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

NCT01749111 | Terminated Phase 3

• 1 other identifier: GEDECH-2012
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether cyclophosphamide post bone marrow transplant increases the rate of patients alive, in remission and without immunosuppression, one year after transplant, when compared with the combination of methotrexate and calcineurin inhibitor

Conditions

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

Keywords

bone marrow transplantation; graft versus host disease; Acute myelogenous leukemia; Acute lymphoid leukemia; Myeloproliferative disease; Myelodysplastic syndrome; Chronic myeloid leukemia; chronic 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 Cyclophosphamide DRUG

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 methotrexate DRUG

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

Also known as: Calcineurin inhibitor and methotrexate

Arm B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Man or woman 18 to 60 years of age.
• The patient should have a HLA matched donor
• The patient must need a bone marrow transplant for a malignant disease (Acute leukemia, myelodysplastic syndrome, myeloproliferative disease or myelodysplastic/myeloproliferative disease)
• Patients want to participate in the study, and able to give informed consent.

You may not qualify if:

• Previous auto o allogeneic hematopoietic stem cell transplant
• Performance Status \>2 (ECOG).
• Pregnancy
• HIV positive
• Active Infection
• Cardiac disease with ejection fraction \< 45%
• Lung disease with FEV1, FVC ou DLCO \<50% of predicted values.
• Renal Insufficiency with creatinine clearance \< 60 ml/minute.
• Liver disease with bilirubin levels \> twice the reference value or ALT or AST \> three times the normal reference.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

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

São Paulo, São Paulo, 05652-000, Brazil

Location

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: 20124511 BACKGROUND

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myeloproliferative Disorders; Myelodysplastic Syndromes; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myelomonocytic, Chronic; Graft vs Host Disease

Interventions

Cyclophosphamide; Methotrexate; Calcineurin Inhibitors

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myelodysplastic-Myeloproliferative Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Paulo V Campregher, MD

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

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 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

BR (1)