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

Phase 2
18 Years
Not Enrolling
Hodgkin's Lymphoma

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Trial Information

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

Inclusion 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response Rate (ORR) according to cheson 2007

Outcome Description:

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.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Eric Van Den Neste, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lymphoma Study Association


Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:




Start Date:

August 2013

Completion Date:

December 2017

Related Keywords:

  • Hodgkin's Lymphoma
  • Multicenter, single arm and opened label phase II study
  • Hodgkin Disease
  • Lymphoma