Azacitidine + Chemotherapy for Acute Lymphoblastic Leukemia

Recruiting at 184 trial locations

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Cytotoxic chemotherapy

Disqualifiers: Down syndrome, Secondary B-ALL, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

78 Participants Needed

Trial Summary

What is the purpose of this trial?

This pilot phase II trial studies the side effects of azacitidine and combination chemotherapy in infants with acute lymphoblastic leukemia and KMT2A gene rearrangement. Drugs used in chemotherapy, such as methotrexate, prednisolone, daunorubicin hydrochloride, cytarabine, dexamethasone, vincristine sulfate, pegaspargase, hydrocortisone sodium succinate, azacitidine, cyclophosphamide, mercaptopurine, leucovorin calcium, and thioguanine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug may kill more cancer cells.

Research Team

Rishi S Kotecha

Principal Investigator

Children's Oncology Group

Eligibility Criteria

This trial is for infants over 36 weeks gestational age with newly diagnosed B lymphoblastic leukemia or acute leukemia of ambiguous lineage, without Down syndrome or prior malignancies treated with cytotoxic chemotherapy. They must not have received previous cancer treatments, except certain steroids and intrathecal drugs.

Inclusion Criteria

My baby was born after 36 weeks of pregnancy.

My CNS status was checked before any major cancer treatment, except steroids.

My leukemia is newly diagnosed and falls under B lymphoblastic or mixed phenotype.

Exclusion Criteria

I haven't had chemotherapy for my current B-ALL or any other cancer, except for steroids or specific spinal treatments.

My B-ALL developed after chemotherapy for another cancer.

My leukemia does not have the KMT2A rearrangement.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Chemotherapy

Patients receive a combination of chemotherapy drugs including methotrexate, prednisolone, daunorubicin hydrochloride, cytarabine, dexamethasone, vincristine sulfate, pegaspargase, and hydrocortisone sodium succinate.

5 weeks

Azacitidine Block I

Patients receive azacitidine IV over 10-40 minutes daily for 5 days.

1 week

Consolidation

Patients receive cyclophosphamide, mercaptopurine, cytarabine, methotrexate, and hydrocortisone sodium succinate.

6 weeks

Azacitidine Block II

Patients receive azacitidine as in Azacitidine Block I.

1 week

Interim Maintenance

Patients receive mercaptopurine, methotrexate, leucovorin calcium, hydrocortisone sodium succinate, cytarabine, and pegaspargase.

4 weeks

Azacitidine Block III

Patients receive azacitidine as in Azacitidine Block I.

1 week

Delayed Intensification Part I

Patients receive pegaspargase, dexamethasone, thioguanine, vincristine sulfate, daunorubicin hydrochloride, cytarabine, and hydrocortisone sodium succinate.

4 weeks

Azacitidine Block IV

Patients receive azacitidine as in Azacitidine Block I.

1 week

Delayed Intensification Part II

Patients receive thioguanine, cyclophosphamide, and cytarabine.

2 weeks

Maintenance

Patients receive mercaptopurine, methotrexate, hydrocortisone sodium succinate, and cytarabine. Cycles repeat every 84 days for 2 years.

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment.

5 years

Treatment Details

Interventions

• Azacitidine
• Cyclophosphamide
• Cytarabine
• Daunorubicin
• Daunorubicin Hydrochloride
• Dexamethasone
• Hydrocortisone Sodium Succinate
• Laboratory Biomarker Analysis
• Leucovorin
• Leucovorin Calcium
• Mercaptopurine
• Methotrexate
• Pegaspargase
• Pharmacological Study
• Prednisolone
• Thioguanine
• Vincristine
• Vincristine Sulfate

Trial Overview The trial tests the side effects of azacitidine combined with other chemotherapy drugs in treating infant leukemia with KMT2A gene rearrangement. It aims to see if using multiple drugs can more effectively kill cancer cells by working together in different ways.

Participant Groups

Group I: Treatment (azacitidine, combination chemotherapy) Experimental Treatment 21 Interventions

See Detailed Description

Azacitidine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Vidaza for:

• Acute myeloid leukemia
• Chronic myelomonocytic leukemia
• Myelodysplastic syndromes

Approved in United States as Vidaza for:

• Myelodysplastic syndromes
• Chronic myelomonocytic leukemia

Approved in Canada as Vidaza for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

Approved in Japan as Vidaza for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+