Ignite Creation Date:
2024-05-05 @ 10:47 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01184885
Status:
COMPLETED
Last Update Posted:
2017-12-18
First Post:
2010-08-17
Brief Title:
A Pilot Study to Determine the Safety and Tolerability of Sirolimus Given With Hyper-CVAD Chemotherapy
Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
A Pilot Study of Hyperfractionated Cyclophosphamide Vincristine Doxorubicin and Dexamethasone Hyper-CVAD With Sirolimus for the Treatment of Adult Acute Lymphoblastic Leukemia and Aggressive Lymphoid Malignancies
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
The primary objective of this trial is to characterize the feasibility safety and tolerability of therapy with Hyper-CVAD and Rapamycin in adults with ALL and other aggressive lymphoid malignancies
This study will evaluate the effectiveness of Rapamycin given in combination with Hyper-CVAD during A treatment cycles and Methotrexate and Cytarabine in B treatment cycles Both cycles will also contain the drug Rituximab if the patient has a B cell type of leukemia or lymphoma
This combination of drugs are being studied to determine whether or not these drugs will have an effect in treating this disease
Current therapeutic regimens for induction of remission in ALL are broadly similar There is no single best regimen for induction therapy The hyper-CVAD regimen is of particular interest because it does not include asparaginase as part of the therapeutic regimen and the results of induction are similar to other published regimens
The HyperCVAD regimen with or without rituximab is also an accepted induction regimen for lymphoblastic lymphoma Burkitt and Burkitt like lymphoma Mantle Cell Lymphoma and ALL in the elderly The regimen has also been used as a salvage regimen in patients with the above diagnoses who have relapsed after another induction regimen
This trial will add a novel agent an mTOR inhibitor MTI rapamycin to act synergistically with the HyperCVAD regimen This is a pilot study assessing the feasibility safety and toxicity of this regimen with an ultimate goal to perform a phase II study to evaluate response rates and survival
This is a pilot study of the Hyper-CVAD regimen with Rapamycin for the treatment of adults with acute lymphoblastic leukemia or other aggressive lymphoid malignancies The standard Hyper-CVAD regimen will be used with the addition of the investigational agent Rapamycin Hyper-CVAD alone is one of the current standard induction and salvage regimens used to treat ALL and other aggressive lymphoid malignancies
Subjects included will have either de novo relapsed or refractory ALL or another aggressive lymphoid malignancy
Chemotherapy will consist of 4 A cycles alternating with 4 B cycles every 21 days or as count recovery allows at least 14 days apart as follows 1A 1B 2A 2B 3A 3B 4A 4B This is dependent on white blood cell count recovery
This study will evaluate the effectiveness of Rapamycin given in combination with Hyper-CVAD during A treatment cycles and Methotrexate and Cytarabine in B treatment cycles Both cycles will also contain the drug Rituximab if the patient has a B cell type of leukemia or lymphoma
This combination of drugs are being studied to determine whether or not these drugs will have an effect in treating this disease
Current therapeutic regimens for induction of remission in ALL are broadly similar There is no single best regimen for induction therapy The hyper-CVAD regimen is of particular interest because it does not include asparaginase as part of the therapeutic regimen and the results of induction are similar to other published regimens
The HyperCVAD regimen with or without rituximab is also an accepted induction regimen for lymphoblastic lymphoma Burkitt and Burkitt like lymphoma Mantle Cell Lymphoma and ALL in the elderly The regimen has also been used as a salvage regimen in patients with the above diagnoses who have relapsed after another induction regimen
This trial will add a novel agent an mTOR inhibitor MTI rapamycin to act synergistically with the HyperCVAD regimen This is a pilot study assessing the feasibility safety and toxicity of this regimen with an ultimate goal to perform a phase II study to evaluate response rates and survival
This is a pilot study of the Hyper-CVAD regimen with Rapamycin for the treatment of adults with acute lymphoblastic leukemia or other aggressive lymphoid malignancies The standard Hyper-CVAD regimen will be used with the addition of the investigational agent Rapamycin Hyper-CVAD alone is one of the current standard induction and salvage regimens used to treat ALL and other aggressive lymphoid malignancies
Subjects included will have either de novo relapsed or refractory ALL or another aggressive lymphoid malignancy
Chemotherapy will consist of 4 A cycles alternating with 4 B cycles every 21 days or as count recovery allows at least 14 days apart as follows 1A 1B 2A 2B 3A 3B 4A 4B This is dependent on white blood cell count recovery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2009-35 | OTHER | CCRRC | None |