NCT01244906 · REGISTRY CONDITION SEARCH

Post-transplant Cyclophosphamide and Sirolimus Following Reduced Intensity Conditioning (RIC) Transplant

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2015-05-01

This trial will evaluate the safety and efficacy of post-transplant Cy and sirolimus following reduced intensity allogeneic SCT. It is hoped that the combination of a reduced intensity preparative regimen with a calcineurin-free GVHD prophylaxis regimen will decrease the risk of acute and chronic GVHD, by both limiting mucosal toxicity and augmenting immune reconstitution, thereby improving the safety of the procedure. The past experience with post-transplant Cy suggests that SCT recipients will attain rapid donor T cell chimerism, which the investigators hope will translate into improved disease control through the well documented graft-versus-malignancy effects of donor T cells.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Incidence of GVHD

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outcome · POSTED

Incidence of Absolute Neutrophil Count (ANC)/Platelet Engraftment

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outcome · POSTED

Number of Participants With Non-Relapse Mortality

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outcome · POSTED

Number of Patients With Disease Free Survival at 2 Years

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outcome · POSTED

Number of Patients to Achieve Full Donor Chimerism

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outcome · POSTED

Number of Patients With Overall Survival at 2 Years.

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Availability of a 7/8 or 8/8 (HLA-A, B, C, DR) related or unrelated donor * Age 18-75 * One of the following high-risk malignancies * Chronic Myelogenous Leukemia * Acute Myelogenous Leukemia * Myelodysplastic Syndrome * Myelofibrosis * Acute Lymphocytic Leukemia * Acute Lymphoblastic Lymphoma * Chronic Lymphocytic Leukemia * Prolymphocytic Leukemia * Low-grade non-Hodgkin's Lymphoma * Mantle Cell Lymphoma * Hodgkin Lymphoma * Myeloma Exclusion Criteria: * Poor cardiac function (EF \<40%) * Poor pulmonary function (FEV1 and FVC \<50% predicted) * Poor liver function (bilirubin \>/= 2 mg/dl not due to hemolysis, Gilbert's or primary malignancy) * Poor renal function (creatinine \>/= 2 mg/dl or creatinine clearance \<40mL/min) * Karnofsky status \<70% * HIV positive
healthy Volunteers: false
maximum Age: 75 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
intervention Names
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
label
Reduced Intensity Allogeneic Stem Cell Transplantation
type
EXPERIMENTAL

interventions

arm Group Labels
Reduced Intensity Allogeneic Stem Cell Transplantation
description
Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
name
Allogeneic Hematopoietic Stem Cell Transplantation
type
PROCEDURE

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 26
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
To estimate the incidence of graft-versus-host disease (GVHD) when utilizing post-transplant cyclophosphamide (Cy) and sirolimus for GVHD prophylaxis following reduced intensity allogeneic hematopoietic stem cell transplantation (SCT) in patients with high risk hematologic malignancies.
measure
Incidence of GVHD
time Frame
1 year

secondary Outcomes

description
To estimate the incidence of neutrophil and platelet engraftment
measure
Incidence of Absolute Neutrophil Count (ANC)/Platelet Engraftment
time Frame
Approximately Day 30
measure
Number of Participants With Non-Relapse Mortality
time Frame
1 year
measure
Number of Patients With Disease Free Survival at 2 Years
time Frame
2 years
description
Characterize rate of achievement of full donor chimerism
measure
Number of Patients to Achieve Full Donor Chimerism
time Frame
1 year
measure
Number of Patients With Overall Survival at 2 Years.
time Frame
2 years

Full study description

brief Summary: This trial will evaluate the safety and efficacy of post-transplant Cy and sirolimus following reduced intensity allogeneic SCT. It is hoped that the combination of a reduced intensity preparative regimen with a calcineurin-free GVHD prophylaxis regimen will decrease the risk of acute and chronic GVHD, by both limiting mucosal toxicity and augmenting immune reconstitution, thereby improving the safety of the procedure. The past experience with post-transplant Cy suggests that SCT recipients will attain rapid donor T cell chimerism, which the investigators hope will translate into improved disease control through the well documented graft-versus-malignancy effects of donor T cells.

