Pilot Study of Crizotinib in Relapsed ALK+ Lymphomas

NCT02419287 | Completed Phase 2

• 1 other identifier: CRU1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the response and the duration of it in patients affected by ALK+ lymphoma that are resistant or refractory to standard cytotoxic treatment that will be treated with crizotinib.

Conditions

Anaplastic Large Cell Lymphoma, ALK-Positive

Keywords

ALK; crizotinib

Outcome Measures

Primary Outcomes (2)

• objective response rates (ORR) in subjects with ALK+ lymphomas resistant or refractory to standard cytotoxic treatment, according to RECIST 1.1 criteria.

  the entire duration of the study (5 years)

• Duration ORR

  the entire duration of the study (5 years)

Secondary Outcomes (4)

• Progression free survival (PFS) in ALK+ lymphoma patients treated with crizotinib, that are resistant or refractory to standard cytotoxic treatment.

  the entire duration of the study (5 years)

• Number of patients with adverse events after crizotinib treatment

  the entire duration of the study (5 years)

• Quality of Life (QoL) in this population of patients using the the EORTC - C30 Quality of Life questionnaire

  the entire duration of the study (5 years)

• Overall survival (OS) in ALK+ lymphoma patients treated with crizotinib

  the entire duration of the study (5 years)

Study Arms (1)

crizotinib

EXPERIMENTAL

250mg BID

Drug: crizotinib

Interventions

crizotinib DRUG

crizotinib

Eligibility Criteria

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

You may qualify if:

• Signed and dated Informed Consent approved by Local Ethical Committee before any protocol-specific screening procedures.
• ALK+ Non-Hodgkin lymphoma diagnosed by IHC or FISH.
• Refractory disease or relapse after at least one prior chemotherapy regimen (typically a minimum of 6 cycles of CHOP); presence of measurable disease by physical examination, CT or CT-PET scan.
• Any prior chemotherapy or major surgeries must have been completed at least 14 days prior to initiation of study medication. This could not be respected if there is clear evidence of disease progression, manifested as growing pain attributable to the tumour, fever, growing tumour lesions, increasing LDH values.
• Able to take oral therapy.
• Female or male, 18 years of age or older.
• ECOG performance status 0-3.
• Adequate organ function as defined by the following criteria:
• Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN) or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy
• Total serum bilirubin 1.5 x ULN (except patients with documented Gilbert's syndrome
• Creatinine ≤ 1.5 x ULN.
• Adequate bone marrow function:
• Absolute neutrophil count (ANC) ≥ 1000/µL
• Platelets ≥ 50.000/µL
• Hemoglobin ≥ 9.0 g/dL The hematological values will not be considered in case of bone marrow involvement.

You may not qualify if:

• Current treatment on another therapeutic clinical trial.
• Prior therapy specifically directed against ALK.
• Major surgery within 14 days prior first dose of crizotinib.
• History of uncontrolled cardiac disease including: myocardial infarct, uncontrolled angina or hypertension, clinically significant ventricular arrhythmia, unexplained syncope.
• Pregnancy or breastfeeding.
• Use of drugs or foods that are known potent CYP3A4 inhibitors, including but not limited to amprenavir, atazanavir, clarithromycin, delavirdine, diltiazem, erythromycin, indinavir, itraconazole, ketoconazole, miconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, verapamil, voriconazole, and grapefruit or grapefruit juice.
• Use of drugs that are known potent CYP3A4 inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, tipranavir, ritonavir, and St. John's wort.
• Use of drugs that are CYP3A4 substrates with narrow therapeutic indices, including but not limited aripiprazole, ergotamine, halofantrine, pimozide, triazolam, astemizole\*, cisapride\*, and terfenadine\* (\* withdrawn from U.S. market).
• Prior malignancy other than basal cell carcinoma.
• Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration.

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

ASST-Monza

Monza, Italy/MB, 20900, Italy

Location

Related Publications (1)

• Rindone G, Aroldi A, Bossi E, Verga L, Zambrotta G, Tarantino S, Piazza R, Mussolin L, Chiarle R, Gambacorti-Passerini C. A monocentric analysis of the long-term safety and efficacy of crizotinib in relapsed/refractory ALK+ lymphomas. Blood Adv. 2023 Feb 14;7(3):314-316. doi: 10.1182/bloodadvances.2022007538. No abstract available.

  PMID: 35914224 RESULT

MeSH Terms

Conditions

Lymphoma, Large-Cell, Anaplastic

Interventions

Crizotinib

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopyridines; Pyridines

Study Officials

• Carlo Gambacorti Passerini, MD

  University of Milano Bicocca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2015
• First Posted: April 17, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 6, 2023

Record last verified: 2023-03

Locations

IT (1)