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Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Aggressive Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00003215
First received: November 1, 1999
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining peripheral stem cell transplantation with more than one drug regimen may kill more tumor cells. It is not known whether receiving standard combination chemotherapy alone is more effective than receiving multiple combination chemotherapy plus peripheral stem cell transplantation for aggressive non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is comparing giving different combination chemotherapy regimens together with peripheral stem cell transplantation to see how well they work in treating patients with newly diagnosed aggressive non-Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Biological: filgrastim
Drug: CHOP regimen
Drug: cyclophosphamide
Drug: cytarabine
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: leucovorin calcium
Drug: melphalan
Drug: methotrexate
Drug: methylprednisolone
Drug: mitoxantrone hydrochloride
Drug: prednisone
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
Procedure: bone marrow ablation with stem cell support
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Standard Chemotherapy (CHOP Regimen) Versus Sequential High-Dose Chemotherapy With Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas and Poor Prognostic Factors: A Randomized Phase III Study (MISTRAL)

Resource links provided by NLM:


Further study details as provided by Swiss Group for Clinical Cancer Research:

Estimated Enrollment: 400
Study Start Date: April 1997
Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL)

    • Diffuse large B-cell lymphoma
    • Primary mediastinal large B-cell lymphoma
    • Anaplastic large cell lymphoma (B-cell, T-cell, or null-cell type)
  • At least two of the following risk factors:

    • Stage III or IV
    • LDH greater than upper limit of normal (ULN)
    • ECOG 2, 3, or 4
  • No CNS involvement

PATIENT CHARACTERISTICS:

Age:

  • 18 to 60

Performance status:

  • See Disease Characteristics
  • ECOG 0-4

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • No hepatitis B or C
  • AST or ALT no greater than 2 times ULN*
  • Bilirubin no greater than 2.34 mg/dL* NOTE: *Unless due to tumor involvement

Renal:

  • Creatinine clearance at least 60 mL/min (unless due to tumor involvement)

Cardiovascular:

  • No significant heart failure
  • LVEF normal
  • No active angina pectoris
  • No myocardial infarction within the past 6 months
  • No major ventricular arrhythmia

Pulmonary:

  • No significant lung disorder

Other:

  • HIV negative
  • No severe active acute or chronic infection
  • No severe psychoses
  • No prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix or nonmelanomatous skin cancer
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy for NHL (except emergency therapy, but no more than 1 course of standard chemotherapy)

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy for NHL (except emergency therapy of no greater than 600 cGy radiation)
  • No concurrent prophylactic radiotherapy to the brain

Surgery:

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003215

Locations
Austria
Allgemeines Krankenhaus der Stadt Wien
Vienna, Austria, A-1090
Germany
Dr. Horst-Schmidt-Kliniken
Wiesbaden, Germany, D-65199
Greece
Saint Savvas Cancer Hospital of Athens
Athens, Greece, 11522
Italy
European Institute of Oncology
Milano, Italy, 20141
Switzerland
Universitatsspital-Basel
Basel, Switzerland, CH-4031
Oncology Institute of Southern Switzerland
Bellinzona, Switzerland, CH-6500
Inselspital, Bern
Bern, Switzerland, CH-3010
Ratisches Kantons und Regionalspital
Chur, Switzerland, CH-7000
Hopital Cantonal Universitaire de Geneve
Collonge-Bellerive, Switzerland, CH-1245
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
Klinik Hirslanden
Zurich, Switzerland, CH-8008
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
Study Chair: Daniel C. Betticher, MD University Hospital Inselspital, Berne
  More Information

Publications:
Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00003215     History of Changes
Other Study ID Numbers: SAKK 38/97, SWS-SAKK-38/97, EU-97037
Study First Received: November 1, 1999
Last Updated: May 14, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by Swiss Group for Clinical Cancer Research:
stage I adult diffuse mixed cell lymphoma
stage I adult diffuse large cell lymphoma
stage I adult immunoblastic large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult immunoblastic large cell 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
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
anaplastic large cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cortisol succinate
Cyclophosphamide
Doxorubicin
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone-17-butyrate
Levoleucovorin
Liposomal doxorubicin
Methotrexate
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Mitoxantrone
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Vincristine
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents

ClinicalTrials.gov processed this record on November 20, 2014