Source references

references

citation
Szydlo R, Goldman JM, Klein JP, Gale RP, Ash RC, Bach FH, Bradley BA, Casper JT, Flomenberg N, Gajewski JL, Gluckman E, Henslee-Downey PJ, Hows JM, Jacobsen N, Kolb HJ, Lowenberg B, Masaoka T, Rowlings PA, Sondel PM, van Bekkum DW, van Rood JJ, Vowels MR, Zhang MJ, Horowitz MM. Results of allogeneic bone marrow transplants for leukemia using donors other than HLA-identical siblings. J Clin Oncol. 1997 May;15(5):1767-77. doi: 10.1200/JCO.1997.15.5.1767.
pmid
9164184
type
BACKGROUND
citation
de Witte T, Brand R, van Biezen A, Mufti G, Ruutu T, Finke J, von dem Borne P, Vitek A, Delforge M, Alessandrino P, Harlahakis N, Russell N, Martino R, Verdonck L, Kroger N, Niederwieser D; European Blood and Marrow Transplantation Group (EBMT), Chronic Leukemia Working Party (CLWP)-MDS subcommittee. Allogeneic stem cell transplantation for patients with refractory anaemia with matched related and unrelated donors: delay of the transplant is associated with inferior survival. Br J Haematol. 2009 Sep;146(6):627-36. doi: 10.1111/j.1365-2141.2009.07809.x. Epub 2009 Jul 14.
pmid
19604243
type
BACKGROUND
citation
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pmid
19151786
type
BACKGROUND
citation
Mielcarek M, Storer BE, Sandmaier BM, Sorror ML, Maloney DG, Petersdorf E, Martin PJ, Storb R. Comparable outcomes after nonmyeloablative hematopoietic cell transplantation with unrelated and related donors. Biol Blood Marrow Transplant. 2007 Dec;13(12):1499-507. doi: 10.1016/j.bbmt.2007.09.004.
pmid
18022580
type
BACKGROUND
citation
Taylor PA, Lees CJ, Blazar BR. The infusion of ex vivo activated and expanded CD4(+)CD25(+) immune regulatory cells inhibits graft-versus-host disease lethality. Blood. 2002 May 15;99(10):3493-9. doi: 10.1182/blood.v99.10.3493.
pmid
11986199
type
BACKGROUND
citation
Edinger M, Hoffmann P, Ermann J, Drago K, Fathman CG, Strober S, Negrin RS. CD4+CD25+ regulatory T cells preserve graft-versus-tumor activity while inhibiting graft-versus-host disease after bone marrow transplantation. Nat Med. 2003 Sep;9(9):1144-50. doi: 10.1038/nm915. Epub 2003 Aug 17.
pmid
12925844
type
BACKGROUND
citation
Trenado A, Charlotte F, Fisson S, Yagello M, Klatzmann D, Salomon BL, Cohen JL. Recipient-type specific CD4+CD25+ regulatory T cells favor immune reconstitution and control graft-versus-host disease while maintaining graft-versus-leukemia. J Clin Invest. 2003 Dec;112(11):1688-96. doi: 10.1172/JCI17702.
pmid
14660744
type
BACKGROUND
citation
Zhao D, Zhang C, Yi T, Lin CL, Todorov I, Kandeel F, Forman S, Zeng D. In vivo-activated CD103+CD4+ regulatory T cells ameliorate ongoing chronic graft-versus-host disease. Blood. 2008 Sep 1;112(5):2129-38. doi: 10.1182/blood-2008-02-140277. Epub 2008 Jun 12.
pmid
18550852
type
BACKGROUND
citation
Zorn E, Kim HT, Lee SJ, Floyd BH, Litsa D, Arumugarajah S, Bellucci R, Alyea EP, Antin JH, Soiffer RJ, Ritz J. Reduced frequency of FOXP3+ CD4+CD25+ regulatory T cells in patients with chronic graft-versus-host disease. Blood. 2005 Oct 15;106(8):2903-11. doi: 10.1182/blood-2005-03-1257. Epub 2005 Jun 21.
pmid
15972448
type
BACKGROUND
citation
Rieger K, Loddenkemper C, Maul J, Fietz T, Wolff D, Terpe H, Steiner B, Berg E, Miehlke S, Bornhauser M, Schneider T, Zeitz M, Stein H, Thiel E, Duchmann R, Uharek L. Mucosal FOXP3+ regulatory T cells are numerically deficient in acute and chronic GvHD. Blood. 2006 Feb 15;107(4):1717-23. doi: 10.1182/blood-2005-06-2529. Epub 2005 Nov 8.
pmid
16278306
type
BACKGROUND
citation
Rezvani K, Mielke S, Ahmadzadeh M, Kilical Y, Savani BN, Zeilah J, Keyvanfar K, Montero A, Hensel N, Kurlander R, Barrett AJ. High donor FOXP3-positive regulatory T-cell (Treg) content is associated with a low risk of GVHD following HLA-matched allogeneic SCT. Blood. 2006 Aug 15;108(4):1291-7. doi: 10.1182/blood-2006-02-003996. Epub 2006 Apr 20.
pmid
16627754
type
BACKGROUND
citation
Coenen JJ, Koenen HJ, van Rijssen E, Kasran A, Boon L, Hilbrands LB, Joosten I. Rapamycin, not cyclosporine, permits thymic generation and peripheral preservation of CD4+ CD25+ FoxP3+ T cells. Bone Marrow Transplant. 2007 May;39(9):537-45. doi: 10.1038/sj.bmt.1705628. Epub 2007 Mar 12.
pmid
17351648
type
BACKGROUND

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice