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.

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. - CAMPER

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/105745

Enrollment

Registered

2026-03-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]

Interventions

Intervention1: 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, th

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Event Free Survival (EFS)Timepoint: 12 months	—

Secondary

Measure	Time frame
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.Timepoint: 24 months	—

Countries

India

Contacts

Public ContactDr Hasmukh Jain

Tata Memorial Hospital

pereira_sasha@yahoo.in7718982948

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026