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Combination Chemotherapy With or Without Donor Bone Marrow Transplantation in Treating Infants With Previously Untreated Acute Lymphoblastic Leukemia

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00022126
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Bone marrow transplantation allows the doctor to give higher doses of chemotherapy and kill more cancer cells.

PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy with or without donor bone marrow transplantation in treating infants who have previously untreated acute lymphoblastic leukemia.


Condition Intervention Phase
Leukemia
Drug: asparaginase
Drug: cyclophosphamide
Drug: cyclosporine
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: mercaptopurine
Drug: methotrexate
Drug: methylprednisolone
Drug: pegaspargase
Drug: thioguanine
Drug: vincristine sulfate
Procedure: allogeneic bone marrow transplantation
Procedure: radiation therapy
Phase II

MedlinePlus related topics:   Bone Marrow Transplantation    Cancer    Leukemia, Childhood   

Drug Information available for:   Doxorubicin    Doxorubicin hydrochloride    Cyclophosphamide    Cytarabine    Cytarabine hydrochloride    Mercaptopurine    6-Mercaptopurine    L-Asparaginase    Daunorubicin hydrochloride    Daunorubicin    Dexamethasone    Dexamethasone acetate    Dexamethasone Sodium Phosphate    Doxiproct plus    Methotrexate    Methylprednisolone    Vincristine sulfate    Vincristine    Cyclosporin    Cyclosporine    Thioguanine    Pegaspargase   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Study of Modified Augmented BFM Therapy for Infants With Acute Lymphoblastic Leukemia

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

Study Start Date:   November 2002

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of previously untreated acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia

    • CNS or testicular disease allowed
  • No L3 sIg+ ALL or acute myelogenous leukemia
  • At least 36 weeks gestation for congenital ALL

PATIENT CHARACTERISTICS:

Age:

  • Under 366 days at diagnosis

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Steroid therapy within 48 hours of study allowed if complete blood counts and lumbar puncture results known
  • No chronic steroid treatment for other disease

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No other concurrent cytotoxic therapy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022126

Show 51 study locations  Show 51 Study Locations

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Paul S. Gaynon, MD     Children's Hospital Los Angeles    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068787, COG-AALL01P1
First Received:   August 10, 2001
Last Updated:   August 23, 2008
ClinicalTrials.gov Identifier:   NCT00022126
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
untreated childhood acute lymphoblastic leukemia  
L1 childhood acute lymphoblastic leukemia  
L2 childhood acute lymphoblastic leukemia  
acute undifferentiated leukemia  

Study placed in the following topic categories:
Dexamethasone
Daunorubicin
Leukemia, Lymphoid
Cyclosporine
Clotrimazole
Methylprednisolone
Miconazole
Prednisolone acetate
6-Mercaptopurine
Cyclophosphamide
Cyclosporins
Leukemia
Pegaspargase
Methotrexate
Lymphoma
Dexamethasone acetate
Cytarabine
Methylprednisolone Hemisuccinate
Asparaginase
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Thioguanine
Tioconazole
Vincristine
Methylprednisolone acetate
Doxorubicin
Folic Acid
Lymphatic Diseases
Prednisolone
Lymphoproliferative Disorders

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Reproductive Control Agents
Antibiotics, Antineoplastic
Neuroprotective Agents
Hormones
Therapeutic Uses
Antifungal Agents
Abortifacient Agents
Alkylating Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Mitosis Modulators
Gastrointestinal Agents
Enzyme Inhibitors
Antimitotic Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Protective Agents

ClinicalTrials.gov processed this record on December 03, 2008




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