Randomized Prospective Study of Early Intensification Vs Alternating Triple Therapy for Lymphoma

This study has been terminated.

First Received: June 4, 2002 Last Updated: June 23, 2005 History of Changes

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00038740

Purpose

To compare the efficacy of early intensification vs a conventional dose chemotherapy regimen for patients with intermediate grade or immunoblastic lymphoma and poor prognosis features.

Condition	Intervention
Non Hodgkin's Lymphoma	Drug: IDSHAP Drug: MBIDCOS Drug: IFOS/VP-16 Drug: NOVANTRONE Drug: HIGH DOSE BEAM

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Mitoxantrone Mitoxantrone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Randomized Prospective Study of Early Intensification Vs Alternating Triple Therapy for Patients With Poor Prognosis

Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment:	140
Study Start Date:	October 1995
Estimated Study Completion Date:	July 2002

Eligibility

Ages Eligible for Study:	15 Years to 59 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

Previously untreated patients with intermediate grade lymphoma or immunoblastic lymphoma with a tumor score >=3 (or peripheral T-cell lymphoma)
Age 15-59.
Divergent histologies including marrow involvement is allowed.
CNS involvement is allowed.

Exclusion:

Those who are unable or unlikely to be able to adhere to treatment plans or to return to Houston for follow-up visits because of geographical, economic, emotional, or social considerations.
Hepatic dysfunction, defined as a bilirubin of 2 mg%, unless the alteration is due to lymphoma.
Serum creatinine level >1.5 mg%, unless the alteration is due to lymphoma.
HIV infection.
Antecedent malignancy, whose prognosis is poor (<90% probability of surviving for 5 yrs.)
Those who will not accept transfusions of blood products or supportive care measures such as antibiotics
Those with history of chronic obstructive or restrictive lung disease will not be candidates for this study. In case of doubt and for smokers, a pulmonary consult will be requested.
Those with symptomatic heart disease ( congestive heart failure, angina, history of MI, arrhythmias) will not be eligible for this study unless cleared by the PI after cardiology consult.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038740

Locations

United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Study Chair:	Richard E Champlin, MD	M.D. Anderson Cancer Center
Study Director:	Maria A Rodriguez, MD	M.D. Anderson Cancer Center

More Information

No publications provided

Study ID Numbers:	DM95-121
Study First Received:	June 4, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00038740 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Intermediate grade Lymphoma
Immunoblastic Lymphoma
Poor prognosis Lymphoma

Study placed in the following topic categories:

Immunoproliferative Disorders
Etoposide phosphate
Lymphoma, Large-cell, Immunoblastic
Lymphoma, Small Cleaved-cell, Diffuse
Lymphatic Diseases
Lymphoma, Large-Cell, Immunoblastic
Mitoxantrone

Analgesics
Peripheral Nervous System Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Etoposide

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Sensory System Agents

Therapeutic Uses
Peripheral Nervous System Agents
Mitoxantrone
Analgesics
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Central Nervous System Agents
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009