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Oral chemotherapy for patients with lymphoma who are not fit/unwilling for injectable chemotherapy

Not Applicable
Completed
Conditions
Health Condition 1: C82- Follicular lymphomaHealth Condition 2: C81- Hodgkin lymphomaHealth Condition 3: C88- Malignant immunoproliferative diseases and certain other B-cell lymphomasHealth Condition 4: C84- Mature T/NK-cell lymphomasHealth Condition 5: C83- Non-follicular lymphomaHealth Condition 6: C85- Other specified and unspecified types of non-Hodgkin lymphomaHealth Condition 7: C86- Other specified types of T/NK-celllymphoma
Registration Number
CTRI/2021/07/035030
Lead Sponsor
Postgraduate Institute of Medical Education and Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
0
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 <40%).

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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To evaluate effectiveness of a Novel Oral metronomic chemotherapy in <br/ ><br>relapsed/refractory lymphoma, and in patients who are unfit for full dose treatment at <br/ ><br>the time of diagnosis. <br/ ><br>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 Outcome Measures
NameTimeMethod
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 <br/ ><br>(Prednisolone/ Etoposide/ Procarbazine/ Cyclophosphamide ) metronomic regimenTimepoint: 3 months;To evaluate tolerability and drug compliance of Oral metronomic chemotherapy in <br/ ><br>lymphoma patientsTimepoint: 3 months
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