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Trial record 84 of 1216 for:    "Hodgkin lymphoma"

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

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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

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.

Condition or disease Intervention/treatment Phase
Hodgkin's Lymphoma Drug: Ruxolitinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Oral JAK1/JAK2 Inhibitor INC424 in Adult Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma
Actual Study Start Date : July 4, 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 12, 2018


Arm Intervention/treatment
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.

Drug: Ruxolitinib
Other Name: JAKAVI




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. Safety endpoints [ Time Frame: 30 months ]
    Description of all adverse events, vital signs measurements, clinical laboratory measurements and concomitant medications.

  5. 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.

  6. 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.


  7. 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.


  8. 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.


  9. 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


Other Outcome Measures:
  1. Anatomopahtological study [ Time Frame: baseline ]
    • FISH: JAK2 copies and rearrangements
    • Immunohistochemistry: JAK2 overexpression



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01877005


Locations
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Belgium
UCL Louvain St Luc
Brussels, Belgium, 10200
Université Catholique de Louvain Mont Godinne
Yvoir, Belgium, 5530
France
Chu Cote de Nacre
Caen, France, 14000
Hopital Henri Mondor
Creteil, France, 94010
Chu Dijon
Dijon, France, 21000
Chru de Lille
Lille, France, 59037
Centre Leon Berard
Lyon, France, 69373
Centre Hospitalier Lyon Sud
Lyon, France, 69495
CHU de Nantes, Hotel Dieu
Nantes, France, 44093
Centre Henri Becquerel
Rouen, France, 76038
Sponsors and Collaborators
The Lymphoma Academic Research Organisation
Novartis
Investigators
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Principal Investigator: Eric Van Den Neste, MD Lymphoma Study Association
Principal Investigator: Franck Morschhauser, MD Lymphoma Study Association

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The Lymphoma Academic Research Organisation
ClinicalTrials.gov Identifier: NCT01877005     History of Changes
Other Study ID Numbers: HIJAK
First Posted: June 13, 2013    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018

Keywords provided by The Lymphoma Academic Research Organisation:
Multicenter, single arm and opened label phase II study

Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases