AzTrials
AzTrials

Hodgkin's LymphomaPhase 2HIJAKNCT01877005

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

A Phase 2 study testing Ruxolitinib in people with Hodgkin's Lymphoma, run by The Lymphoma Academic Research Organisation at 10 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hodgkin's Lymphoma
What is being tested?
Ruxolitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
10 sitesin 2 countries
Study dates
4 Jul 2013to 12 Jun 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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]
Show all 14Show fewer
  • 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)

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

France8 sites

  • Chu Cote de Nacre

    Caen, 14000

  • Hopital Henri Mondor

    Créteil, 94010

  • Chu Dijon

    Dijon, 21000

  • Chru de Lille

    Lille, 59037

  • Centre Leon Berard

    Lyon, 69373

  • Centre Hospitalier Lyon Sud

    Lyon, 69495

  • CHU de Nantes, Hotel Dieu

    Nantes, 44093

  • Centre Henri Becquerel

    Rouen, 76038

Other trials in France

Belgium2 sites

  • UCL Louvain St Luc

    Brussels, 10200

  • Université Catholique de Louvain Mont Godinne

    Yvoir, 5530

Other trials in Belgium

About this study

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.

Being tested
Ruxolitinib
Keywords
Multicenter, single arm and opened label phase II study
Medical subject headings
Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01877005
Study groupRoleWhat they receive
RuxolitinibExperimentalInduction 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.
Receives: Drug: Ruxolitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

Secondary outcomes (9)

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 2 months, 4 months and 6 months

  3. 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.

    Measured: 6 months

  4. Safety endpoints

    Description of all adverse events, vital signs measurements, clinical laboratory measurements and concomitant medications.

    Measured: 30 months

  5. 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.

    Measured: Up to 30 months

  6. 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.

    Measured: Up to 4.5 years

  7. 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.

    Measured: Up to 4.5 years

  8. 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.

    Measured: Up to 4.5 years

  9. 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

    Measured: Up to 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2013 (estimated)
  2. Study start4 Jul 2013
  3. Primary completionJun 2015
  4. Study completion12 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01877005
Sponsor's protocol ID
HIJAK
Acronym
HIJAK
Status last verified
Aug 2018
First submitted
11 Jun 2013
Last updated
22 Aug 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Van Den Neste E, Andre 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.

    PubMed 29351986

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ruxolitinib in people with Hodgkin's Lymphoma, run by The Lymphoma Academic Research Organisation at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response Rate (ORR) according to Cheson 2007 (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01877005, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in