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A Randomised Study of High Dose Chemotherapy/Radiotherapy and Autologous Bone Marrow Transplantation in Patients With High Grade Malignant Non-Hodgkin's Lymphoma (Kiel Classification) According to Prognostic Groups


Phase 3
15 Years
65 Years
Open (Enrolling)
Both
Lymphoma

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Trial Information

A Randomised Study of High Dose Chemotherapy/Radiotherapy and Autologous Bone Marrow Transplantation in Patients With High Grade Malignant Non-Hodgkin's Lymphoma (Kiel Classification) According to Prognostic Groups


OBJECTIVES:

- Assess the rate of remission in patients with aggressive non-Hodgkin's lymphoma treated
with high-dose chemotherapy and radiotherapy plus autologous bone marrow
transplantation.

- Determine the efficacy and toxic effects of this regimen in these patients.

OUTLINE: This is a randomized, placebo-controlled, multicenter study. Patients are
stratified according to risk group (good vs intermediate vs poor).

Patients undergo harvest of autologous bone marrow stem cells after priming chemotherapy and
before transplantation.

Patients receive induction chemotherapy comprising the CHOP or VAPEC-B regimen. The CHOP
regimen consists of vincristine (VCR) IV, cyclophosphamide (CTX) IV, and doxorubicin (DOX)
IV on day 1 and oral prednisolone (PRDL) on days 1-5. Treatment repeats every 3 weeks for
six courses. The VAPEC-B regimen consists of DOX IV on days 1, 15, 29, 43, 57, and 71; CTX
IV on days 1, 29, and 57; VCR IV on days 8, 22, 36, 50, and 64; bleomycin IV on days 8, 36,
64; oral etoposide (VP-16) on days 15-19, 43-47, and 71-75; and oral PRDL daily for 13
weeks.

Patients then may undergo radiotherapy for 2-3 weeks to areas of original bulk or residual
disease.

- Good-risk group: Patients are randomized to one of two treatment arms.

- Arm I: Patients receive no further treatment.

- Arm II: Patients receive melphalan (L-PAM) before or after total body irradiation
(TBI), which is delivered in 3 fractions over 24 hours. After completion of
radiotherapy, patients undergo autologous bone marrow transplantation (AuBMT).

- Intermediate- or poor-risk group: Patients are randomized one of three treatment arms.

- Arm III: Patients receive L-PAM IV on day -2 and AuBMT on day 0.

- Arm IV: Patients receive treatment as in arm II.

- Arm V: Patients receive carmustine IV on day -6, VP-16 IV once daily and
cytarabine IV twice daily on days -5 to -2, and L-PAM IV on day -1. Radiotherapy
to bulk disease begins after completion of chemotherapy. Patients undergo AuBMT on
day 0.

Patients are followed monthly for 3 months, every 2 months for 1 year, every 4 months for 2
years, and then every 6 months thereafter.

PROJECTED ACCRUAL: Not specified

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed aggressive non-Hodgkin's lymphoma requiring chemotherapy

- Stage II, III, or IV

- B cell:

- Centroblastic

- Immunoblastic

- Large cell anaplastic

- Non-Burkitt lymphoblastic

- T cell:

- Pleomorphic medium cell

- Pleomorphic large cell

- Immunoblastic

- Large cell anaplastic

- Lymphoblastic

- No Burkitt (L3) subtype

- No large mediastinal mass OR

- Stage I, II, III, or IV

- Bulk disease greater than 10 cm

- Nodal or extranodal site

- No primary localized gut lymphoma

- No CNS involvement

PATIENT CHARACTERISTICS:

Age:

- 15 to 65

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- No concurrent bone marrow dysplastic syndromes

Hepatic:

- Bilirubin no greater than 2.5 times upper limit of normal (ULN)

Renal:

- Creatinine no greater than 2.5 times ULN

Other:

- No other malignancy except skin cancer or stage I cervical cancer

- Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Stephen J. Proctor, MD, FRCP, FRCPath

Investigator Role:

Study Chair

Investigator Affiliation:

Newcastle-upon-Tyne Hospitals NHS Trust

Authority:

United States: Federal Government

Study ID:

CDR0000066967

NCT ID:

NCT00003815

Start Date:

June 1994

Completion Date:

Related Keywords:

  • Lymphoma
  • stage I adult diffuse mixed cell lymphoma
  • stage I adult diffuse large cell lymphoma
  • stage I adult immunoblastic large cell lymphoma
  • stage I adult lymphoblastic lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • contiguous stage II adult diffuse mixed cell lymphoma
  • contiguous stage II adult immunoblastic large cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • contiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

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