A Phase II Study of Oral JAK1/JAK2 Inhibitor INC424 in Adult Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma

Hodgkin's Lymphoma Clinical Trial

— HIJAK  

Official title:

A Phase II Study of Oral JAK1/JAK2 Inhibitor INC424 in Adult Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877005
• Other study ID #: HIJAK
• Status: Completed
• Phase: Phase 2
• Start date: July 4, 2013
• Est. completion date: June 12, 2018

Study information

• Verified date: August 2018
• Source: The Lymphoma Academic Research Organisation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase II study to assess the efficacy of 6 cycles of oral JAK1/2 inhibitor ruxolitinib in patients with advanced Hodgkin's lymphoma for whom no curative option is available.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 12, 2018
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion critera:

• Patients = 18 years with classical HL relapsing or refractory after at least 1 prior systemic therapy. Patients must have relapsed after high-dose therapy with ASCT, or have been deemed ineligible for high-dose therapy with ASCT

• ECOG performance status = 3

• Measurable nodal disease: 1 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan (MRI is allowed only if CT scan cannot be performed).

• Patient has the following laboratory values:

• Absolute neutrophil count (ANC) = 1.0 x 10^9/L [SI units 1.0 x 10^9/L]

• Platelet count = 75 x 10^9/L]

• Serum creatinine = 1.5 x upper limit of normal (ULN)

• Serum bilirubin = 1.5 x ULN (or = 3.0 x ULN, if patient has Gilbert syndrome)

• AST/SGOT and/or ALT/SGPT = 2.5 x ULN or = 5.0 x ULN if the transaminase elevation is due to liver disease involvement

• Signed written informed consent

• Life expectancy = 3 months

• Corrected QT interval = 450 mSec

• Men and women of childbearing potential must agree to use an adequate method of contraception during the study treatment and for at least 1 week after the last study drug administration

• The patient must be covered by a social security system (for inclusions in France)

Exclusion criteria:

• Previous treatment with ruxolitinib or another JAK inhibitor

• Contraindication to ruxolitinib

• Patient received chemotherapy or radiotherapy or any investigational drug within 14 days prior to starting study drug or whose side effects of such therapy have not resolved to = grade 1

• Patient treated with allogeneic hematopoietic stem cell transplant who is currently on, or has received immunosuppressive therapy within 90 days prior to start of screening and/or have = Grade 2 graft versus host disease (GvHD).

• Patient with prior history of another active primary malignancy = 2 years before study entry, with the exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix

• Any serious active disease or co-morbid medical condition that, according to the investigator's decision, will substantially increase the risk associated with the subject's participation in the study.

• Uncontrolled infectious disease, including active HBV infection defined by either detection of HBs Antigen or presence of anti HBc antibody without detectable anti HBs antibody.

• HIV, HCV or HTLV serology positivity and/or documented infection with active hepatitis B

• Prior history of CNS involvement with lymphoma

• Pregnant or lactating woman

• Adult patient unable to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness.

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Lymphoma
• Lymphoma

Intervention

Drug:
• Ruxolitinib

Locations

Country	Name	City	State
Belgium	UCL Louvain St Luc	Brussels
Belgium	Université Catholique de Louvain Mont Godinne	Yvoir
France	Chu Cote de Nacre	Caen
France	Hopital Henri Mondor	Creteil
France	Chu Dijon	Dijon
France	Chru de Lille	Lille
France	Centre Hospitalier Lyon Sud	Lyon
France	Centre Leon Berard	Lyon
France	CHU de Nantes, Hotel Dieu	Nantes
France	Centre Henri Becquerel	Rouen

Sponsors (2)

Lead Sponsor	Collaborator
The Lymphoma Academic Research Organisation	Novartis

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anatomopahtological study	FISH: JAK2 copies and rearrangements; Immunohistochemistry: JAK2 overexpression	baseline
Primary	Overall response Rate (ORR) according to Cheson 2007	Overall Response Rate according to the International Working Group criteria (Cheson 2007) is defined as patient with Complete response or Partial response.; Patient without response assessment (due to whatever reason) will be considered as non responder.	6 months
Secondary	Overall response rate (ORR) according to Cheson 1999	Overall Response Rate according to the International Working Group criteria (Cheson 1999) is defined as patient with Complete response, unconfirmed Complete response or Partial response.; Patient without response assessment (due to whatever reason) will be considered as non responder.	6 months
Secondary	Complete response rates (CR) according to Cheson 2007 and 1999	Assessment of response will be based on the International Workshop to Standardize Response criteria for lymphoma: Cheson, 1999 and 2007.; Patient without response assessment (due to whatever reason) will be considered as nonresponder.	2 months, 4 months and 6 months
Secondary	Best Response Rate (BRR) according to Cheson 1999 and 2007	Disease response evaluation at 2; 4 and 6 months will be used to determine the Best Response Rate, according to Cheson 1999 and 2007.; The Best Complete Response and Best Overall Response will be presented. Patient without response assessment (due to whatever reason) will be considered as nonresponder.	6 months
Secondary	Safety endpoints	Description of all adverse events, vital signs measurements, clinical laboratory measurements and concomitant medications.	30 months
Secondary	Time to response	Time to response will be defined as the time from inclusion into the study to the time of attainment of PR or CR according to Cheson 2007 criteria.	Up to 30 months
Secondary	Duration of response	Duration of response will be measured from the time of attainment of CR or PR according to Cheson 2007 cirteria to the date of first documented disease progression, relapse or death from any cause.; Patients alive and free of progression will be censored at their last follow-up date.	Up to 4.5 years
Secondary	Progression Free Survival (PFS)	PFS is defined at the time from inclusion into the study to the first observation of documented disease progression/relapse according to Cheson 2007 criteria or death due to any cause.; If a subject has not progressed or died, PFS will be censored at the time of last visit.	Up to 4.5 years
Secondary	Overall Survival (OS)	OS will be measured from the date of inclusion to the date of death from any cause.; Patients who did not died will be censored at the time of last visit.	Up to 4.5 years
Secondary	Evaluation of systemic symptoms	Evaluation of efficacy of ruxolitinib on systemic symptoms such as fever, sweating, fatigue and itching will be done via systemic symptoms Questionnaire designed for this purpose and completed at Baseline and then at Day1 of each visit during Induction and Maintenance period of the study	Up to 30 months

External Links

•   LYSA (the Lymphoma Study Association)