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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 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.

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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.

Conditions Studied

Acute Lymphoblastic Leukemia Mantle Cell Lymphoma Burkitt Lymphoma Lymphoblastic Lymphoma Adult T-cell Leukemia/Lymphoma Lymphoid Malignancies (New or Relapsed)

Interventions

  • DRUG Sirolimus
  • DRUG Hyper-CVAD

Study Locations (2)

Pennsylvania

  • University of Pennsylvania - Philadelphia
  • Thomas Jefferson University - Philadelphia

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2010-07
Est. Completion 2013-04
Phase Early Phase 1

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

138 total trials

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What the Registry Record Tells You About NCT01184885

The ClinicalTrials.gov registry entry for NCT01184885 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (98% lower). The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.