Health Condition 1: C82- Follicular lymphoma Health Condition 2: C81- Hodgkin lymphoma Health Condition 3: C88- Malignant immunoproliferative diseases and certain other B-cell lymphomas Health Condition 4: C84- Mature T/NK-cell lymphomas Health Condition 5: C83- Non-follicular lymphoma Health Condition 6: C85- Other specified and unspecified types of non-Hodgkin lymphoma Health Condition 7: C86- Other specified types of T/NK-celllymphoma
Conditions
Interventions
Intervention1: LPEC regimen: An oral combination of Lenalidomide 10mg OD, Prednisolone 20mg OD, Etoposide 50mg OD, and celecoxib 200mg BD for 3 months
Control Intervention1: Historical control -PEPC:
Sponsors
Postgraduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Relapsed/Refractory Lymphoma Patient. 2. Patients unfit for full dose injectable chemotherapy defined as: a) Patients with an active infection at the time of starting chemotherapy defined by either a clinical, radiological or microbiological evidence of infection that would preclude immediate use of full dose anticancer regimen.18 b) Patient with compromised organ function i. Compromised cardiac function (LVEF ii. Uncontrolled COPD with poor respiratory reserve. iii. End stage liver or renal functions. iv. Dementia or any neurological deficit precluding use of full dose CT. 3. Patients not willing for injectable cytoreductive chemotherapy. 4. Absolute neutrophil count â�¥ 1000 cell / �¼l or platelet count â�¥ 50,000/�µl, not related to the primary lymphoma
Exclusion criteria
Exclusion criteria: 1. Pregnant females 2. Lactating females 3. Younger than 18 years 4. Patient suffering from uncontrolled Hepatitis B and Hepatitis C infection. 5. Central nervous system lymphoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate effectiveness of a Novel Oral metronomic chemotherapy in relapsed/refractory lymphoma, and in patients who are unfit for full dose treatment at the time of diagnosis. This effectiveness will be evaluated by comparing the lymphoma stage via Pet scan or CECT at baseline and after 3 months.Timepoint: At Baseline and 3 months post therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare change in QOL before and after starting metronomic chemotherapyTimepoint: 3 months;To compare this new regimen with historical patients treated with existing PEPC (Prednisolone/ Etoposide/ Procarbazine/ Cyclophosphamide ) metronomic regimenTimepoint: 3 months;To evaluate tolerability and drug compliance of Oral metronomic chemotherapy in lymphoma patientsTimepoint: 3 months | — |
Countries
India
Contacts
Public ContactDr Ashish Singh
PGIMER
Outcome results
None listed