Clinical trial · Interventional
Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Rituximab Pateinets With Aggresive NHL
Protocol CCAM 05-02 " Phase I-II Study of Dose Dense of PEG Filgrastim and GM-CSF as Support for Dose Desnse CHOP-R Front Line Therapy for Aggressive Non Hodgkin's Lymphoma"
NCT01527422CI-TRIAL-00006215CHOP-RcompletedPhase 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)
We now propose to investigate the combination of CHOP-Rituxan plus PEG-Filgrastim (PEG-filgrastim) and GM-CSF. PEG-Filgrastim would be given in order to allow us to administer the chemotherapy courses every 2 weeks with the practical advantage of requiring only one dose of PEG-filgrastim instead of daily doses of G-CSF.
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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Non Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide, Doxorubicin, Vincristine and Prednisone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Phase I-II Study of Dose Dense of PEG-Filgrastim and GM-CSF combined with CHOP-R
- timeFrame
- up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with previously untreated aggressive non-Hodgkin's Lymphoma. Aggressive histologies include follicular large cell, diffuse large cell, peripheral T cell, transformed lymphomas, Lymphoblastic lymphomas, Burkitt and Burkitt like lymphomas. * Must have measurable or evaluable disease. * Stage I-IV patients are eligible * Patients must be 18 years or older. * No evidence of grade 3 or more neurosensory or neuromotor dysfunction (see appendix- toxicity criteria) * Written Consent Exclusion Criteria: * HIV positive patients and those with Hepatitis B or C will be excluded from this protocol. * Patients with inadequate bone marrow and organ function as defined below: * Neutrophils \<1,000/l * Platelets \<100,000/l * Billirubin \>2 * Creatinine \>2.0 or estimated CrCl \<30 cc/min * CNS involvement by Lymphoma. * Uncontrolled intercurrent disease including arrhythmias, angina pectoris, Class III-IV Congestive heart failure (CHF symptoms on less than ordinary exertion or at rest) or active infection. * Active infection or fever \> 38.2 degrees C unless due to lymphoma. * Subject is not using adequate contraceptive precautions. * Pregnancy or breast feeding
References
Publications (0)
Data not yet available
No reference posted for this study.