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Antineoplastic Agents

All Drugs and Chemicals

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Etoposide

Cyclophosphamide

Mycophenolic Acid

Sirolimus

Etoposide phosphate

Carmustine

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Carmustine + Etoposide + Cyclophosphamide followed by Sirolimus and Mycophenolate mofetil (MMF) as prophylaxis.

FTBI + Cyclophosphamide followed by Sirolimus and Mycophenolate mofetil (MMF) as prophylaxis.

Immunosuppressant administered orally to:

* Adults (age 14 and older), beginning on Day -3 with 12 mg loading dose, followed by 4 mg/day.
* Children \< 13 years or weighing 40 kg, beginning on Day -3 with 3 mg/m² loading dose, followed by 1 mg/ m², rounded to the nearest full milligram.

Daily dosage may be adjusted to maintain a target serum trough level of 3 to 12 ng/ml. Sirolimus dose tapering will begin at Day 100 in the absence of GvHD, with the goal of discontinuation by 6 months.

Immunosuppressant given intravenously (IV) at 15 mg/kg 3 times daily, starting on Day 0 ≥ 2 hr after the completion of the HSCT infusion. Dose of MMF will be based on actual body weight, but limited to 15 kg above ideal body weight. MMF dose tapering will begin at Day 100 in the absence of GvHD, with the goal of discontinuation by 6 months.

Mycophenolate mofetil (MMF)

For Carmustine + Etoposide + Cyclophosphamide cohort, chemotherapy administered IV on Day -6 at the lesser of 15 mg/kg or 550 mg/m².

For Carmustine + Etoposide + Cyclophosphamide cohort, chemotherapy administered IV on Day -4 at 60 mg/kg

Cyclophosphamide is a chemotherapy agent.

For FTBI + Cyclophosphamide cohort, administered IV on Day -3 and -2 at 60 mg/kg.

For Carmustine + Etoposide + Cyclophosphamide cohort, administered IV on Day -2 at 100 mg/kg

Cyclophosphamide (Cyclo, CY)

For FTBI + Cyclophosphamide cohort, administered as 1320 cGy delivered in 11 120 cGy fractions over 4 days starting on Day -7.

FTBI

Laura Johnston

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)

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.

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

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
* Stage 2: Skin: rash 25 to 50% of skin. Liver: bilirubin 3 to 6 mg/dL. Gut: diarrhea \>1000 mL/day.
* Stage 3: Skin: rash \> 50% of skin. Liver: bilirubin 6 to 15 mg/dL. Gut: diarrhea \> 1500 mL/day.
* Stage 4: Skin: generalized erythroderma with bulla formation. Liver: bilirubin \> 15 mg/dL. Gut: severe abdominal pain with or without ileus

Grade of Acute GvHD was determined as follows.

* Grade 1: Stage 1-2 Skin + No Liver stage + No Gut stage
* Grade 2: Stage 3 Skin OR Stage 1 Liver or Stage 1 Gut
* Grade 3: No Skin stage + Stage 2 to 3 Liver Stage 2 to 4 Gut
* Grade 4: Stage 4 Skin + or Stage 2 to 3 Liver + No Gut stage

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
* Stage 2: Skin: rash 25 to 50% of skin. Liver: bilirubin 3 to 6 mg/dL. Gut: diarrhea \>1000 mL/day.
* Stage 3: Skin: rash \> 50% of skin. Liver: bilirubin 6 to 15 mg/dL. Gut: diarrhea \> 1500 mL/day.
* Stage 4: Skin: generalized erythroderma with bulla formation. Liver: bilirubin \> 15 mg/dL. Gut: severe abdominal pain with or without ileus

Grade of Acute GvHD was determined as follows.

* Grade 1: Stage 1-2 Skin + No Liver stage + No Gut stage
* Grade 2: Stage 3 Skin OR Stage 1 Liver or Stage 1 Gut
* Grade 3: No Skin stage + Stage 2 to 3 Liver Stage 2 to 4 Gut
* Grade 4: Stage 4 Skin + or Stage 2 to 3 Liver + No Gut stage

Assessed as survival without recurrence of disease

Overall survival is defined as time from enrollment to time of death or last follow-up, within 2 years.

Assessed as the incidence of veno-occlusive disease (VoD) at 100 days post-transplant.

