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Chemotherapy and Radiation Therapy Plus Bone Marrow Transplantation in Treating Patients With Aggressive Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00003815
Recruitment Status : Unknown
Verified July 2001 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 17, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Bone marrow transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy and radiation therapy plus bone marrow transplantation in treating patients who have aggressive non-Hodgkin's lymphoma.


Condition or disease Intervention/treatment Phase
Lymphoma Biological: bleomycin sulfate Drug: carmustine Drug: cyclophosphamide Drug: cytarabine Drug: doxorubicin hydrochloride Drug: etoposide Drug: melphalan Drug: prednisolone Drug: vincristine sulfate Procedure: autologous bone marrow transplantation Radiation: radiation therapy Phase 3

Detailed Description:

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 1994

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003815


Locations
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United Kingdom
Newcastle Upon Tyne Hospitals NHS Trust
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Sponsors and Collaborators
Scotland and Newcastle Lymphoma Group
Investigators
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Study Chair: Stephen J. Proctor, MD, FRCP, FRCPath Newcastle-upon-Tyne Hospitals NHS Trust
More Information
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ClinicalTrials.gov Identifier: NCT00003815    
Other Study ID Numbers: CDR0000066967
SNLG-NHL-Va
EU-98032
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: July 2001
Keywords provided by National Cancer Institute (NCI):
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
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Prednisolone
Cyclophosphamide
Melphalan
Carmustine
Doxorubicin
Liposomal doxorubicin
 Etoposide
Vincristine
Bleomycin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors