Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
A Phase I Trial of BBR 2778 in Combination With Cytarabine, Methylprednisolone and Cisplatin in the Treatment of Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
NCT00053105CI-TRIAL-00002435unknownPhase 1ClinicalTrials.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 more than one drug may kill more cancer cells. PURPOSE: Phase I trial to study the effect of combination chemotherapy on the body when treating patients who have relapsed or refractory aggressive non-Hodgkin's 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| methylprednisolone | Drug | — | UNRESOLVED |
| pixantrone dimaleate | Drug | Pixantrone Dimaleate | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) including the following: * Diffuse large B-cell lymphoma * Transformed NHL * Follicular large cell lymphoma * Peripheral T-cell lymphoma * Unclassified aggressive histology (immunoblastic lymphoma) * Must have received 1 to 3 prior chemotherapy treatment regimens (may include doxorubicin up to a cumulative dose of no greater than 450 mg/m\^2) * No Burkitt's lymphoma, lymphoblastic lymphoma, or mantle cell lymphoma PATIENT CHARACTERISTICS: Age * 18 to 64 Performance status * WHO 0-1 Life expectancy * At least 3 months Hematopoietic * Neutrophil count at least 1,500/mm\^3\* * Platelet count at least 100,000/mm\^3\* NOTE: \*Lower values may be accepted if evidence of bone marrow involvement Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN)\*\* * Alkaline phosphatase no greater than 2 times ULN\*\* * AST or ALT no greater than 2 times ULN\*\* * No history or clinical symptoms of hepatitis B or C virus NOTE: \*\*Higher values may be accepted if evidence of liver involvement Renal * Creatinine no greater than 1.5 mg/dL Cardiovascular * LVEF at least 50% by MUGA * No clinically significant cardiovascular abnormalities * No New York Heart Association class II-IV heart disease * No myocardial infarction within the past 6 months * No severe arrhythmia * No uncontrolled hypertension Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 6 months after study * No history or clinical symptoms of HIV * No clinically significant neurological abnormalities * No serious uncontrolled infection (NCI CTC grade 3-4) * No condition that would place the patient at undue risk or interfere with the study results PRIOR CONCURRENT THERAPY: Biologic therapy * At least 3 months since prior radioimmunotherapy Chemotherapy * See Disease Characteristics * At least 4 weeks since prior chemotherapy * At least 1 year since prior platinum or cytarabine (unless complete response to treatment) * At least 2 years since prior fludarabine or nitrosoureas * No prior cumulative cisplatin greater than 600 mg/m\^2 Endocrine therapy * Not specified Radiotherapy * See Biologic therapy * At least 4 weeks since prior radiotherapy * No prior radiotherapy to the whole pelvis Surgery * At least 1 week since prior minor surgery and recovered * At least 4 weeks since prior major thoracic and/or abdominal surgery and recovered Other * At least 1 month since prior investigational drugs * Recovered from prior therapy * No other concurrent investigational drugs
References
Publications (0)
Data not yet available
No reference posted for this study.