Stanford University

Associate Professor of Medicine

Graft-vs-host disease (GvHD) prophylaxis of sirolimus \& mycophenolate mofetil (MMF) after chemotherapeutic regimen of carmustine (BCNU) + etoposide (VP-16) + cyclophosphamide (Cyclo)

GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo

Graft-vs-host disease (GvHD) prophylaxis of sirolimus \& mycophenolate mofetil (MMF) after therapeutic regimen of cyclophosphamide (Cyclo) chemotherapy and fractionated total body irradiation (FTBI)

GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Acute Lymphoblastic Leukemia (ALL)

Acute Myeloid Leukemia (AML)

Biphenotypic Acute Leukaemia (BAL)

Disease Characteristics

Laura Johnston, MD

Acute Graft-vs-Host Disease (GvHD) (Grade 2 to 4)

Acute GvHD (Grade 3 to 4)

Disease-free Survival (DFS)

Overall Survival

Veno-occlusive Disease (VoD)

Sirolimus \& Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative

Graft-vs-Host Disease (GvHD) Prophlyaxis

Overall Study

Busulfan

For subjects 18-60 years old with lymphoma: (BCNU+ VP-16 +CY) BCNU 15 mg / kg (maximum dose 550 mg/m² actual body weight) on day -6. VP 60 mg / kg on day 4 and CY 100 mg / kg on day -2. Followed by Sirolimus and MMF as prophylaxis

For subjects 18-50 years old with AML, ALL or CML: (VP-16 +CY+ FBI) Patients aged 18-50 years with AML, ALL or CML: FTBI 1320 cGy delivered in 11 120 cGy fractions over 4 days on days -8 through -5. VP 60 mg / kg on day -4 and CY 60 mg / kg on day -2. Followed by Sirolimus and MMF as prophylaxis

For subjects 51-60 years with MDS, AML or ALL or 18-60 with MDS, secondary AML pr non-CML myeloproliferative disease: (BU+ VP-16 +CY) BU 1 mg/kg every 6 hours X 14 doses on days -9 through -6 with target concentration at steady state of X 800 ng / ml based on first dose pharmacokinetics. VP 60 mg / kg on day -5 and CY 45 mg / kg per day -2 days on day -3 and day -2. Followed by Sirolimus and MMF as prophylaxis

Immunosuppressant beginning day -3 with 12 mg oral loading dose, 4 mg/day orally for adults

Immunosuppressant given through IV on day 0 at 15 mg/kg twice daily ≥ 2hr after the completion for the donor cell infusion

BCNU

VP-16

For subjects aged 18-60 with lymphoma 100 mg/kg, IV For subjects aged with AML, ALL or CML 18-50 60 mg/kg, IV For subjects aged 51-60 with MDS, AML or ALL or patients age 18-60 with MDS, secondary AML or non-CML myeloproliferative disease 45 mg/kg

1320 cGy delivered in 11 120 cGy fractions over 4 day

GVHD prophylaxis of sirolimus and mycophenolate mofetil for patients undergoing matched related allogeneic transplant for acute and chronic leukemia, MDS, high risk NHL and HL

To explore the novel combination of sirolimus and mycophenolate mofetil (MMF) as graft versus host disease (GVHD) prevention in HLA matched related donor blood or marrow transplantation (BMT). This study will report the toxicities associated with this drug combination and also explore possible correlations between specific blood cell types and antibody production during this therapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sirolimus & Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative, Matched Related Donor HCT	NCT01220297	Hematologic Dis... Acute-graft-ver... Leukemia Non-Hodgkin Lym... Hodgkin Lymphom...	Sirolimus Mycophenolate m... Carmustine Etoposide Cyclophosphamid... FTBI	2 Years - 60 Years	Stanford University
Sirolimus & Mycophenolate Mofetil as GVHD Prophylaxis in Myeloablative, Matched Related Donor HCT	NCT00350181	Leukemia Lymphoma, Non-H... Hematologic Dis... Acute GVHD	Sirolimus MMF BCNU VP-16 CY FTBI BU	2 Years - 60 Years	Stanford University
Sirolimus & Mycophenolate Mofetil as GVHD Prophylaxis in Myeloablative, Matched Related Donor HCT	NCT00350181	Leukemia Lymphoma, Non-H... Hematologic Dis... Acute GVHD	Sirolimus MMF BCNU VP-16 CY FTBI BU	2 Years - 60 Years	Stanford University

Spots Global Cancer Trial Database for ftbi

Every month we try and update this database with for ftbi cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ftbi

Every month we try and update this database with for ftbi cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ftbi cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.