Alternating Hemiplegia |
Hemiplegia Alterans |
Clinical Trial: Randomized Prospective Study of Early Intensification vs Alternating Triple Therapy for Lymphoma
This study has been terminated.
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 | Treatment or Intervention |
|---|---|
| Non Hodgkin's Lymphoma | Drug: IDSHAP Drug: MBIDCOS Drug: IFOS/VP-16 Drug: NOVANTRONE Drug: HIGH DOSE BEAM |
MedlinePlus related topics: Lymphoma
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
Expected Total Enrollment: 140
Study start: October 1995; Study completion: July 2002
Eligibility
Ages Eligible for Study: 15 Years - 59 Years, Genders Eligible for Study: Both
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.
Location Information
Richard E Champlin, MD, Study Chair, M.D. Anderson Cancer Center
Maria A Rodriguez, MD, Study Director, M.D. Anderson Cancer Center
More Information
Record last reviewed: January 2005
Last Updated: January 31, 2005
Record first received: June 4, 2002
ClinicalTrials.gov Identifier: NCT00038740
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Alternating Hemiplegia (National Institute of Neurological Disorders and Stroke)

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