 pregnancy or lactation period; * uncontrolled internal medicine disease(including uncontrolled diabetes,severe incompetence cardiac,lung,liver and pancreas); * with severe infection; * with primary or secondary central nervous system tumor invasion; * with immunotherapy or radiotherapy contraindication; * ever suffered with malignant tumor; * having peripheral nervous system disorder or dysphrenia; * with no legal capacity,medical or ethical reasons affecting research proceeding; * participating other clinical trials simultaneously; * adopting other anti-tumor medicine excluding this research; * Patients with immunodeficiency, such as primary immunodeficiency syndrome or organ transplant recipients * Human immunodeficiency virus (HIV)-positive patients * the researchers considering it inappropriate to participate in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.