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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-04

Study Completion Date

2018-06-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Hodgkin's Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Ruxolitinib

Intervention Type DRUG

Interventions

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Ruxolitinib

Intervention Type DRUG

Other Intervention Names

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JAKAVI

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No