Clinical trial · Interventional
Outpatient Administration of R-DHAP in Relapsed/Refractory Non-Hodgkin Lymphoma
Safety and Efficacy of an Outpatient Schedule of Rituximab, Cytarabine, Carboplatin, and Dexamethasone in Relapsed/Refractory Non-Hodgkin Lymphoma. Phase I/II Trial.
NCT03892421CI-TRIAL-00051863completedPhase 1 / Phase 2ClinicalTrials.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)
The goal of this study is to evaluate the efficacy and safety of a combination of the anti-CD20 monoclonal antibody Rituximab, Dexamethasone, daily high dose Cytarabine twice, and Carboplatin; delivered in an outpatient setting.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Relapsed Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cytarabine Injection | Drug | Cytarabine | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Filgrastim 0.3 MG/ML | Drug | Filgrastim | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Modified DHAP
- description
- Rituximab 375 mg/m² day 1, i.v. Carboplatin AUC(Area Under Curve) 5 day 1, i.v. Cytarabine 2000 mg/m², on day 2 and 3, i.v. Dexamethasone 40 mg, days 1-4, i.v. Filgrastim 300 mcg, days 10-15, s.c.
- interventionNames
- Drug: Rituximab
- Drug: Carboplatin
- Drug: Cytarabine Injection
- Drug: Dexamethasone
- Drug: Filgrastim 0.3 MG/ML
Primary outcomes (2)
- measure
- Overall Response Rate
- timeFrame
- 63 days
- description
- The percentage of patients which showed either a partial remission (PR), or a complete remission (CR) after study treatment.
- measure
- Incidence of hematological toxicities > grade 2 by Common Terminology Criteria V4.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of recurrent or refractory B-cell non-Hodgkin lymphoma * Performance status: Eastern Cooperative Oncology Group 0-2 * At least three weeks from last chemotherapy * Toxicities by Common Terminology Criteria Version 4.0 ≤ 1 * Glomerular filtration rate \>50 ml/min * Women of childbearing potential must use effective methods of contraception Exclusion Criteria: * Post-transplant relapse of lymphoma * Central nervous system involvement of lymphoma * Serious infections * Known allergies to one or more of the experimental drugs * Diabetes with glucose \>200 mg/dl * Pregnant or lactating females * Known HIV or B Hepatitis positivity * Known allergies to filgrastim
References
Publications (4)
- BACKGROUNDVelasquez WS, Cabanillas F, Salvador P, McLaughlin P, Fridrik M, Tucker S, Jagannath S, Hagemeister FB, Redman JR, Swan F, et al. Effective salvage therapy for lymphoma with cisplatin in combination with high-dose Ara-C and dexamethasone (DHAP). Blood. 1988 Jan;71(1):117-22. PMID 3334893
- BACKGROUNDMomparler RL. Optimization of cytarabine (ARA-C) therapy for acute myeloid leukemia. Exp Hematol Oncol. 2013 Aug 6;2:20. doi: 10.1186/2162-3619-2-20. eCollection 2013. PMID 23919448
- BACKGROUNDYanik G, Yousuf N, Miller MA, Swerdlow SH, Lampkin B, Raza A. In vivo determination of cell cycle kinetics of non-Hodgkin's lymphomas using iododeoxyuridine and bromodeoxyuridine. J Histochem Cytochem. 1992 May;40(5):723-8. doi: 10.1177/40.5.1573252. PMID 1573252
- BACKGROUNDSandlund JT, Santana VM, Hudson MM, Onciu M, Head D, Murry DJ, Ribeiro R, Wallace D, Rencher R, Pui CH. Combination of dexamethasone, high-dose cytarabine, and carboplatin is effective for advanced large-cell non-Hodgkin lymphoma of childhood. Cancer. 2008 Aug 15;113(4):782-90. doi: 10.1002/cncr.23630. PMID 18618501