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).

A phase II study to evaluate the activity of 177-Lu-DOTA Rituximab in adult patients with relapsed/refractory low-grade B-cell lymphomas. - 177-Lu-DOTA Rituximab Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/02/031578

Enrollment

Registered

2021-02-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C820- Follicular lymphoma grade I Health Condition 2: C821- Follicular lymphoma grade II Health Condition 3: C823- Follicular lymphoma grade IIIa Health Condition 4: C851- Unspecified B-cell lymphoma

Interventions

Intervention1: 177-Lu-Dota-Rituximab Drug: This drug has 3 parts- Rituximab, DOTA and Lutetium-177. Rituximab makes sure that the drug selectively targets cancer cells, Lutetium-177 is the chemical el

Eligibility

Inclusion criteria

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 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 9. Serum chemistry: Total Bilirubin 10. Bone marrow biopsy- Reveals 1 site of disease.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
To study the Overall Response Rates to treatment with 177Lu-DOTA-Rituximab by performing PET/CECT or a Contrast enhanced CT scan chest abdomen and pelvis at 12 weeks after therapy and BM examination for those with baseline involvement.Timepoint: To study the Overall Response Rates to treatment with 177Lu-DOTA-Rituximab by performing PET/CECT or a Contrast enhanced CT scan chest abdomen and pelvis at 12 weeks after therapy and BM examination for those with baseline involvement.	—

Measure

Time frame

To study the Overall Response Rates to treatment with 177Lu-DOTA-Rituximab by performing PET/CECT or a Contrast enhanced CT scan chest abdomen and pelvis at 12 weeks after therapy and BM examination for those with baseline involvement.Timepoint: To study the Overall Response Rates to treatment with 177Lu-DOTA-Rituximab by performing PET/CECT or a Contrast enhanced CT scan chest abdomen and pelvis at 12 weeks after therapy and BM examination for those with baseline involvement.

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Secondary

Measure	Time frame
The rate of hematological and non-hematological toxicities will be studied by adverse events monitoring- Duration and Severity of all adverse events as defined by Common Terminology Criteria for Adverse Events v5.0Timepoint: 2 years;To study the mutational profiling especially TP53 mutation among POD 24 patients and their response to Lu-DOTA-RituximabTimepoint: 2 year;2-year Overall Survival- from the time of enrollment onto the study to death due to any causeTimepoint: 2 year;2 year Progression Free Survival from the time of enrollment onto the study to progression defined as appearance of a new lesion or loss of response attained at 12 weeks, showing a more than 20% increase in the sum of longest diameters of target lesions or for small lymph nodes measuring less than 15mm post therapy, a minimum absolute increase of 5mm and the long diameter should exceed 15mm or death due to any cause whichever is earlierTimepoint: 2 year	—

Measure

Time frame

The rate of hematological and non-hematological toxicities will be studied by adverse events monitoring- Duration and Severity of all adverse events as defined by Common Terminology Criteria for Adverse Events v5.0Timepoint: 2 years;To study the mutational profiling especially TP53 mutation among POD 24 patients and their response to Lu-DOTA-RituximabTimepoint: 2 year;2-year Overall Survival- from the time of enrollment onto the study to death due to any causeTimepoint: 2 year;2 year Progression Free Survival from the time of enrollment onto the study to progression defined as appearance of a new lesion or loss of response attained at 12 weeks, showing a more than 20% increase in the sum of longest diameters of target lesions or for small lymph nodes measuring less than 15mm post therapy, a minimum absolute increase of 5mm and the long diameter should exceed 15mm or death due to any cause whichever is earlierTimepoint: 2 year

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Countries

India

Contacts

Public ContactDr Manju Sengar

Tata Memorial Center

manju.sengar@gmail.com9769690590

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026