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 range

14 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

ORR

Timeframe: up to 24 months

PFS

Timeframe: up to 24 months

Trial details

NCT IDNCT03707847

SponsorMingzhi Zhang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-01

Contact for this trial

Mingzhi zhang, Pro,Dr

13838565629 Mingzhi_zhang@126.com

View on ClinicalTrials.gov More ALK-Positive Anaplastic Large Cell Lymphoma trials

Who can participate

Age range

14 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.