A study to evaluate the effectiveness of 177-Lu-DOTA Rituximab drug in adult patients diagnosed with the recurrence of low-grade B-cell lymphomas (a type of blood cancer).

Phase 2

• Conditions: Health Condition 1: C820- Follicular lymphoma grade IHealth Condition 2: C821- Follicular lymphoma grade IIHealth Condition 3: C823- Follicular lymphoma grade IIIaHealth Condition 4: C851- Unspecified B-cell lymphoma

• Registration Number: CTRI/2021/02/031578
• Lead Sponsor: Tata Research Administrative Council TRAC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Life expectancy of patients > 3 months.

2.ECOG PS 0-2

3.CD20 positive Low-grade B-cell Non-Hodgkinâ??s lymphoma.

a.Follicular lymphoma Grade 1-3a,

b.Marginal zone lymphoma

c.Other indolent lymphomas.

4.Relapsed disease < 2years from previous therapy or

5.Relapsed disease > 2 years from R-chemo, if a re-challenge is not feasible. (Who have received at least 2 lines of chemotherapy that includes Bendamustine/Anthracycline based regimen orcurrently ineligible for anthracyclines.)

6.No cytotoxic chemotherapy administered in the past 6 weeks, other than a prephase (steroid based).

7.Last Rituximab administration at least 6 months before the date of enrolment.

8.Hematological condition: ANC > 1500/mm3, Platelet count > 100,000/mm3, ALC < 5000/mm3 within a week from the start of treatment

9.Serum chemistry: Total Bilirubin < 1.5mg/dL, unless predominantly unconjugated hyperbilirubinemia. ALT < 2.5 times the Upper limit of normal.

10.Bone marrow biopsy- Reveals < 25% infiltration by tumor cells and >1 site of disease.

Exclusion Criteria

1. Radiation to pelvis, femoral or lumbar spine in the past.

2. Active CNS lymphoma.

3. Mantle Cell Lymphoma and Large Cell Transformation of indolent lymphoma

4. Known case of Hepatitis B, C or HIV.

Study & Design

• Study Type: Interventional
• Study Design: Not specified