Pilot Study of Ruxolitinib in Relapsed or Refractory Hodgkin Lymphoma and Primary Mediastinal Large B-cell Lymphoma

NCT01965119 | Completed Phase 2 DMC

• 1 other identifier: SMC 2013-06-039
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is that ruxolitinib may be a possible treatment option for relapsed or refractory patients with Hodgkin and primary mediastinal large B-cell lymphoma.

Conditions

Relapsed or Refractory Hodgkin Lymphoma; Primary Mediastinal Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• To assess the efficacy of disease control including complete response (CR), partial response (PR) and stable disease (SD)

  From date of enrollment until the date first documented disease progression or unacceptable toxicity, whichever came first, assessed up to 48months

Secondary Outcomes (2)

• Toxicity profile

  from the date of informed consent signature to 30days after last drug administration

• Overal Survival

  from the date of first drug administration until the date of death, assessed up to 48months

Study Arms (1)

Ruxolitinib

EXPERIMENTAL

20 mg orally twice a day for 4 weeks (One cycle) Treatment continued until documented disease progression or unacceptable toxicity.

Drug: Ruxolitinib

Interventions

Ruxolitinib DRUG

20 mg orally twice a day for 4 weeks (One cycle) Treatment continued until documented disease progression or unacceptable toxicity.

Also known as: jakavi

Ruxolitinib

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven Hodgkin lymphoma or primary mediastinal large B-cell lymphoma
• Patient should belong to any one of following clinical situations A.Patient who are not able to get autologous stem cell transplantation after relapsing the salvage chemotherapy B. Relapsed after autologous stem cell transplantation C. Refractory to salvage chemotherapy or autologous stem cell transplantation
• Adequate organ function as defined by the following criteria:
• A. Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase (SGOT)) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) ≤2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy B. Total serum bilirubin ≤1.5 x ULN C. Absolute neutrophil count (ANC) ≥ 1500/µL D. Platelets ≥ 100,000/µL E. Hemoglobin ≥ 9.0 g/dL (may be transfused or erythropoietin treated) F. Serum calcium ≤ 12.0 mg/dL G. Serum creatinine ≤ 1.5 x ULN
• At least one measurable lesion
• ECOG PS 0-2
• Informed consent
• Age from 19 to 80

You may not qualify if:

• Previously received allogeneic stem cell transplantation
• History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease or secondary CNS involvement on CT or MRI scan.
• Currently uncontrolled active infection
• Previous history of recurrent herpes zoster or recurrent tuberculosis
• Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2.
• Pregnant or lactating females or patients who ar not willing to use an adequate method of birth control for the duration of the study

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (7)

Busan University Hospital

Busan, South Korea

Location

Dong-A University

Busan, South Korea

Location

Kosin University Gospel Hospital

Busan, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Korean Cancer Center Hospital

Seoul, 139-706, South Korea

Location

Chung-Ang University Hospital

Seoul, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, 220-701, South Korea

Location

Related Publications (1)

• Kim SJ, Yoon DH, Kang HJ, Hong JY, Lee HS, Oh SY, Shin HJ, Kong JH, Yi JH, Sakamoto K, Ko YH, Huh J, Lee SS, Takeuchi K, Shin DY, Suh C, Kim WS. Ruxolitinib shows activity against Hodgkin lymphoma but not primary mediastinal large B-cell lymphoma. BMC Cancer. 2019 Nov 10;19(1):1080. doi: 10.1186/s12885-019-6303-z.

  PMID: 31707975 DERIVED

MeSH Terms

Conditions

Recurrence; Hodgkin Disease

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Won Seog Kim, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD.

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 18, 2013
• Study Start: November 15, 2013
• Primary Completion: June 30, 2017
• Study Completion: September 18, 2018
• Last Updated: November 1, 2018

Record last verified: 2018-10

Locations

KR (7)