A study to compare whether administering rituximab slowly based on skin test reduces allergic reactions in patients with blood cancer compared to routine administration

Skin test-guided administration of Rituximab to reduce hypersensitivity reactions compared to standard administration in hematological malignancies An investigator-initiated, randomized, open-label trial - RITE Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/090469

Enrollment

206

Registered

2025-07-08

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Health Condition 1: C81-C96- Malignant neoplasms of lymphoid, hematopoietic and related tissue

Interventions

Intervention1: Skin Test-Guided Rituximab Administration Arm: All patients will undergo Skin test with rituximab. Patients with positive skin test will undergo rituximab administration by desensitizat

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age more than equal to 18 years 2. Confirmed diagnosis of haematological malignancies 3. Planned for the first cycle of rituximab with or without chemotherapy

Exclusion criteria

Exclusion criteria: 1. Previous use of rituximab 2. Pregnant or lactating women 3. Patients taking antihistamines in the 3 days before the skin testing 4. Use of systemic corticosteroids for more than 7 days or dose equivalent of more than 100mg of prednisolone (use of steroids upto 100mg dose equivalent of prednisolone upto 7 days as part of prephase chemotherapy is allowed) 4. Patients with skin lesions including infection, dermatitis, trauma, or scarring in both arms 5. History of Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)

Design outcomes

Primary

Measure	Time frame
Incidence of hypersensitivity reactions (HSRs) during the first rituximab infusionTimepoint: During first rituximab infusion	—

Secondary

Measure	Time frame
1. To compare the severity of HSRs in between the skin test guided administration arm vs standard infusion arm (as per CTCAE criteria and modified Brown criteria)Timepoint: During first rituximab infusion;2. To compare the type of HSR phenotype (Type I or Cytokine release or Mixed phenotype) in both armsTimepoint: During first rituximab infusion;3. To compare the frequency of interruptions and need for interventions during rituximab in both armsTimepoint: During first rituximab infusion;4. To compare the incidence of HSRs in the second cycle of rituximab in both armsTimepoint: During second rituximab infusion;To analyse the baseline and change in levels of serum biomarkers (serum tryptase level, IL-6 level) and its role in predicting the phenotype of HSRsTimepoint: During first rituximab infusion;To explore the development of anti-rituximab antibodies and its correlation with the development of HSRs in both armTimepoint: During initial 3 cycles of rituximab	—

Measure

Time frame

1. To compare the severity of HSRs in between the skin test guided administration arm vs standard infusion arm (as per CTCAE criteria and modified Brown criteria)Timepoint: During first rituximab infusion;2. To compare the type of HSR phenotype (Type I or Cytokine release or Mixed phenotype) in both armsTimepoint: During first rituximab infusion;3. To compare the frequency of interruptions and need for interventions during rituximab in both armsTimepoint: During first rituximab infusion;4. To compare the incidence of HSRs in the second cycle of rituximab in both armsTimepoint: During second rituximab infusion;To analyse the baseline and change in levels of serum biomarkers (serum tryptase level, IL-6 level) and its role in predicting the phenotype of HSRsTimepoint: During first rituximab infusion;To explore the development of anti-rituximab antibodies and its correlation with the development of HSRs in both armTimepoint: During initial 3 cycles of rituximab

—

Countries

India

Contacts

Public ContactDr Shuvadeep Ganguly

Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry

sharmag77492@gmail.com8755396151

Outcome results

None listed

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