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A Multicenter Phase II Study of Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin (ESHAOx) for Patients With Refractory or Relapsed Hodgkin's Lymphoma (HL)


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Hodgkin's Lymphoma

Thank you

Trial Information

A Multicenter Phase II Study of Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin (ESHAOx) for Patients With Refractory or Relapsed Hodgkin's Lymphoma (HL)


Inclusion Criteria:



- Previously histologically confirmed Hodgkin's lymphoma

- Failure to achieve a complete remission with the initial induction chemotherapy, or
recurrent disease

- Performance status (ECOG) ≤ 3

- Age ≤ 75 years old

- Number of prior chemotherapies: one or two regimens

- At least one or more uni-dimensionally measurable lesion(s) defined as; ≥ 2 cm by
conventional CT or ≥ 1 cm by spiral CT or skin lesion (photographs should be taken)
or measurable lesion by physical examination

- Adequate organ functions defined as; ANC > 1,500/ul, platelet > 75,000/ul,
transaminases < 3 X upper normal values; bilirubin < 2 mg/dL

- Written informed consent approved by institutional review board or ethic committee

Exclusion Criteria:

- Previous high dose chemotherapy with autologous stem cell transplantation or
allogeneic stem cell transplantation

- Previous chemotherapies with ESHAP regimen

- Any other malignancies within the past 5 years except skin basal cell carcinoma or
carcinoma in situ of cervix

- Other serious illness or medical conditions

- Unstable cardiac disease despite treatment, myocardial infarction within 6 months
prior to study entry

- History of significant neurologic or psychiatric disorders including dementia or
seizures

- Active uncontrolled infection (viral, bacterial or fungal infection)

- Other serious medical illnesses

- Pregnancy or breast-feeding, women of childbearing potential not employing adequate
contraception

- Previous history of drug allergy to one of the drugs in the study regimen

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Response rate to ESHAOx chemotherapy

Outcome Description:

To evaluate response rate by Cheson criteria for malignant lymphoma after 3 and 6 cycles of treatment with ESHAOx regimen in patients with refractory or relapsed Hodgkin's lymphoma.

Outcome Time Frame:

within 3 weeks after the completion of the treatment

Safety Issue:

No

Principal Investigator

Hyeon Seok Eom, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea

Authority:

Korea: Institutional Review Board

Study ID:

NCCCTS-10-524

NCT ID:

NCT01300156

Start Date:

February 2011

Completion Date:

December 2013

Related Keywords:

  • Hodgkin's Lymphoma
  • Hodgkin's disease
  • lymphoma
  • Relapsed
  • refractory
  • Hodgkin Disease
  • Lymphoma

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