NCT02487316

Brief Summary

The purpose of this study is to determine the efficacy and safety of crizotinib combined with CHOP chemotherapy for patients with ALK(+) Systemic Anaplastic Large Cell Lymphoma.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 30, 2016

Status Verified

December 1, 2016

Enrollment Period

2.3 years

First QC Date

June 30, 2015

Last Update Submit

December 28, 2016

Conditions

Systemic Anaplastic Large-Cell Lymphoma

Keywords

Anaplastic Large Cell Lymphomaanaplastic lymphoma kinase rearrangementcrizotinibCHOP chemotherapy

Outcome Measures

Primary Outcomes (1)

  • complete remission rate

    2 years

Secondary Outcomes (5)

  • disease-free survival

    2 years

  • overall survival

    2 years

  • objective response rate

    2 years

  • incidence of >/Grade 3 non-hematology toxicity adverse events

    2 years

  • QOL assessment

    2 years

Study Arms (1)

crizotinib combined with chemotherapy

EXPERIMENTAL

crizotinib 250mg, bid from day 1 to 18 weeks. cyclophosphamide, 750mg/m2,d1, vincristine, 1.4mg/m2, maximal dose is 2mg d1, doxorubicin, 50mg/m2d1, prednison, 100 mg d1-5) every 3 weeks for up to six cycles.

Drug: crizotinib

Interventions

crizotinibDRUG

crizotinib 250mg, oral, bid from day 1 to 18 weeks. cyclophosphamide, 750mg/m2,d1, vincristine, 1.4mg/m2, maximal dose is 2mg d1, doxorubicin, 50mg/m2d1, prednison, 100 mg d1-5) every 3 weeks for up to six cycles.

Also known as: CHOP chemotherapy
crizotinib combined with chemotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary ALK(+) systemic anaplastic large cell lymphoma histologically confirmed by biopsy without therapy
  • ECOG 0-2
  • more than 1 measurable lesions with major axis \>1.5cm and minor axis\>1.0cm
  • estimated survival \>/3months
  • Age 18-65 years
  • Women of childbearing age should have a negative pregnancy test; men and women who need to agree to use effective contraception during the period of treatment and the following 1 years
  • Signature of informed consent

You may not qualify if:

  • Age \<\\ 18years
  • without ALK(+) systemic anaplastic large cell lymphoma histologically confirmed by biopsy
  • without measurable lesions
  • being treated by other drugs in other clinical trials
  • Pregnant or lactating women, who are not willing to take contraceptive measures during the study period, or are not willing to use effective contraceptive measures during the period of treatment and the following 1 years
  • Hepatic insufficiency: serum total bilirubin, ALT more than 2 times higher than normal
  • Renal insufficiency: more than 2 times higher than that of normal serum creatinine
  • Blood screening period: WBC \< 1 \* 109/L \* 109/L; platelet \< 25; Hb \< 60g/L
  • HIV test positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weiping Liu

Beijing, Beijing Municipality, 100142, China

Location

Related Publications (1)

  • Boi M, Zucca E, Inghirami G, Bertoni F. Advances in understanding the pathogenesis of systemic anaplastic large cell lymphomas. Br J Haematol. 2015 Mar;168(6):771-83. doi: 10.1111/bjh.13265. Epub 2015 Jan 6.

    PMID: 25559471RESULT

MeSH Terms

Conditions

Lymphoma, Large-Cell, Anaplastic

Interventions

CrizotinibR-CHOP protocol

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAminopyridinesPyridines

Study Officials

  • Jun Zhu, MD

    Peking University Cancer Hospital & Institute

    STUDY CHAIR
0

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
Department of Hematology Oncology, clinical oncology college, Director of department, Party Secretary

Study Record Dates

First Submitted

June 30, 2015

First Posted

July 1, 2015

Study Start

July 1, 2015

Primary Completion

November 1, 2017

Study Completion

December 1, 2017

Last Updated

December 30, 2016

Record last verified: 2016-12

Locations

CN(1)