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NCT01861002 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of 5-Azacytidine in Combination With Chemotherapy for Children With Relapsed or Refractory ALL or AML
A Phase 1 study of Lymphoblastic Leukemia, Acute, Childhood and Myelogenous Leukemia, Acute, Childhood, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 20
- Study locations
NCT01861002: Completed Phase 1 study of Lymphoblastic Leukemia, Acute, Childhood and Myelogenous Leukemia, Acute, Childhood, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
NCT01861002 is a Phase 1 study of Lymphoblastic Leukemia, Acute, Childhood and Myelogenous Leukemia, Acute, Childhood that has completed, run by Therapeutic Advances in Childhood Leukemia Consortium. The registered enrollment target is 15 participants, below the 42-participant average among 4 other Lymphoblastic Leukemia, Acute, Childhood trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01861002, a Phase 1 study of Lymphoblastic Leukemia, Acute, Childhood and Myelogenous Leukemia, Acute, Childhood, has completed, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase I study with a conditional cohort expansion phase to evaluate the feasibility of, and to obtain preliminary efficacy data about, pretreatment with Azacytidine (AZA) for 5 days followed by fludarabine/cytarabine chemotherapy regimen in pediatric acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) patients who are refractory to primary treatment or who relapsed.
Primary Outcome
To evaluate the side effects of giving Azacytidine before and during chemotherapy using the standard drugs Fludarabine, Cytarabine, IT Cytarabine (AML patients) and IT methotrexate (ALL patients)
Conditions Studied
Interventions
- DRUG Fludarabine
- DRUG Cytarabine
- DRUG Azacytidine
- DRUG Intrathecal (IT) Cytarabine
- DRUG Intrathecal Methotrexate (IT MTX)
Study Locations (20)
California
- Childrens Hospital Los Angeles - Los Angeles
- UCSF School of Medicine - San Francisco
Ohio
- Rainbow Babies & Children's Hospital - Cleveland
- Nationwide Childrens Hospital - Columbus
Texas
- University of Texas at Southwestern - Dallas
- Cook Children's Medical Center - Fort Worth
District of Columbia
- Children's National Medical Center - Washington D.C.
Georgia
- Children's Healthcare of Atlanta, Emory University - Atlanta
Maryland
- Johns Hopkins University - Baltimore
Massachusetts
- Dana Farber - Boston
Michigan
- C.S. Mott Children's Hospital - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2013-05-22 |
| Est. Completion | 2014-07-28 |
| Phase | Phase 1 |
What the finished NCT01861002 record still lists
NCT01861002 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 42-participant average among 4 other Lymphoblastic Leukemia, Acute, Childhood trials with a reported enrollment target (64% lower).
The record links to 2 conditions, with Lymphoblastic Leukemia, Acute, Childhood appearing as the primary indexed condition, and to 5 interventions - of which Fludarabine is the first listed.
NCT01861002 names 20 study sites across 17 states, led by California, Ohio, Texas.
Frequently Asked Questions
What is clinical trial NCT01861002 about?
NCT01861002 is a clinical study titled "A Phase I Study of 5-Azacytidine in Combination With Chemotherapy for Children With Relapsed or Refractory ALL or AML". This is a Phase I study with a conditional cohort expansion phase to evaluate the feasibility of, and to obtain preliminary efficacy data about, pretreatment with Azacytidine (AZA) for 5 days followed by fludarabine/cytarabine chemotherapy regimen in pediatric acute myeloid leukemia (AML) and acute ...
What is the current status of trial NCT01861002?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2013-05-22. Estimated completion is 2014-07-28.
What conditions does trial NCT01861002 study?
This clinical trial studies the following conditions: Lymphoblastic Leukemia, Acute, Childhood, Myelogenous Leukemia, Acute, Childhood.
What interventions are being tested in trial NCT01861002?
The interventions under investigation include: Fludarabine (DRUG), Cytarabine (DRUG), Azacytidine (DRUG), Intrathecal (IT) Cytarabine (DRUG), Intrathecal Methotrexate (IT MTX) (DRUG).
Who is sponsoring clinical trial NCT01861002?
This trial is sponsored by Therapeutic Advances in Childhood Leukemia Consortium, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01861002 being conducted?
This trial has 20 study locations across California, District of Columbia, Georgia, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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