Outpatient-based fractionated Ifosfamide, Carboplatin, Etoposide (ICE) chemotherapy supported with pegfilgrastim for salvage and stem cell mobilisation in transplant eligible patients with relapsed or refractory diffuse large B-cell lymphoma and Hodgkin lymphoma

Phase 2

Recruiting

• Conditions: Relapsed or refractory diffuse large B-cell lymphoma and Hodgkin lymphoma; Cancer - Hodgkin's; Cancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

• Registration Number: ACTRN12606000350527
• Lead Sponsor: Amgen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-08-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Eastern Co-operative Oncology Group performance status 0, 1 or 2. 2. Relapsed or progressive non-Hodgkin lymphoma (WHO diffuse large B-cell) including induction failures to first-line anthracycline-containing regimens; or relapsed or refractory Hodgkin lymphoma. 3. Intended for chemo-responsive patients to proceed to autologous peripheral blood stem cell transplantation 4. Minimum life expectancy of 3 months 5. Able to give written informed consent.

Exclusion Criteria

1. More than one regimen of previous chemotherapy treatment2. Past history of severe cardiac, hepatic, respiratory or renal disease. 3. Poor renal function (serum creatinine > 150 µmol/L or 1.5-2.0 x ULN), poor hepatic function (bilirubin >30 µmol/L or >1.5x Upper Limit of Normal (ULN); transaminases>2.5 x ULN) unless these abnormalities are related to lymphoma.4. Poor bone marrow reserve as defined by neutrophils <1.5 x 109/L or platelets <100 x 109/L unless related to bone marrow infiltration.5. HIV seropositive6. Pregnant women or breast-feeding mothers7. Those in whom high dose chemotherapy as conditioning for autologous stem cell transplantation would be otherwise precluded.8. Previous radiotherapy to >20% bone marrow 9. Previous bone marrow or PBSC transplant10. History of cancer within the previous 5 years except non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma.11. Known hypersensitivity to E coli-derived proteins.

Study & Design

• Study Type: Interventional
• Study Design: Not specified