Sirolimus & Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative, Matched Related Donor HCT

Phase 2

Terminated

• Conditions: Leukemia; Acute-graft-versus-host Disease; Non-Hodgkin Lymphoma (NHL); Hodgkin Lymphoma; Hematologic Diseases
• Interventions: Drug: Sirolimus; Drug: Mycophenolate mofetil (MMF); Drug: Cyclophosphamide (Cyclo, CY); Drug: Carmustine; Drug: FTBI; Drug: Etoposide

• Registration Number: NCT01220297
• Lead Sponsor: Stanford University

Brief Summary

A continuation study of sirolimus and mycophenolate mofetil (MMF) for graft-vs-host disease (GvHD) prophylaxis for patients undergoing matched related allogeneic hematopoietic stem cell transplantation (HSCT) for acute and chronic leukemia, myelodysplastic syndrome (MDS), high risk non-Hodgkin lymphoma (NHL), or Hodgkin lymphoma (HL)

Detailed Description

To explore the novel combination of sirolimus and mycophenolate mofetil (MMF) as graft-vs-host disease (GvHD) prevention in human leukocyte antigen (HLA)-matched related donor peripheral blood stem cell (PBSC) or marrow transplantation (BMT), collectively hematopoietic stem cell transplantation (HSCT). This study will report the toxicities associated with th...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2009-11-24
• Primary Completion: 2010-08
• Study First Submitted QC: 2010-10-11
• Study First Posted: 2010-10-13
• Study Completion: 2011-08
• Results First Submitted: 2017-03-13
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-31
• Last Update Submitted: 2017-05-31
• Results First Posted: 2017-06-05
• Last Update Posted: 2017-06-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FTBI + Cyclophosphamide	Cyclophosphamide (Cyclo, CY)	FTBI + Cyclophosphamide followed by Sirolimus and Mycophenolate mofetil (MMF) as prophylaxis.
Carmustine Etoposide Cyclophosphamide	Mycophenolate mofetil (MMF)	Carmustine + Etoposide + Cyclophosphamide followed by Sirolimus and Mycophenolate mofetil (MMF) as prophylaxis.
Carmustine Etoposide Cyclophosphamide	Cyclophosphamide (Cyclo, CY)	Carmustine + Etoposide + Cyclophosphamide followed by Sirolimus and Mycophenolate mofetil (MMF) as prophylaxis.
FTBI + Cyclophosphamide	Mycophenolate mofetil (MMF)	FTBI + Cyclophosphamide followed by Sirolimus and Mycophenolate mofetil (MMF) as prophylaxis.
FTBI + Cyclophosphamide	FTBI	FTBI + Cyclophosphamide followed by Sirolimus and Mycophenolate mofetil (MMF) as prophylaxis.
Carmustine Etoposide Cyclophosphamide	Sirolimus	Carmustine + Etoposide + Cyclophosphamide followed by Sirolimus and Mycophenolate mofetil (MMF) as prophylaxis.
Carmustine Etoposide Cyclophosphamide	Carmustine	Carmustine + Etoposide + Cyclophosphamide followed by Sirolimus and Mycophenolate mofetil (MMF) as prophylaxis.
Carmustine Etoposide Cyclophosphamide	Etoposide	Carmustine + Etoposide + Cyclophosphamide followed by Sirolimus and Mycophenolate mofetil (MMF) as prophylaxis.
FTBI + Cyclophosphamide	Sirolimus	FTBI + Cyclophosphamide followed by Sirolimus and Mycophenolate mofetil (MMF) as prophylaxis.

Primary Outcome Measures

Name	Time	Method
Acute Graft-vs-Host Disease (GvHD) (Grade 2 to 4)	100 days post-transplant	Assessed as the incidence of grade 2 to 4 acute graft-vs-host disease (GvHD) at Day 100 post-transplant.; Stage of Acute GvHD was assessed as follows.; * Stage 1: Skin: rash \< 25% of skin. Liver: bilirubin 2 to 3 mg/dL. Gut: diarrhea \> 500 mL/day or persistent nausea with positive biopsy for GvHD; ...

Secondary Outcome Measures

Name	Time	Method
Acute GvHD (Grade 3 to 4)	100 days post-transplant	Assessed as the incidence of grade 3 to 4 acute GvHD at Day 100 post-transplant.; Stage of Acute GvHD was assessed as follows.; * Stage 1: Skin: rash \< 25% of skin. Liver: bilirubin 2 to 3 mg/dL. Gut: diarrhea \> 500 mL/day or persistent nausea with positive biopsy for GvHD; ...
Disease-free Survival (DFS)	2 years	Assessed as survival without recurrence of disease
Overall Survival	2 years	Overall survival is defined as time from enrollment to time of death or last follow-up, within 2 years.
Veno-occlusive Disease (VoD)	100 days post-transplant	Assessed as the incidence of veno-occlusive disease (VoD) at 100 days post-transplant.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States