Clinical trial · Interventional
Phase II Study of RT-PEPC in Relapsed Mantle Cell Lymphoma
Phase II Trial of Anti-Angiogenic Therapy With RT-PEPC in Patients With Relapsed Mantle Cell 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)
Primary Objective: Evaluate the clinical activity of the RT-PEPC combination regimen (rituximab, thalidomide, and prednisone, etoposide, procarbazine, cyclophosphamide) in patients with relapsed mantle cell lymphoma. Specifically, response rate (RR) and time to disease progression (TTP) will be assessed. Secondary Objectives: 1. Assess the toxicity profiles of RT-PEPC treatment in patients with relapsed mantle cell lymphoma. 2. Prospectively characterize the angiogenic profile of patients with mantle cell lymphoma during treatment with RT-PEPC. The dynamics of the angiogenic profile will be correlated with clinical response to RT-PEPC therapy. 3. Assess the quality of life of patients receiving RT-PEPC treatment
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 |
|---|---|---|---|
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEPC | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
| Thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study Treatment Arm
- interventionNames
- Drug: PEPC
- Drug: Thalidomide
- Drug: Rituximab
Primary outcomes (1)
- measure
- Overall Survival and Progression Free Survival
- timeFrame
- 38 months
- description
- measured by overall Response Rate (ORR), which includes Complete response and partial response.
Secondary outcomes (3)
- measure
- Asses the Toxicity Profiles
- timeFrame
- 38 months
- description
- Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of mantle cell Non-Hodgkin's Lymphoma with characteristic immunophenotypic profiles: CD5(+),CD23(-), CD19(+) or CD20(+), cyclin D1(+), and CD10(-) * Patient has persistent / recurrent disease after standard chemotherapy * Patient has not received either standard or investigational drugs within the last 3 weeks * Available frozen tumor tissue obtained since completion of last prior therapy (rebiopsy if needed) * Patient has measurable disease as defined by a tumor mass \> 1.5 cm in one dimension * Age \> 18 years * Absolute granulocyte count \> 1000 cells/mm3 * Platelet count \> 50,000 cells/mm3 * Creatinine \< 2.0 x ULN * Total bilirubin \< 2.0 x ULN * Patient has KPS \> 50% * Patient agrees to use birth control if of reproductive potential Exclusion Criteria: * Known central nervous system (CNS) involvement by lymphoma * Known HIV disease * Known peripheral neuropathy \> grade 2 * Patient is pregnant or nursing * Patient has had major surgery within the last 3 weeks * Patient is receiving other investigational drugs
References
Publications (1)
- RESULTRuan J, Martin P, Coleman M, Furman RR, Cheung K, Faye A, Elstrom R, Lachs M, Hajjar KA, Leonard JP. Durable responses with the metronomic rituximab and thalidomide plus prednisone, etoposide, procarbazine, and cyclophosphamide regimen in elderly patients with recurrent mantle cell lymphoma. Cancer. 2010 Jun 1;116(11):2655-64. doi: 10.1002/cncr.25055. PMID 20235190