Study protocols

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This page summarises a few of the ongoing UK lymphoma trials. These many not be available in your area.

[1] UKLG LYO7 - Minimal initial therapy (MIT) for "early" Hodgkin's disease

A multicentr randomised trial of short neoadjuvant chemotherapy (VAPEC-B) plus involved field radiotherapy (MIT) versus mantle radiotherapy.

Objectives

  1. Overall and Hodgkin’s specific survival at 5, 10 and 15 years.
  2. Freedom from relapse/progression at 5 an 10 years.
  3. Quality of life (selected centre)
  4. Late effects of treatment on key organ function.

Eligibility criteria

  1. Males and females between 16 - 75 years.
  2. Histologically proven Hodgkin’s Disease of clinical stage IA or IIA with no mediastinal bulk.
  3. No previous treatment.


Chemotherapy

VAPEC-B see chemotherapy section

Radiotherapy

Involved field - see radiotherapy section

Contact numbers

Dr MV Williams

Addenbrooke’s Hospital, Cambridge. 01223 217020

Dr JA Radford

The Christie Hospital, Manchester. 0161 446 3000 ex 3753

Randomisation

Dr G Vaughan Hudson BNLI 0171 631 4787 or 0171 380 9428

 

 

[2] BNLI-1 - Study of poor risk intermediate or high grade NHL

Objectives Of Study

To assess in a prospective randomised trial the value of early intensification with autologous bone marrow or stem cell support in patients with poor prognosis intermediate/high grade Non-Hodgkin's Lymphomas.

Study Design

Patient randomisation, 3 cycles of CHOP followed by response assessment. If responding patient proceeds to next stage which is either further CHOP to CR + 2 (min 6) cycles or BEAM + ABMT as decided at randomisation.

Patient Selection

Age 16 - 65 years

No medical conditions prohibiting intensive therapy.

No systemic treatment for cancer in previous 5 years.

Histology follicular large cell lymphomas

diffuse mixed cell lymphomas

diffuse large cell lymphomas

diffuse immunoblastic lymphomas

All histology to be reviewed by panel (to be established). This can be done after randomisation and where necessary patients will subsequently be excluded from the study.

Poor prognostic features defined as the presence of 2 or 3 of :

i stage III/IV

ii LDH > normal

iii Performance status 2-4 (ECOG - WHO)

Full clinical staging to include CT scanning of abdomen and bone marrow trephine biopsy.

 

Randomisation (within 2 weeks of starting chemotherapy):

Dr G Vaughan Hudson. Tel 071 631 4787 or 071 380 9428 (direct lines)

Fax 071 380 9427

 

Beam + ABMT

High dose therapy and ABMT to be carried out in weeks 9 or 10. Although this is a very narrow window, the early randomisation will allow "booking of harvest dates" two months in advance. Full details in protocol folder.

 

[3] BNLI - 2 Study of chemotherapy in elderly patientss (PAdriaCEBO v PMitCEBO)

Aims Of Current Trial

  1. To create a database on unselected elderly patients with high grade NHL
  2. To establish the CR rate, overall survival and disease specific survival obtained with an eight week seven drug regimen
  3. To compare the efficacy of PAdriaCEBO and PMitCEBO
  4. To determine whether the substitution of adriamycin by mitozantrone results in less toxicity and improved quality of life.

Eligibility criteria

  1. Age 60-85 years
  2. All histology to be reviewed by central BNLI panel
  3. Stage IB - IV

Exclusion Criteria

  1. Patients must be free from any other irreversible medical condition that would drastically limit their lifespan or prohibit the sue of combination chemotherapy.
  2. Patients with significant non/para malignant renal/hepatic/cardiac dysfunction.
  3. Lymphoblastic and Burkitt's lymphoma.

Randomisation

To be carried out by telephone to the BNLI Secretariat on 071 631 4787 (direct line)

or 071 636 8333 Ext 3233/3234 before starting any therapy

Details of Protocol - see chemotherapy protocols

 

[4] LYO3 study

A protocol for a randomised trial of observation versus chlorambucil after anti-heliocbacter therapy in low grade gastric lyphoma.

All patients have anti-heliobacter treatment (see above)

[A] CR - observation or Chlb

[B] PR - observation or Chlb

Randomisation number 0171 631 4787.

[5] LYO4 study 

A study to investigate the benefit of adjuvant chemotherapy following resection of localised gastrintestinal intermediate and immunoblastic high grade NHL and to assess the effect of the depth of penetration of the tumour on survival.

All patients are required to have complete surgical resection

[A] T1-2, N0,M0 either CHOP x3 or observation only

[B] T3-4, n0-2, M0 either CHOP x3 or CHOP x6

CLINICAL Co-ORDINATOR - Dr David Cunningham RMH Sutton.

Randomisation number 0171 631 4787.

[6] LY09 study

A randomised trial of chemotherapytherapy in advanced Hodgkin’s disease

Eligibility: Stage IB, IIB, III & IV. Stage IA with bulky disease ( Def: Mediastinal mass > 1/3 rd the interthoracic ratio at d5/6. or a nodal mass > 10 cm). Stage IIA with 3 or more sites of disease or bulky disease.

[A] ABVD

[B] ChlVPP/PABLOE or hybrid BEACOP.

 


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