Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01877005
Recruitment Status : Completed
First Posted : June 13, 2013
Last Update Posted : August 22, 2018
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
The Lymphoma Academic Research Organisation

Tracking Information
First Submitted Date  ICMJE June 11, 2013
First Posted Date  ICMJE June 13, 2013
Last Update Posted Date August 22, 2018
Actual Study Start Date  ICMJE July 4, 2013
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2014)
Overall response Rate (ORR) according to Cheson 2007 [ Time Frame: 6 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2013)
Overall response Rate (ORR) according to Cheson 2007 [ Time Frame: 6 months ]
Overall Response Rate according to the International Working Group critera (Cheson 2007) is defined as patient with Complete response or Partial response. Patient without response assessment (due to whatever reason) will be considered as nonresponder.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2014)
  • Overall response rate (ORR) according to Cheson 1999 [ Time Frame: 6 months ]
    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.
  • Complete response rates (CR) according to Cheson 2007 and 1999 [ Time Frame: 2 months, 4 months and 6 months ]
    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.
  • Best Response Rate (BRR) according to Cheson 1999 and 2007 [ Time Frame: 6 months ]
    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.
  • Safety endpoints [ Time Frame: 30 months ]
    Description of all adverse events, vital signs measurements, clinical laboratory measurements and concomitant medications.
  • Time to response [ Time Frame: Up to 30 months ]
    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.
  • Duration of response [ Time Frame: Up to 4.5 years ]
    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.
  • Progression Free Survival (PFS) [ Time Frame: Up to 4.5 years ]
    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.
  • Overall Survival (OS) [ Time Frame: Up to 4.5 years ]
    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.
  • Evaluation of systemic symptoms [ Time Frame: Up to 30 months ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2013)
  • Overall response rate (ORR) according to Cheson 1999 [ Time Frame: 6 months ]
    Overall Response Rate according to the International Working Group critera (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 nonresponder.
  • Complete response rates (CR) according to Cheson 2007 and 1999 [ Time Frame: 2 months, 4 months and 6 months ]
    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.
  • Best Response Rate (BRR) according to Cheson 1999 and 2007 [ Time Frame: 6 months ]
    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.
  • Safety endpoints [ Time Frame: 30 months ]
    Description of all adverse events, vital signs measurements, clinical laboratory measurements and concomitant medications.
  • Time to response [ Time Frame: Up to 30 months ]
    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.
  • Duration of response [ Time Frame: Up to 4.5 years ]
    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.
  • Progression Free Survival (PFS) [ Time Frame: Up to 4.5 years ]
    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.
  • Overall Survival (OS) [ Time Frame: Up to 4.5 years ]
    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.
  • Evaluation of systemic symptoms [ Time Frame: Up to 30 months ]
    Evaluation of efficacy of ruxolitinib on systemic symptoms such as fever, sweating, fatigue and itching will be described
Current Other Pre-specified Outcome Measures
 (submitted: August 31, 2015)
Anatomopahtological study [ Time Frame: baseline ]
  • FISH: JAK2 copies and rearrangements
  • Immunohistochemistry: JAK2 overexpression
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Study of Oral JAK1/JAK2 Inhibitor INC424 in Adult Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma
Official Title  ICMJE A Phase II Study of Oral JAK1/JAK2 Inhibitor INC424 in Adult Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hodgkin's Lymphoma
Intervention  ICMJE Drug: Ruxolitinib
Other Name: JAKAVI
Study Arms  ICMJE Experimental: Ruxolitinib

Induction period: Ruxolitinib will be given twice daily during 6 cycles of 28 days.

Maintenance period: patients who achieve at least a stable disease (according Cheson 2007) at the end of cycle 6 and for whose a clinical benefit is observed according to the Investigator's opinion will be eligible for maintenance treatment by ruxolitinib twice daily every day of 28-day cycles.

Intervention: Drug: Ruxolitinib
Publications * Van Den Neste E, André M, Gastinne T, Stamatoullas A, Haioun C, Belhabri A, Reman O, Casasnovas O, Ghesquieres H, Verhoef G, Claessen MJ, Poirel HA, Copin MC, Dubois R, Vandenberghe P, Stoian IA, Cottereau AS, Bailly S, Knoops L, Morschhauser F. A phase II study of the oral JAK1/JAK2 inhibitor ruxolitinib in advanced relapsed/refractory Hodgkin lymphoma. Haematologica. 2018 May;103(5):840-848. doi: 10.3324/haematol.2017.180554. Epub 2018 Jan 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2013)
33
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 12, 2018
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01877005
Other Study ID Numbers  ICMJE HIJAK
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Lymphoma Academic Research Organisation
Study Sponsor  ICMJE The Lymphoma Academic Research Organisation
Collaborators  ICMJE Novartis
Investigators  ICMJE
Principal Investigator: Eric Van Den Neste, MD Lymphoma Study Association
Principal Investigator: Franck Morschhauser, MD Lymphoma Study Association
PRS Account The Lymphoma Academic Research Organisation
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP