Crizotinib Combined With Etoposide Capsule Followed by Auto-HSCT for Relapsed and Refractory ALK+ ALCL

NCT03707847 | Unknown Phase 4 FDA Drug

• 1 other identifier: hnslblzlzx20180821
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ALK-Positive Anaplastic Large Cell Lymphoma

Keywords

crizotinib; etoposide; autologous hematopoietic stem cell transplantation; ORR; OS; PFS; adverse events

Outcome Measures

Primary Outcomes (2)

• ORR

  Objective Responder Rate

  up to 24 months

• PFS

  Progression Free Survival

  up to 24 months

Secondary Outcomes (2)

• OS

  up to 24 months

• adverse events

  up to 24 months

Study Arms (1)

Crizotinib + etoposide capsule+Auto-HSCT

EXPERIMENTAL

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.

Drug: Crizotinib; Drug: Etoposide Capsule; Procedure: Auto-HSCT

Interventions

Crizotinib DRUG

250mg, BID, PO

Crizotinib + etoposide capsule+Auto-HSCT

Etoposide Capsule DRUG

50mg, QD, PO, d1-10，21days for one cycle

Crizotinib + etoposide capsule+Auto-HSCT

Auto-HSCT PROCEDURE

Auto-HSCT will be performed with patients who have achieved CR or VGPR.

Crizotinib + etoposide capsule+Auto-HSCT

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mingzhi Zhang: lead

Study Sites (1)

Oncology Department of The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

MeSH Terms

Interventions

Crizotinib; Etoposide

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopyridines; Pyridines; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Mingzhi zhang

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingzhi zhang, Pro,Dr

CONTACT

13838565629; Mingzhi_zhang@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: the director of oncology department of the first affiliated hospital

Study Record Dates

• First Submitted: September 23, 2018
• First Posted: October 16, 2018
• Study Start: October 1, 2018
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2021
• Last Updated: October 16, 2018

Record last verified: 2018-09

Locations

CN (1)