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NCT01184885 · ClinicalTrials.gov registry record · Early Phase 1
A Pilot Study to Determine the Safety and Tolerability of Sirolimus Given With Hyper-CVAD Chemotherapy
A Early Phase 1 study of Acute Lymphoblastic Leukemia and Mantle Cell Lymphoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 7
- Enrollment target
- 2
- Study locations
NCT01184885: Completed Early Phase 1 study of Acute Lymphoblastic Leukemia and Mantle Cell Lymphoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
NCT01184885 is a Early Phase 1 study of Acute Lymphoblastic Leukemia and Mantle Cell Lymphoma that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 7 participants, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01184885, a Early Phase 1 study of Acute Lymphoblastic Leukemia and Mantle Cell Lymphoma, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 7 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a pilot study, assessing the feasibility, safety and toxicity of an mTOR (mammalian target of Rapamycin) inhibitor (MTI), rapamycin, when administered with HyperCVAD (Hyperfractionated Cyclophosphamide, Vincristine, Doxorubicine and Dexamethasone), with an ultimate goal to perform a phase II study to evaluate response rates and survival in adults with Acute Lymphoblastic Leukemia (ALL) and aggressive lymphoid malignancies.
Primary Outcome
This will be assessed by evaluating the tolerability of this regimen compared to historical controls who received Hyper-CVAD or Hyper-CVAD/ Rituximab regimens. The treatment will be designated feasible for an individual subject if in 80% of chemotherapy cycles the subject has count recovery that allows for starting the subsequent cycle by Day 28. Count recovery is defined as ANC (absolute neutrophil count) of \> 0.5 x 10\^9/L and platelet count \> 50 x 10\^9/L. Hyper-CVAD/Rapamycin will be deem
Conditions Studied
Interventions
- DRUG Sirolimus
- DRUG Hyper-CVAD
Study Locations (2)
Pennsylvania
- University of Pennsylvania - Philadelphia
- Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2010-07 |
| Est. Completion | 2013-04 |
| Phase | Early Phase 1 |
What the finished NCT01184885 record still lists
NCT01184885 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (98% lower).
The record links to 6 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Sirolimus is the first listed.
NCT01184885 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01184885 about?
NCT01184885 is a clinical study titled "A Pilot Study to Determine the Safety and Tolerability of Sirolimus Given With Hyper-CVAD Chemotherapy". This is a pilot study, assessing the feasibility, safety and toxicity of an mTOR (mammalian target of Rapamycin) inhibitor (MTI), rapamycin, when administered with HyperCVAD (Hyperfractionated Cyclophosphamide, Vincristine, Doxorubicine and Dexamethasone), with an ultimate goal to perform a phase II...
What is the current status of trial NCT01184885?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 7 participants. The study started on 2010-07. Estimated completion is 2013-04.
What conditions does trial NCT01184885 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Mantle Cell Lymphoma, Burkitt Lymphoma, Lymphoblastic Lymphoma, Adult T-cell Leukemia/Lymphoma.
What interventions are being tested in trial NCT01184885?
The interventions under investigation include: Sirolimus (DRUG), Hyper-CVAD (DRUG).
Who is sponsoring clinical trial NCT01184885?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01184885 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01184885's enrollment target sits among peer trials
7 126th of 131 higher than 1 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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