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NCT03147612 · ClinicalTrials.gov registry record · Phase 2
Low-Intensity Chemotherapy, Ponatinib and Blinatumomab in Treating Patients With Philadelphia Chromosome-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia
A Phase 2 study of Acute Lymphoblastic Leukemia and Refractory Acute Lymphoblastic Leukemia, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT03147612: Active Phase 2 study of Acute Lymphoblastic Leukemia and Refractory Acute Lymphoblastic Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT03147612 is a Phase 2 study of Acute Lymphoblastic Leukemia and Refractory Acute Lymphoblastic Leukemia that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 22 participants, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03147612, a Phase 2 study of Acute Lymphoblastic Leukemia and Refractory Acute Lymphoblastic Leukemia, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well low-intensity chemotherapy and ponatinib work in treating patients with Philadelphia chromosome-positive and/or BCR-ABL positive acute lymphoblastic leukemia that may have come back or is not responding to treatment. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, dexamethasone, methotrexate, and cytarabine, 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. Immunotherapy with rituximab and blinatumomab, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Granulocyte colony stimulating factor helps the bone marrow make recover after treatment. Giving low-intensity chemotherapy, ponatinib, and blinatumomab may work better in treating patients with acute lymphoblastic leukemia.
Primary Outcome
The CMR rate within the first 3 courses for cohort 1 or rate within the first 2 courses for cohort 2 will be estimated along with the 95% credible intervals. Similar analyses will be performed for estimating the rate of complete cytogenetic response and major molecular response rates.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Cytarabine
- BIOLOGICAL Filgrastim
- BIOLOGICAL Blinatumomab
- DRUG Methotrexate
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2018-02-08 |
| Est. Completion | 2027-02-28 |
| Phase | Phase 2 |
What the registry record for NCT03147612 still lists
NCT03147612 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (94% lower).
The record links to 6 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03147612 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03147612 about?
NCT03147612 is a clinical study titled "Low-Intensity Chemotherapy, Ponatinib and Blinatumomab in Treating Patients With Philadelphia Chromosome-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia". This phase II trial studies how well low-intensity chemotherapy and ponatinib work in treating patients with Philadelphia chromosome-positive and/or BCR-ABL positive acute lymphoblastic leukemia that may have come back or is not responding to treatment. Drugs used in chemotherapy, such as cyclophosp...
What is the current status of trial NCT03147612?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2018-02-08. Estimated completion is 2027-02-28.
What conditions does trial NCT03147612 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Refractory Acute Lymphoblastic Leukemia, Recurrent Acute Lymphoblastic Leukemia, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive.
What interventions are being tested in trial NCT03147612?
The interventions under investigation include: Cyclophosphamide (DRUG), Cytarabine (DRUG), Filgrastim (BIOLOGICAL), Blinatumomab (BIOLOGICAL), Methotrexate (DRUG).
Who is sponsoring clinical trial NCT03147612?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03147612 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03147612's enrollment target sits among peer trials
22 101st of 131 higher than 30 of 131 other Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Lymphoblastic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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