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

The Lymphoma Academic Research Organisation

Status and phase: Completed; Phase 2

Conditions: Hodgkin's Lymphoma

Treatments: Drug: Ruxolitinib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01877005

HIJAK

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Ruxolitinib

Experimental group

Description:

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.

Treatment:

Drug: Ruxolitinib