Clinical trial · Interventional
Combination Chemotherapy Plus Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
A Phase II Trial of Cisplatinum, Cytosine Arabinoside, Dexamethasone (DHAP) With Rituxan in Patients With Relapsed CD20+ B-Cell Non-Hodgkin's Lymphoma
- 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. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining combination chemotherapy with monoclonal antibody therapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus rituximab in treating patients who have relapsed 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
| sargramostim | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- rituximab+dexamethasone+cisplatin+cytarabine+sargramostim
- description
- Patients receive rituximab IV on days 1, 8, 15, and 22 for the first course only. Patients receive dexamethasone orally or IV on days 1-4, cisplatin IV continuously for 24 hours on day 1, cytarabine IV over 3 hours every 12 hours for 2 doses on day 2, and sargramostim (GM-CSF) subcutaneously on days 3-12 or until blood counts recover. Chemotherapy repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
- interventionNames
- Biological: rituximab
- Drug: cisplatin
- Drug: cytarabine
- Drug: dexamethasone
- Drug: sargramostim
Primary outcomes (1)
- measure
- response
- timeFrame
- Up to 5 years
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed CD20+ B-cell non-Hodgkin's lymphoma * Relapsed following chemotherapy and eligible for platinum-containing regimen * Measurable disease * Must be at least 1.5 x 1.5 cm PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 75,000/mm\^3 Hepatic: * Bilirubin no greater than 2.0 mg/dL Renal: * Creatinine no greater than 1.5 times upper limit of normal Cardiovascular: * No uncontrolled hypertension Other: * HIV negative * No other active malignancy * No uncontrolled diabetes mellitus * No uncontrolled peptic ulcer disease * No uncontrolled infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception
References
Publications (1)
- RESULTWitzig TE, Geyer SM, Kurtin PJ, Colgan JP, Inwards DJ, Micallef IN, LaPlant BR, Michalak JC, Salim M, Dalton RJ, Moore DF Jr, Reeder CB; North Central Cancer Treatment Group. Salvage chemotherapy with rituximab DHAP for relapsed non-Hodgkin lymphoma: a phase II trial in the North Central Cancer Treatment Group. Leuk Lymphoma. 2008 Jun;49(6):1074-80. doi: 10.1080/10428190801993470. PMID 18569634