A study of chemotherapy in Hodgkins lymphoma which has come back after initial treatment

Phase 2

• Conditions: Health Condition 1: C819- Hodgkin lymphoma, unspecified

• Registration Number: CTRI/2019/05/019049
• Lead Sponsor: JIPMER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 9

Inclusion Criteria

Relapsed/ refractory Hodgkin’s Lymphoma having previously received at least 1 line of standard chemotherapy

Age 5- 65 years at the time of enrolmemt

ECOG performance status 0 to 1

Written informed consent for adults over 18 years of age, and consent from parents/ legal guardian for those below 18 years of age

Negative serum pregnancy test

Female patients in the reproductive age group MUST AGREE TO use suitable contraception during the course of therapy

Patients with relapsed or refractory disease following stem cell transplantation are permitted

Acceptable bone marrow and organ function at screening as described below:

a. ANC more than 1500 per mic.L (without WBC growth factor support)

b. Platelet count more than 75,000 per mic.L;

c. Hemoglobin more than 9 g per dL

d. Total Bilirubin less than 1.5 x ULN;

e. AST (SGOT) less than 3 x ULN (less than 5 × ULN if known liver metastases)

f. ALT (SGPT) less than 3 x ULN (less than 5 × ULN if known liver metastases)

g. Serum creatinine less than 2 mg/dL or a measured creatinine clearance more than 40 mL/min

according to Cockcroft-Gault formula

Measurable disease must be present either on physical examination or imaging studies; non- measurable disease alone is not acceptable

Exclusion Criteria

f. Human Immunodeficiency Virus (HIV) infection/and or Anti-retroviral therapy and or HCV infection (patients who are anti-HCV positive but have been treated and have undetectable viral load would be permitted to be part of the study).

g. Active Hepatitis B infection (in patients who are Hepatitis B carriers, the markers of active infection such as HbeAg and HBV DNA titers must be negative and patients would be continued on appropariate prophylaxis with antivirasl throughout the duration of the study).

h. History of allogeneic transplant

i. Patient with known peptic ulcer disease/ history of GI perforation due to peptic ulcer in the past.

j. Uncontrolled medical conditions including but not limited to diabetes mellitus and hypertension.

k. Pre-existing peripheral neuropathy of > grade 1

l. Relapse within 6 months of autologous transplant

Study & Design

• Study Type: Interventional
• Study Design: Not specified