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Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Aggressive Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsored by: Swiss Group for Clinical Cancer Research
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003215
  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 III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
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 National Cancer Institute (NCI):

Estimated Enrollment: 400
Study Start Date: April 1997
  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
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
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
Hopital Cantonal Universitaire de Geneve
Collonge-Bellerive, Switzerland, CH-1245
Universitatsspital-Basel
Basel, Switzerland, CH-4031
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
Klinik Hirslanden
Zurich, Switzerland, CH-8008
Oncology Institute of Southern Switzerland
Bellinzona, Switzerland, CH-6500
Ratisches Kantons und Regionalspital
Chur, Switzerland, CH-7000
Inselspital, Bern
Bern, Switzerland, CH-3010
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
Study Chair: Daniel C. Betticher, MD University Hospital Inselspital, Berne
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000066075, SWS-SAKK-38/97, EU-97037
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00003215     History of Changes
Health Authority: United States: Federal Government

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 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

Study placed in the following topic categories:
Anti-Inflammatory Agents
Prednisone
Anti-Infective Agents
Hydrocortisone
Methylprednisolone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Lymphoma, Large-Cell, Anaplastic
Methotrexate
Aggression
Etoposide
Methylprednisolone Hemisuccinate
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Vincristine
Glucocorticoids
Doxorubicin
Folic Acid
Hydrocortisone acetate
Mitoxantrone
Lymphoma, Non-Hodgkin
Antineoplastic Agents, Phytogenic
Antimetabolites
Melphalan
Immunologic Factors
Folate
Leucovorin

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Prednisone
Anti-Infective Agents
Hydrocortisone
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Methylprednisolone
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Methylprednisolone Hemisuccinate
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Immune System Diseases
Vincristine
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Doxorubicin
Neoplasms
Hydrocortisone acetate
Mitoxantrone
Lymphoma, Non-Hodgkin
Antineoplastic Agents, Phytogenic
Antimetabolites

ClinicalTrials.gov processed this record on September 01, 2009