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Trial record 87 of 138 for:    "T-Cell Adult Acute Lymphocytic Leukemia" | "Immunologic Factors"

Sirolimus, Tacrolimus, Thymoglobulin and Rituximab as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Haploidentical and HLA Partially Matched Donor Hematopoietic Cell Transplantation

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ClinicalTrials.gov Identifier: NCT01116232
Recruitment Status : Terminated (Lack of funding.)
First Posted : May 4, 2010
Results First Posted : December 13, 2013
Last Update Posted : March 26, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Zaid Al-Kadhimi, Barbara Ann Karmanos Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Leukemia
Lymphoma
Lymphoproliferative Disorder
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Interventions Biological: anti-thymocyte globulin
Biological: rituximab
Drug: sirolimus
Drug: tacrolimus
Other: laboratory biomarker analysis
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: management of therapy complications
Procedure: peripheral blood stem cell transplantation
Enrollment 4
Recruitment Details Cancer center clinic.
Pre-assignment Details  
Arm/Group Title Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
Hide Arm/Group Description

anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter

Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;

For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).

Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.

peripheral blood stem cell transplantation

sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow

Period Title: Overall Study
Started 4
Completed 0
Not Completed 4
Reason Not Completed
Progressive diease             4
Arm/Group Title Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
Hide Arm/Group Description

anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter

Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;

For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).

Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.

peripheral blood stem cell transplantation

sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow

Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants
50  (2.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
2
  50.0%
Male
2
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Incidence and Severity of Acute Graft-vs-host Disease (GVHD)
Hide Description [Not Specified]
Time Frame During the first six months post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.
Arm/Group Title Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
Hide Arm/Group Description:

anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter

Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;

For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).

Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.

peripheral blood stem cell transplantation

sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Time to Engraftment
Hide Description [Not Specified]
Time Frame During the first six months post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.
Arm/Group Title Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
Hide Arm/Group Description:

Anti-thymocyte globulin infuse the 1st dose, minimum of 6 hrs subsequent doses minimum of 4 hrs via a 0.22 micron in-line filter

Rituximab, total dose is 28 mg/kg divided in 2 doses (14 mg/kg, days -7 & +3) Initial infusion, start rate 50 mg/hour

Sirolimus 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).

Tacrolimus (IV) dose of 0.03 mg/kg (ideal body weight) every 24hr by continuous infusion starting on Day -3, discontinued once the pt. starts eating & the drug will then be given orally at a dose of approximately 4 times the IV dose.

.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Safety Assessment
Hide Description [Not Specified]
Time Frame During the first six months post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.
Arm/Group Title Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
Hide Arm/Group Description:

anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter

Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;

For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).

Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.

peripheral blood stem cell transplantation

sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Incidence of Chronic GVHD
Hide Description [Not Specified]
Time Frame Within two years after transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.
Arm/Group Title Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
Hide Arm/Group Description:

anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter

Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;

For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).

Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.

anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter.

rituximab: The total dose chosen

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Incidence of Infections Including Cytomegalovirus, Epstein-Barr Virus Reactivation, and Post-transplant Lymphoproliferative Disorder
Hide Description [Not Specified]
Time Frame At one year
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.
Arm/Group Title Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
Hide Arm/Group Description:

anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter

Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;

For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).

Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.

anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter.

rituximab: The total dose chosen

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Incidence of Thrombotic Microangiopathy
Hide Description [Not Specified]
Time Frame Within 100 days of HCT
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.
Arm/Group Title Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
Hide Arm/Group Description:

Anti-thymocyte globulin infuse the 1st dose, minimum of 6 hrs subsequent doses minimum of 4 hrs via a 0.22 micron in-line filter

Rituximab, total dose is 28 mg/kg divided in 2 doses (14 mg/kg, days -7 & +3) Initial infusion, start rate 50 mg/hour

Sirolimus 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).

Tacrolimus (IV) dose of 0.03 mg/kg (ideal body weight) every 24hr by continuous infusion starting on Day -3, discontinued once the pt. starts eating & the drug will then be given orally at a dose of approximately 4 times the IV dose.

.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Overall and Disease-free Survival
Hide Description [Not Specified]
Time Frame At 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.
Arm/Group Title Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
Hide Arm/Group Description:

Anti-thymocyte globulin infuse the 1st dose, minimum of 6 hrs subsequent doses minimum of 4 hrs via a 0.22 micron in-line filter

Rituximab, total dose is 28 mg/kg divided in 2 doses (14 mg/kg, days -7 & +3) Initial infusion, start rate 50 mg/hour

Sirolimus 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).

Tacrolimus (IV) dose of 0.03 mg/kg (ideal body weight) every 24hr by continuous infusion starting on Day -3, discontinued once the pt. starts eating & the drug will then be given orally at a dose of approximately 4 times the IV dose.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Immunocorrelative Studies Pre- and Periodically Post-transplantation
Hide Description [Not Specified]
Time Frame Using flow cytometry at 30, 60, 90, and 180 days post transplant.
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.
Arm/Group Title Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
Hide Arm/Group Description:

Anti-thymocyte globulin infuse the 1st dose, minimum of 6 hrs subsequent doses minimum of 4 hrs via a 0.22 micron in-line filter

Rituximab, total dose is 28 mg/kg divided in 2 doses (14 mg/kg, days -7 & +3) Initial infusion, start rate 50 mg/hour

Sirolimus 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).

Tacrolimus (IV) dose of 0.03 mg/kg (ideal body weight) every 24hr by continuous infusion starting on Day -3, discontinued once the pt. starts eating & the drug will then be given orally at a dose of approximately 4 times the IV dose.

.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
Hide Arm/Group Description

anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter

Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;

For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).

Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.

peripheral blood stem cell transplantation

sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow

All-Cause Mortality
Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
Affected / at Risk (%)
Total   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
Affected / at Risk (%)
Total   0/4 (0.00%) 
Study terminated due to lack of funding. No analysis, patient data on this protocol due to the fact that only four patients was able to be accrued.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Zaid Al-Kadhimi, M.D.
Organization: Barbara Ann Karmanos Cancer Institute
Phone: 404-778-5984
EMail: zalkadh@emory.edu
Layout table for additonal information
Responsible Party: Zaid Al-Kadhimi, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT01116232     History of Changes
Obsolete Identifiers: NCT01534767
Other Study ID Numbers: CDR0000671822
P30CA022453 ( U.S. NIH Grant/Contract )
U4781s ( Other Identifier: Genentech )
2009-150 ( Other Identifier: Barbara Ann Karmanos Cancer Institute )
First Submitted: May 3, 2010
First Posted: May 4, 2010
Results First Submitted: October 22, 2013
Results First Posted: December 13, 2013
Last Update Posted: March 26, 2019