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Combination Chemotherapy in Treating Adults With Acute Lymphocytic Leukemia
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsored by: Klinikum der J.W. Goethe Universitaet
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002531
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Randomized phase II trial to study the effectiveness of various combination chemotherapy regimens in treating patients with acute lymphocytic leukemia.


Condition Intervention Phase
Leukemia
Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: leucovorin calcium
Drug: mercaptopurine
Drug: methotrexate
Drug: mitoxantrone hydrochloride
Drug: prednisolone
Drug: teniposide
Drug: thioguanine
Drug: vincristine sulfate
Drug: vindesine
Procedure: allogeneic bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: MULTICENTRE TRIAL OF INTENSIFIED THERAPY FOR ADULT ALL (O5/93)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 1993
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Diagnosis of low-risk acute lymphocytic leukemia (ALL) (common ALL or pre-B-cell) Must meet 1 of the following 2 conditions:

Age 51 to 65 and meets the following criteria: No mediastinal mass No T-cell or B-cell disease Age 15 to 50 and meets the following criteria:

Philadelphia chromosome (Ph) negative bcr-abl negative Initial WBC less than 30,000/mm3 OR Diagnosis of T-cell ALL with or without mediastinal involvement Age 15 to 50 OR Diagnosis of high-risk ALL (common ALL or pre-B-cell) Age 15 to 50 and meets 1 of the following criteria: Ph positive bcr-abl positive Pre-pre-B-cell disease, i.e., t(4;11) Initial WBC greater than 30,000/mm3 OR Diagnosis of B-cell ALL

PATIENT CHARACTERISTICS: Age: See Disease Characteristics 15 to 65 Performance status: Not specified Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: No renal failure Cardiovascular: No cardiomyopathy Other: HIV-1 and HIV-2 negative No severe psychiatric disease

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytostatic drugs except vincristine Endocrine therapy: Prior corticosteroids allowed Radiotherapy: Not specified Surgery: Not specified Other: No more than 2 weeks of prior therapy No other prior cytostatic drugs

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002531

Locations
Germany
Klinikum der J.W. Goethe Universitaet
Frankfurt, Germany, D-60590
Sponsors and Collaborators
Klinikum der J.W. Goethe Universitaet
Investigators
Study Chair: Dieter Hoelzer, MD, PhD Klinikum der J.W. Goethe Universitaet
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000078421, GER-GMALL-ALL-05/93, EU-93002
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00002531     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
untreated adult acute lymphoblastic leukemia
T-cell adult acute lymphoblastic leukemia
B-cell adult acute lymphoblastic leukemia
non-T, non-B adult acute lymphoblastic leukemia

Study placed in the following topic categories:
Dexamethasone
Anti-Inflammatory Agents
Methylprednisolone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
6-Mercaptopurine
Hormones
Methotrexate
Etoposide
Methylprednisolone Hemisuccinate
Asparaginase
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Thioguanine
Vincristine
Glucocorticoids
Doxorubicin
Folic Acid
Teniposide
Mitoxantrone
Antineoplastic Agents, Phytogenic
Antimetabolites
Daunorubicin
Leukemia, Lymphoid
Immunologic Factors
Vindesine
Folate
Leucovorin

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Dexamethasone
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
6-Mercaptopurine
Hormones
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Asparaginase
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Immune System Diseases
Thioguanine
Vincristine
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Doxorubicin
Teniposide
Neoplasms
Mitoxantrone
Antineoplastic Agents, Phytogenic
Antimetabolites

ClinicalTrials.gov processed this record on July 02, 2009