Rapamycin for Immunosuppression and B Cell Modulation Post Stem Cell Transplant for Acute Lymphoblastic Leukemia (ALL) - Full Text View

Sponsor:	University of Utah
Collaborator:	Children's Hospital of Philadelphia
Information provided by:	University of Utah
ClinicalTrials.gov Identifier:	NCT00795886

Purpose

OBJECTIVES:

Primary objective: Evaluate toxicity of rapamycin when used for post-bone marrow transplant graft vs. host disease prophylaxis in children with acute lymphoblastic leukemia (ALL).

Investigator initiated; four participating institutions; Phase II pilot study

Condition	Intervention	Phase
Acute Lymphoblastic Leukemia	Drug: RAPAMYCIN	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	CHP-753, Rapamycin for Immunosuppression and B Cell Modulation Post Stem Cell Transplant for Acute Lymphoblastic Leukemia (ALL)

Resource links provided by NLM:

MedlinePlus related topics: Bone Marrow Transplantation Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Sirolimus

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:

Evaluate toxicity of rapamycin when used for post-bone marrow transplant graft vs. host disease prophylaxis in children with acute lymphoblastic leukemia (ALL). [ Time Frame: 2009 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluate acute and chronic graft vs. host disease (GVHD) incidence and severity in patients receiving rapamycin for immunoprophylaxis post BMT. [ Time Frame: 2009 ] [ Designated as safety issue: Yes ]
Evaluate overall survival and event free survival in patients receiving rapamycin as GVHD prophylaxis after bone marrow transplant for relapsed ALL. [ Time Frame: 2009 ] [ Designated as safety issue: No ]
Evaluate intracellular targets of the rapamycin effect, including p70s6 kinase and P27kip1, as well as STAT5, in peripheral blood lymphocytes of BMT patients. [ Time Frame: 2009 ] [ Designated as safety issue: No ]
Evaluate the PK of sirolimus in children undergoing bone marrow transplant for relapsed ALL. [ Time Frame: 2009 ] [ Designated as safety issue: No ]

Enrollment:	10
Study Start Date:	August 2005
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Rapamycin (RAPA, RapamuneR) (sirolimus) is an immunosuppressive agent that was approved by the FDA in 1999. It is a macrocyclic lactone that is structurally similar to Tacrolimus (FK506) and binds to the same intracellular protein as FK506, FKBP1,2,3, but it has an entirely different mechanism of action and a different principal target protein. The target of the RAPA: FKBP complex is the mammalian target of rapamycin (mTOR). Unlike the calcineurin inhibitors cyclosporine (CSA) and - FK506, RAPA exerts its effects by inhibiting growth factor-driven transduction signals in the T-cell response to alloantigen, thus preventing proliferation among T and B lymphocytes3,4.

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Eligibility

Ages Eligible for Study:	up to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pediatric patients' ages (0 - 21 years) with lymphoid malignancies considered for allogeneic bone marrow transplant from HLA-identical sibling donor, single antigen mismatched related or unrelated donor marrow /PBSC or cord blood available for marrow donation.

First remission:
- if remission not achieved by day28
- high risk cytogenetic features, including t(9;22) or t(4;11) Second or third remission
Signed informed consent.

Exclusion Criteria:

1. Organ criteria:

Cardiac: ECHO shortening fraction <27%
Renal: Creatinine clearance <60 ml/min/1.73 m2
Hepatic: Bilirubin >1.5 mg/dl, transaminases <3x normal
Infection: active viral, fungal or bacterial infection including HIV.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795886

Locations

United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84112

Sponsors and Collaborators

University of Utah

Children's Hospital of Philadelphia

Investigators

Principal Investigator:

Michael Pulsipher, MD

Primary Children's Medical Center

More Information

No publications provided

Responsible Party:	Primary Children's Medical Center ( Michael Pulsipher, MD )
Study ID Numbers:	HCI # 14044
Study First Received:	November 19, 2008
Last Updated:	November 19, 2008
ClinicalTrials.gov Identifier:	NCT00795886 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Utah:

ALL
Cancer
STEM CELL TRANSPLANT

Additional relevant MeSH terms:

Sirolimus
Anti-Infective Agents
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs

Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Anti-Bacterial Agents
Leukemia
Lymphatic Diseases
Neoplasms
Antifungal Agents
Therapeutic Uses
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on February 09, 2010