Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Lymphoma
A Randomized Prospective Study of Early Intensification Versus Alternating Triple Therapy for Patients With Poor Prognosis Lymphoma
NCT00002835CI-TRIAL-00035818completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy in treating patients who have intermediate-grade or immunoblastic lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (18)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bleomycin Sulfate (BLM) | Biological | Bleomycin | ALIAS |
| Carmustine | Drug | Carmustine | ALIAS |
| Cisplatin (CDDP) | Drug | Cisplatin | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine (ARA-C) | Drug | Cytarabine | ALIAS |
| Etoposide (VP-16) | Drug | Etoposide | ALIAS |
| Filgrastim (G-CSF) | Biological | Filgrastim | ALIAS |
| Idarubicin | Drug | Idarubicin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 3 courses of early intensification: First course: Ifosfamide (IFF) IV continuously and Etoposide (VP-16) IV over 2 hours every 12 hours on days 1-3. Filgrastim (G-CSF) administered subcutaneously (SC) beginning on day 5 and continuing until blood counts recover then autologous peripheral blood stem cells (PBSC) are harvested, selected for CD34 positive cells, and purged in vitro. If more than 5% of the WBC contains lymphoma cells after induction, then 2 courses of IFF and VP-16 are administered before PBSC harvest. Second course: IFF IV continuously on days 1-3, mitoxantrone (DHAD) IV on day 1, and G-CSF SC as in first course. Third course: Carmustine IV over 1 hour on day -6, ARA-C and VP-16 IV every 12 hours on days -5 to -2, and melphalan IV on day -1. PBSC are reinfused on day 0. G-CSF is administered SC beginning on day 0 and continuing until blood counts recover. Each course lasts 3 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: Filgrastim (G-CSF)
- Drug: Carmustine
- Drug: Cytarabine (ARA-C)
- Drug: Etoposide (VP-16)
- Drug: Ifosfamide
- Drug: Melphalan
- Drug: mitoxantrone hydrochloride (DHAD)
- Procedure: Peripheral Blood Stem Cell Transplantation
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 59 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of previously untreated intermediate-grade or immunoblastic lymphoma
* Tumor score of 3 or greater, defined by the presence of 3 or more of the following criteria :
* Ann Arbor stage III or IV disease
* B symptoms (fever, sweats, and weight loss greater than 10%)
* At least 1 tumor mass greater than 7 cm or mediastinal mass visible on plain chest x-ray
* Beta-2 microglobulin at least 3.0
* Lactic dehydrogenase at least 1.1 times the upper limit of normal
* T- and B-cell lymphomas allowed if intermediate grade or immunoblastic
* Divergent histologies, including bone marrow involvement, allowed
* CNS involvement allowed NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
* 15 to 59
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin less than 2.0 mg/dL (unless elevation due to lymphoma)
Renal:
* Creatinine no greater than 1.5 mg/dL (unless elevation due to lymphoma)
Cardiovascular:
* LVEF greater than 50% by echocardiogram if over age 45
* No congestive heart failure, angina, history of myocardial infarction, or arrhythmia unless cleared by principal investigator after cardiology consultation
Pulmonary:
* No history of chronic obstructive or restrictive lung disease
* Pulmonary consultation required for smokers or patients with questionable lung function
Other:
* HIV negative
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No prior malignancy with poor prognosis (less than 90% probability of surviving for 5 years)
* No geographic, economic, emotional, or social condition that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior biologic therapy
Chemotherapy
* No prior chemotherapy
Endocrine therapy
* No prior endocrine therapy
Radiotherapy
* No prior radiotherapy
Surgery
* Not specifiedReferences
Publications (0)
Data not yet available
No reference posted for this study.