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Phase III Trial comparing CHOP to PmitCEBO in Good Risk patients with Histologically Aggressive Non-Hodgkin's Lymphoma

Phase III Trial comparing CHOP to PmitCEBO in Good Risk patients with Histologically Aggressive Non-Hodgkin's Lymphoma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN23628366
Enrollment
Unknown
Registered
2002-08-19
Start date
1998-12-10
Completion date
Unknown
Last updated
2019-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma (non-Hodgkin's) Cancer Other and unspecified types of non-Hodgkin's lymphoma

Interventions

1. CHOP regimen: Chemotherapy with cyclophosphamide, doxorubicin, vincristine and prednisolone repeated every 21 days for 6-8 cycles 2. PmitCEBO regimen: Chemotherapy with mitoxantrone

Sponsors

British National Lymphoma Investigation (BNLI) (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Previously untreated non-Hodgkin's Lymphoma of the following types: follicular large cell lymphoma, diffuse mixed cell lymphoma diffuse large cell lymphoma diffuse immunoblastic lymphoma 0r Revised European/American Lymphoma (REAL) classification: diffuse large B peripheral T cell lymphoma 2. Bulky stage IA and stages IB-IV (Ann Arbour staging system) 3. Age 18-59 years 4. Measurable or evaluable disease 5. Good prognosis, defined as the presence of no more than one of the following adverse features: Stage III/IV Lactic dehydrogenase (LDH) >upper limit of normal Performance status 2-4 (Eastern Cooperative Oncology Group [ECOG]-World Health Organisation [WHO]) Adequate bone marrow function, indicated by Haemoglobin =10 g/dL Neutrophils =2 x 10^9/L Platelets =100 x 10^9/L 6. Written informed consent

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
Not provided at time of registration

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026