A study in patients with acute lymphoblastic leukaemia to compare two ways of giving steroids during initial treatment, to see which is more effective and safer.

Comparison of alternate-week versus continuous steroid therapy during induction in acute lymphoblastic leukemia: A study on efficacy and toxicity outcome - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/095643

Enrollment

118

Registered

2025-10-06

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

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: Alternate week steroid therapy: Prednisolone (steroid) will be given orally at 60mg/m2 alternate weekly during the 4 weeks of induction therapy in patients with acute lymphoblastic leuk

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed B-ALL and T-ALL ECOG 0-2 and fit to start therapy

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
To compare the rate of complete remission (CR), including measurable residual disease (MRD) negativity, at the end of induction (Day 29- 35) between patients receiving intermittent versus continuous steroid therapy. To assess the rate of early mortality (induction deaths) in each treatment group.Timepoint: To compare the rate of complete remission (CR), including measurable residual disease (MRD) negativity, at the end of induction (Day 29- 35) between patients receiving intermittent versus continuous steroid therapy. To assess the rate of early mortality (induction deaths) in each treatment group. Patients will be assessed at the end of induction (4 weeks).	—

Measure

Time frame

To compare the rate of complete remission (CR), including measurable residual disease (MRD) negativity, at the end of induction (Day 29- 35) between patients receiving intermittent versus continuous steroid therapy. To assess the rate of early mortality (induction deaths) in each treatment group.Timepoint: To compare the rate of complete remission (CR), including measurable residual disease (MRD) negativity, at the end of induction (Day 29- 35) between patients receiving intermittent versus continuous steroid therapy. To assess the rate of early mortality (induction deaths) in each treatment group. Patients will be assessed at the end of induction (4 weeks).

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Secondary

Measure	Time frame
To compare the incidence of induction-related infections (bacterial, fungal, and viral), graded by CTCAE v5.0, during the first 5 weeks of treatment between the two steroid regimens.Timepoint: 5 weeks;To assess and compare the frequency of steroid-related complications in both groups.Timepoint: End of induction;To evaluate leukemia-free survival and overall survival at 6 months and 12 months in each group.Timepoint: 6 months and 12 months	—

Measure

Time frame

To compare the incidence of induction-related infections (bacterial, fungal, and viral), graded by CTCAE v5.0, during the first 5 weeks of treatment between the two steroid regimens.Timepoint: 5 weeks;To assess and compare the frequency of steroid-related complications in both groups.Timepoint: End of induction;To evaluate leukemia-free survival and overall survival at 6 months and 12 months in each group.Timepoint: 6 months and 12 months

—

Countries

India

Contacts

Public ContactAbirami

All India institute of medical sciences, New Delhi

mukulhemat@gmail.com8800898282

Outcome results

None listed

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