BridgeMD
International trial in Philadelphia chromosome-positive acute lymphoblastic leukemia
EU CTIS ID: 2024-515499-12-00
What this study is testing
To compare disease-free survival (DFS) of Standard Risk (SR) pediatric Ph+ ALL treated with continuous imatinib combined with either a highrisk COG ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Patients should be enrolled on National ALL protocol prior to enrollment on EsPhALL2017/COGAALL1631. Regardless of initial frontline protocol baseline diagnostic samples must be available to develop an MRD probe. Diagnostic samples will be collected and analyzed according to the procedures of the National front-line protocol.
- 2. > 1 year and < 21 years at ALL diagnosis
- 3. New LLA diagnosis a. type B or T, or mixed phenotypic acute leukemia (MPAL meeting 2016 WHO definition) with definitive evidence of BCR-ABL1 fusion by karyotype, FISH and/or RT-PCR b. type B, with definitive evidence of ABL class fusions identified according to National/Center procedures of each participating country.
- 4. Prior Therapy for BCR-ABL1 fusion patients: a. induction therapy, which includes vincristine, a corticosteroid, usually PEG-L-Asparaginase, with or without anthracycline, and/or other standard cytotoxic chemotherapy. b. Not received more than 14 days of multiagent induction therapy beginning with the first dose of vincristine. c. May have started imatinib prior to study entry but have not received more than 14 days of imatinib.
- 5. Prior Therapy for ABL-class fusion patients: a. must have previously completed the 4 or 5 weeks of multiagent Induction chemotherapy. b. may have started imatinib during Induction IA, at the same time of or after the first vincristine dose.
- 6. Patients must have a performance status corresponding to ECOG scores of 0, 1, or 2.
You likely can't join if
- 1. Known history of chronic myelogenous leukemia (CML).
- 2. ALL developing after a previous cancer treated with cytotoxic chemotherapy.
- 3. Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
- 4. Down syndrome
- 5. Pregnancy
- 6. Breast Feeding
See the full eligibility criteria
- 1. Patients should be enrolled on National ALL protocol prior to enrollment on EsPhALL2017/COGAALL1631. Regardless of initial frontline protocol baseline diagnostic samples must be available to develop an MRD probe. Diagnostic samples will be collected and analyzed according to the procedures of the National front-line protocol.
- 2. > 1 year and < 21 years at ALL diagnosis
- 3. New LLA diagnosis a. type B or T, or mixed phenotypic acute leukemia (MPAL meeting 2016 WHO definition) with definitive evidence of BCR-ABL1 fusion by karyotype, FISH and/or RT-PCR b. type B, with definitive evidence of ABL class fusions identified according to National/Center procedures of each participating country.
- 4. Prior Therapy for BCR-ABL1 fusion patients: a. induction therapy, which includes vincristine, a corticosteroid, usually PEG-L-Asparaginase, with or without anthracycline, and/or other standard cytotoxic chemotherapy. b. Not received more than 14 days of multiagent induction therapy beginning with the first dose of vincristine. c. May have started imatinib prior to study entry but have not received more than 14 days of imatinib.
- 5. Prior Therapy for ABL-class fusion patients: a. must have previously completed the 4 or 5 weeks of multiagent Induction chemotherapy. b. may have started imatinib during Induction IA, at the same time of or after the first vincristine dose.
- 6. Patients must have a performance status corresponding to ECOG scores of 0, 1, or 2.
- 7. Adequate liver function.
- 8. Adequate cardiac function.
- 9. Adequate renal function.
- 1. Known history of chronic myelogenous leukemia (CML).
- 2. ALL developing after a previous cancer treated with cytotoxic chemotherapy.
- 3. Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
- 4. Down syndrome
- 5. Pregnancy
- 6. Breast Feeding
- 7. Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of treatment according to protocol.
- 8. Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block.
- 9. Prior treatment with dasatinib, or any TKI inhibitor other than imatinib.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.