Trials Sponsors Conditions Drugs Pricing

Conditions

Acute Myelogenous Leukemia Acute Lymphoid Leukemia Myeloproliferative Disease Myelodysplastic Syndrome Chronic Myeloid Leukemia Chronic Myelomonocytic Leukemia

Keywords

bone marrow transplantationgraft versus host diseaseAcute myelogenous leukemiaAcute lymphoid leukemiaMyeloproliferative diseaseMyelodysplastic syndromeChronic myeloid leukemiachronic myelomonocytic leukemia

Outcome Measures

Primary Outcomes (1)

The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation.
The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation.
one year

Secondary Outcomes (1)

Cumulative incidence of chronic graft versus host disease, one year after bone marrow transplantation
one year

Other Outcomes (1)

Cumulative incidence of disease relapse, one year after bone marrow transplantation
one year

Study Arms (2)

Arm A

EXPERIMENTAL

Graft versus host disease prophylaxis will be done with cyclophosphamide 50 mg/kg on day +3 and day +4

Drug: ARM A Cyclophosphamide

Arm B

ACTIVE COMPARATOR

In this arm, patients will receive a combination of methotrexate and a calcineurin inhibitor as graft versus host disease prophylaxis

Drug: ARM B Calcineurin inhibitor and methotrexate

Interventions

ARM A CyclophosphamideDrug

Cyclophosphamide 50 mg/kg on day+3 and day+4 after bone marrow transplantation

Also known as: Cyclophosphamide

Arm A

ARM B Calcineurin inhibitor and methotrexateDrug

Graft versus host disease prophylaxis will be done with the combination of a calcineurin inhibitor (either tacrolimus or cyclosporine) and methotrexate

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Man or woman 18 to 60 years of age.
The patient should have a HLA matched donor

Sponsors & Collaborators

Hospital Israelita Albert Einstein
Otherlead

Study Sites (1)

Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)

São Paulo, São Paulo, 05652-000, Brazil

Related Publications (1)

Luznik L, Bolanos-Meade J, Zahurak M, Chen AR, Smith BD, Brodsky R, Huff CA, Borrello I, Matsui W, Powell JD, Kasamon Y, Goodman SN, Hess A, Levitsky HI, Ambinder RF, Jones RJ, Fuchs EJ. High-dose cyclophosphamide as single-agent, short-course prophylaxis of graft-versus-host disease. Blood. 2010 Apr 22;115(16):3224-30. doi: 10.1182/blood-2009-11-251595. Epub 2010 Feb 2.
PMID: 20124511BACKGROUND

MeSH Terms

Conditions

Leukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaMyeloproliferative DisordersMyelodysplastic SyndromesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myelomonocytic, ChronicGraft vs Host Disease

Interventions

CyclophosphamideMethotrexateCalcineurin Inhibitors

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasms

Study Officials

Paulo V Campregher, MD
Hospital Israelita Albert Einstein
PRINCIPAL INVESTIGATOR

Enrollment

3 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: MD

Study Record Dates

First Submitted

December 11, 2012

First Posted

December 13, 2012

Study Start

December 2012

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

Comparison Between Cyclophosphamide and Combination of Methotrexate + Calcineurin Inhibitor for GVHD Prophylaxis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (2)

Arm A

Arm B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (2)

Arm A

Arm B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations