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CTRI Number  CTRI/2026/03/105745 [Registered on: 10/03/2026] Trial Registered Prospectively
Last Modified On: 06/05/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of oral maintenance treatment with 6-mercaptopurine and methotrexate in patients with relapsed or treatment-resistant B-cell acute lymphoblastic leukemia after CAR-T cell therapy. 
Scientific Title of Study   A single arm, phase II study to evaluate the efficacy of oral maintenance therapy with 6 mercaptopurine and methotrexate in patients of relapsed/refractory (R/R)-B ALL with early loss of B-cell aplasia post CAR-T infusion. 
Trial Acronym  CAMPER 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hasmukh Jain 
Designation  Professor, Medical Oncologist 
Affiliation  Tata Memorial Hospital 
Address  Room no 81, Adult Hematolymphoid Unit Department of Medical Oncology Main Building, Ground Floor Tata Memorial Hospital Parel, Mumbai
Tata Memorial Hospital, Dr. E.Borges Marg, Parel, Mumbai-400 012
Mumbai
MAHARASHTRA
400012
India 
Phone  7718982948  
Fax    
Email  dr.hkjain@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sasha Periera 
Designation  DM Medical Oncology Student (Senior Resident Second Year) 
Affiliation  Tata Memorial Hospital 
Address  Room no 81, Adult Hematolymphoid Unit Department of Medical Oncology Main Building, Ground Floor Tata Memorial Hospital Parel, Mumbai
Tata Memorial Hospital, Dr. E.Borges Marg, Parel, Mumbai-400012
Mumbai
MAHARASHTRA
400012
India 
Phone  7718982948  
Fax    
Email  pereira_sasha@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Dr Hasmukh Jain 
Designation  Professor, Medical Oncologist 
Affiliation  Tata Memorial Hospital 
Address  Room no 81, Adult Hematolymphoid Unit Department of Medical Oncology Main Building, Ground Floor Tata Memorial Hospital Parel, Mumbai
Tata Memorial Hospital, Dr. E.Borges Marg, Parel, Mumbai-400 012
Mumbai
MAHARASHTRA
400012
India 
Phone  7718982948  
Fax    
Email  dr.hkjain@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Tata Memorial Hospital, Dr.E.Borges Marg Parel, Mumbai, 400012  
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 = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hasmukh Jain  Advanced Centre For Treatment Research and Education In Cancer  Adult Hematolymphoid Unit, Department of Medical Oncology and BMT, Shanti Sadan Building, OPD Room 20, Ground Floor, ACTREC, Utsav Chowk-CISF road, Owe Camp, Kharghar, Navi Mumbai,410210
Mumbai
MAHARASHTRA 		 07718982948

dr.hkjain@gmail.com 
Dr Hasmukh Jain  Tata Memorial Hospital  81 OPD, Adult Hematolymphoid Unit, Department Medical Oncology, Main Building, Ground Floor, Dr.E.Borges Road, Parel,Mumbai-400012
Mumbai
MAHARASHTRA 		 07718982948

dr.hkjain@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-I  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C910||Acute lymphoblastic leukemia [ALL],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  6-Mercaptopurine Methotrexate  6-Mercaptopurine (oral) Dose 50mg as per BSA. If BSA is less than 1.3, then dose will 50 mg Once a day on alternate days. If BSA is between 1.3 - 1.5, then dose will be 50 mg once a day daily. If BSA is more than 1.5, then dose will be 1 tablet/2 tablet alternate days. The dose will be titrated as per tolerance. Methotrexate: Tablet(oral). 20 mg/m2 to be taken once a weekly.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Relapsed or Refractory B-ALL patients who achieved complete remission on day 28 following CAR-T infusion
2. Age greater than or equal to 15 yrs.
3. Early loss of B-cell aplasia (LBCA) defined as as peripheral B-cell count greater than or equal to 0.10 x10^9 per L or bone marrow (BM) CD19+ events greater than or equal to 0.1 percent within 6 months of CAR-T infusion
4. Without evidence of disease, defined as morphological complete remission (CR) and negative measurable residual disease (MRD) by flow cytometric analysis to a sensitivity of 0.0002 percent.
5. Ph + R per R B-ALL with RQ-PCR copy number less than 0.1 percent at day 28 post CAR-T. 
 
ExclusionCriteria 
Details  1. Age less than 15 years
2. ECOG PS : 4
3. Pregnant women
4. Those patients with contraindications for receiving 6 mercaptopurine, methotrexate such as those with known hypersensitivity to these drugs, liver and kidney dysfunction beyond pre-specified values.
5. Unwilling for participation in the study.
6. Those who are eligible for and can proceed for HSCT, re-infusion of CAR-T cells.
7. MRD positive post day 28 of CAR-T infusion.
8. CSF positive post day 28 of CAR-T infusion.
9. Ph + ALL with RQ-PCR copies greater than or equal to 0.1 percent at day 28 post CAR-T infusion. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Event Free Survival (EFS)  12 months 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of maintenance therapy with 6 mercaptopurine and methotrexate in patients of relapsed/refractory (R/R)-B ALL with early loss of B-cell
aplasia post CAR-T infusion by estimating the relapse free survival and overall survival
distributions. 		 24 months 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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 2 
Date of First Enrollment (India)   31/03/2026 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   When it comes to relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), CAR-T cell therapy has greatly improved outcomes. However, due in significant part to the short durability of CAR-T cells, over 50% of patients relapse within 1-2 years. A significant risk of relapse is linked to early loss of B-cell aplasia, which is a surrogate indicator of poor CAR-T persistence.Such high-risk patients have few management alternatives. While hematopoietic stem cell transplantation (HSCT) is successful, it is frequently not practical due to patient frailty, donor availability, and expensive cost, especially in the Indian environment. Repeat CAR-T infusion involves severe toxicity and dubious long-term benefit.
The purpose of this trial is to determine whether low-dose oral maintenance chemotherapy can increase survival and decrease relapse in B-ALL patients treated with CAR-T who exhibit early B-cell depletion.

This study aims to evaluate whether low-dose oral maintenance chemotherapy can reduce relapse and improve survival in CAR-T–treated B-ALL patients who demonstrate early loss of B-cell aplasia and are ineligible for second CAR-T infusion or HSCT. The maintenance regimen includes oral 6-mercaptopurine and methotrexate, based on their immunomodulatory role in standard B-ALL therapy.The primary objective is to assess 1-year event-free survival. Secondary objectives include evaluating the efficacy of maintenance chemotherapy in preventing relapse and improving overall outcomes in this high-risk population.

 
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