Loading clinical trials...

Sirolimus & Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative, Matched Related Donor HCT | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

Sirolimus and Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative, Matched Related Donor Hematopoietic Cell Transplantation

NCT01220297•Stanford University

View on ClinicalTrials.gov

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 this drug combination. For all treatments and procedures, Study Day is based on the day of HSCT as Day 0.

Eligibility

Age

2 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Acute myelogenous leukemia (AML), beyond 2nd remission or relapsed/refractory disease, age 2 to 60 years
•AML, in first or subsequent remission or relapsed/refractory disease, age 51 to 60 years of age
•AML with multilineage dysplasia
•Acute lymphoblastic leukemia (ALL), beyond 2nd remission or relapsed/refractory disease, age 2 to 60 years
•ALL, age 51 - 60 years in first or subsequent remission or relapsed/refractory disease
•Chronic myeloid leukemia (CML), beyond 2nd chronic phase or in blast crisis
•Myelodysplastic syndrome (MDS), including World Health Organization (WHO)classifications of refractory anemia with excess blasts-1 (RAEB-1), RAEB-2 and therapy-related MDS
•MDS with poor long-term survival including myeloid metaplasia and myelofibrosis
•Myeloproliferative disorders
•High-risk non-Hodgkin lymphoma (NHL) in 1st emission
+7 more criteria

Exclusion Criteria

•Prior myeloablative allogeneic or autologous hematopoietic stem cell transplant (HSCT)
•HIV infection
•Pregnant
•Lactating
•Evidence of uncontrolled active infection
•Serum creatinine \> 1.5 mg/dL or 24-hour creatinine clearance \< 50 mL/min
•Direct bilirubin, Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2 x upper limit of normal (ULN)
•Carbon monoxide diffusing capacity (DlCO) \< 60% predicted (adults) OR and in-room air oxygen saturation \< 92% (children)
•Left ventricular ejection fraction \< 45% (adults) OR shortening fraction \< 26%(children)
•Fasting cholesterol \> 300 mg/dL or Triglycerides \> 300 mg/dL while on lipid-lowering agents.
+3 more criteria

Locations (1)

Stanford University School of Medicine

Stanford, California, United States

Key Dates

Start Date

August 1, 2006

Primary Completion Date

August 1, 2010

Completion Date

August 1, 2011

Last Updated

June 5, 2017

Enrollment

ACTUAL participants

Conditions

Hematologic DiseasesAcute-graft-versus-host DiseaseLeukemiaNon-Hodgkin Lymphoma (NHL)Hodgkin Lymphoma

Interventions

Sirolimus

DRUG

Mycophenolate mofetil (MMF)

DRUG

Carmustine

DRUG

Etoposide

DRUG

Cyclophosphamide (Cyclo, CY)

DRUG

FTBI

DRUG

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

NCT07388563

Lymphoma, T Cell, PeripheralT-cell Lymphoma+4 more

View study

RECRUITING

Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants

NCT00106925

Graft-versus-leukemiaGraft vs Host Disease+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 5, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants

Phase I Study of HC-7366 for Acute Myeloid Leukemia

Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)