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A Pilot Study to Determine the Safety and Tolerability of Sirolimus Given With Hyper-CVAD Chemotherapy
NCT01184885 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01184885
The ClinicalTrials.gov registry entry for NCT01184885 describes a study currently listed as completed. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 26 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01184885 reports 2 study locations spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01184885?
The interventions under investigation include: Sirolimus (DRUG), Hyper-CVAD (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01184885?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 26 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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