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Etoposide

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Sirolimus

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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)

Spots Global Cancer Trial Database for Sirolimus & Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative, Matched Related Donor HCT

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