NCT00548717

Brief Summary

This trial will test the hypothesis that the combination of sirolimus, mycophenolate mofetil, and bortezomib will be effective in preventing both acute and chronic GVHD after reduced intensity allogeneic stem cell transplantation.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2007

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 21, 2014

Completed
Last Updated

October 21, 2014

Status Verified

October 1, 2014

Enrollment Period

5.9 years

First QC Date

October 23, 2007

Results QC Date

September 29, 2014

Last Update Submit

October 20, 2014

Conditions

Graft-vs-Host Disease

Keywords

GVHDStem cell transplantationSirolimus

Outcome Measures

Primary Outcomes (1)

  • To Determine the Rate of Grade II-IV Acute GVHD When Sirolimus and Mycophenolate Mofetil or Sirolimus, Mycophenolate Mofetil and Bortezomib is Used for GVHD Prophylaxis After Allogeneic Stem Cell Transplantation in Patients With Hematologic Malignancies

    150 days

Secondary Outcomes (6)

  • Donor Stem Cell Engraftment, Including Donor-host Hematopoietic Chimerism Studies Post Transplant

    30 days

  • The Rate of Renal Insufficiency

    1 year

  • To Correlate the Serum Concentrations of Mycophenolate Mofetil and Its Metabolites With Acute GVHD Incidence

    1 year

  • Incidence of 100 Day Mortality

    100 days

  • Incidence of Chronic GVHD

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Siro/MMF

EXPERIMENTAL

Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF)

Drug: SirolimusDrug: Mycophenolate mofetil

Siro/MMF/Bort

EXPERIMENTAL

Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF) Bortezomib (Velcade) \*added with study reopening in 2012

Drug: SirolimusDrug: Mycophenolate mofetilDrug: Bortezomib

Interventions

SirolimusDRUG
Also known as: Rapamycin
Siro/MMFSiro/MMF/Bort
Mycophenolate mofetilDRUG
Also known as: Cellcept
Siro/MMFSiro/MMF/Bort
BortezomibDRUG
Also known as: Velcade
Siro/MMF/Bort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with hematologic malignancies, who are at high risk of complications after conventional myeloablative transplantation
  • Patients must have a 6/6 matched, related donor. Matching at HLA Class II will be based on PCR of sequence specific primers (SSP). Among family member transplants, serologic matching at Class I is sufficient
  • Patient age greater than 18
  • Performance status 0-2
  • Life expectancy of \> 100 days without transplantation
  • Written informed consent must be obtained in all cases from the patient

You may not qualify if:

  • Pregnancy
  • Prior Allogeneic Stem Cell Transplantation from any donor
  • Evidence of HIV infection or active Hepatitis B or C infection
  • Heart failure uncontrolled by medications
  • Total bilirubin \> 2.0 mg/dl that is due to hepatocellular dysfunction
  • AST \> 90
  • Cholesterol \> 300 mg/dl or Triglycerides \> 400 mg/dl while adequately treated
  • Uncontrolled bacterial, viral or fungal infection
  • Requirement for voriconazole at the time of hospital admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

SirolimusMycophenolic AcidBortezomib

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipidsBoronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed. Results are reported for transparency only, and should not be used to extrapolate significant conclusions.

Results Point of Contact

Title
Dr. Corey Cutler
Organization
Dana Farber Cancer Institute
Corey_Cutler@dfci.harvard.edu
617-632-3470

Study Officials

  • Corey Cutler, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 23, 2007

First Posted

October 24, 2007

Study Start

October 1, 2007

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

October 21, 2014

Results First Posted

October 21, 2014

Record last verified: 2014-10

Locations

US(1)