FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/090469 [Registered on: 08/07/2025] Trial Registered Prospectively
Last Modified On: 26/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare whether administering rituximab slowly based on skin test reduces allergic reactions in patients with blood cancer compared to routine administration 
Scientific Title of Study   Skin test-guided administration of Rituximab to reduce hypersensitivity reactions compared to standard administration in hematological malignancies – An investigator-initiated, randomized, open-label trial 
Trial Acronym  RITE Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mohit Sharma 
Designation  Senior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry 
Address  Department of Medical Oncology JIPMER, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  8755396151  
Fax    
Email  sharmag77492@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohit Sharma 
Designation  Senior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry 
Address  Department of Medical Oncology JIPMER, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  8755396151  
Fax    
Email  sharmag77492@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shuvadeep Ganguly 
Designation  Assistant Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry 
Address  Department of Medical Oncology JIPMER, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9654215495  
Fax    
Email  ganguly.shuvadeep@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Dhanvantari Nagar, Gorimedu, Puducherry - 605006, India 
 
Primary Sponsor  
Name  JIPMER, Pondicherry 
Address  JIPMER, Dhanvantari Nagar, Gorimedu, Pondicherry-605006 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shuvadeep Ganguly  JIPMER Pondichery  Department of Medical Oncology, JIPMER, Puducherry
Pondicherry
PONDICHERRY 		 9654215495

ganguly.shuvadeep@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee-Interventional Studies (JIPMER)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C81-C96||Malignant neoplasms of lymphoid, hematopoietic and related tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Skin Test-Guided Rituximab Administration Arm  All patients will undergo Skin test with rituximab. Patients with positive skin test will undergo rituximab administration by desensitization strategy while patients with negative skin test will undergo standard administration strategy. Duration: Only during 1st cycle of rituximab 
Comparator Agent  Standard Rituximab administration  All patients will undergo standard administration of rituximab irrespective of skin test Duration: Only during first cycle of rituximab 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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)
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Incidence of hypersensitivity reactions (HSRs) during the first rituximab infusion  During first rituximab infusion 
 
Secondary Outcome  
Outcome  TimePoints 
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)  During first rituximab infusion 
2. To compare the type of HSR phenotype (Type I or Cytokine release or Mixed phenotype) in both arms  During first rituximab infusion 
3. To compare the frequency of interruptions and need for interventions during rituximab in both arms  During first rituximab infusion 
4. To compare the incidence of HSRs in the second cycle of rituximab in both arms   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 HSRs  During first rituximab infusion 
To explore the development of anti-rituximab antibodies and its correlation with the development of HSRs in both arm  During initial 3 cycles of rituximab 
 
Target Sample Size   Total Sample Size="206"
Sample Size from India="206" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ganguly.shuvadeep@gmail.com].

  6. For how long will this data be available start date provided 01-06-2029 and end date provided 01-06-2034?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Rituximab is a widely used monoclonal antibody in the treatment of hematological malignancies. However, hypersensitivity reactions (HSRs), particularly during the first infusion, remain a major clinical challenge. These reactions range from mild infusion-related symptoms to severe anaphylaxis. Current strategies to prevent such reactions (such as universal premedication and slow infusion rates) do not account for individual immune sensitivity. This trial aims to evaluate whether a personalized, skin test-guided administration strategy can reduce the incidence and severity of HSRs compared to standard rituximab infusion protocols.

This is an investigator-initiated, open-label, randomized, parallel-group, superiority trial being conducted at JIPMER, Puducherry. Eligible adult patients (aged 18 years and above), naïve to rituximab, and planned for rituximab-based chemotherapy will be randomized in a 1 to 1 ratio into two arms. In the intervention arm (Arm A), all patients will undergo skin prick testing with undiluted rituximab. If negative, intradermal testing will follow in two steps which includes first with 1 mg per mL, and if negative, then with 10 mg per mL.  A positive response is defined as a wheal diameter increase of more than equal to 3 mm. Patients with a positive skin test will receive rituximab via a standardized 12 step desensitization protocol involving three different dilutions. Those with negative tests will receive standard infusion. In the control arm (Arm B), patients will receive rituximab through standard infusion irrespective of skin test results, which are recorded for research purposes only.

All participants will be premedicated and monitored for HSRs using standardized criteria (CTCAE v5.0 and Modified Brown). The primary outcome is the incidence of HSRs during the first rituximab infusion. Secondary outcomes include severity and phenotype of reactions, frequency of infusion interruptions, correlation with serum biomarkers (IL6, tryptase), and the presence of anti-rituximab antibodies. The trial includes screening, informed consent, baseline assessment, intervention, infusion with monitoring, biomarker evaluation, and follow-up through the second cycle. 
Close