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NCT04050280 · ClinicalTrials.gov registry record · Phase 2
CLAG-GO for Patients With Persistent, Relapsed or Refractory AML
A Phase 2 study of Acute Myeloid Leukemia Recurrent and Acute Myeloid Leukemia, Adult, sponsored by University of Maryland, Baltimore.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
- 1
- Study location
NCT04050280: Recruiting Phase 2 study of Acute Myeloid Leukemia Recurrent and Acute Myeloid Leukemia, Adult, sponsored by University of Maryland, Baltimore.
NCT04050280 is a Phase 2 study of Acute Myeloid Leukemia Recurrent and Acute Myeloid Leukemia, Adult that is actively recruiting participants, run by University of Maryland, Baltimore. The registered enrollment target is 39 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04050280, a Phase 2 study of Acute Myeloid Leukemia Recurrent and Acute Myeloid Leukemia, Adult, is actively recruiting participants, sponsored by University of Maryland, Baltimore.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
- 1
- Study location
Study Summary
This study involves evaluating a combination of chemotherapy drugs known as "CLAG-GO" \[cladribine, cytarabine, granulocyte-colony stimulating factor (G-CSF) and gemtuzumab ozogamicin (GO)\] in the treatment of acute myeloid leukemia (AML) that has not responded well to standard therapy or has returned after an initial remission (relapsed). The trial will be conducted at the University of Maryland Greenebaum Comprehensive Cancer Center (UMGCCC). Potential participants will go through a screening period to see if they are eligible to join the study. If eligible, participants will be hospitalized for 4-5 weeks to receive study treatment with CLAG-GO, called induction chemotherapy. If tests show that the cancer is in remission after induction chemotherapy, participants may undergo further chemotherapy (known as consolidation) or may proceed with bone marrow/stem cell transplantation. Patients who receive consolidation chemotherapy and remain in remission may have up to 8 cycles of outpatient maintenance therapy. A cycle lasts about 28 days. All participants will be monitored carefully for both side effects and to see if the study treatment is working. Lab tests and exams will be conducted throughout the entire study. In addition, special studies will be done at various time points to try to understand better how the drugs work and which patients are likely to respond best.
Primary Outcome
Responses will be judged according to modified European LeukemiaNet recommendations published in 2017. Patients who achieve either 1) complete remission without minimal residual disease, 2) complete remission, or 3) complete remission with incomplete hematologic recovery will be considered responders
Conditions Studied
Interventions
- DRUG Cladribine, Cytarabine, and Granulocyte-Colony Stimulating Factor with Fractionated Gemtuzumab Ozogamicin (CLAG-GO)
Study Locations (1)
Maryland
- University of Maryland Greenebaumn Comprehensive Cancer Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2019-11-01 |
| Est. Completion | 2027-02 |
| Phase | Phase 2 |
What NCT04050280 shows while recruiting
NCT04050280 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 3 conditions, with Acute Myeloid Leukemia Recurrent appearing as the primary indexed condition, and to 1 intervention - of which Cladribine, Cytarabine, and Granulocyte-Colony Stimulating Factor with Fractionated Gemtuzumab Ozogamicin (CLAG-GO) is the first listed.
NCT04050280 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04050280 about?
NCT04050280 is a clinical study titled "CLAG-GO for Patients With Persistent, Relapsed or Refractory AML". This study involves evaluating a combination of chemotherapy drugs known as "CLAG-GO" \[cladribine, cytarabine, granulocyte-colony stimulating factor (G-CSF) and gemtuzumab ozogamicin (GO)\] in the treatment of acute myeloid leukemia (AML) that has not responded well to standard therapy or has retur...
What is the current status of trial NCT04050280?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2019-11-01. Estimated completion is 2027-02.
What conditions does trial NCT04050280 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia Recurrent, Acute Myeloid Leukemia, Adult, Acute Myeloid Leukemia, Relapsed, Adult.
What interventions are being tested in trial NCT04050280?
The interventions under investigation include: Cladribine, Cytarabine, and Granulocyte-Colony Stimulating Factor with Fractionated Gemtuzumab Ozogamicin (CLAG-GO) (DRUG).
Who is sponsoring clinical trial NCT04050280?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04050280 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04050280's enrollment target sits among peer trials
39 1459th of 2000 higher than 535 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
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