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Randomized Study to Compare Post Bone Marrow Transplant Cyclophosphamide With the Combination of Methotrexate Plus Calcineurin Inhibitor for Graft Versus Host Disease Prophylaxis


Phase 3
18 Years
60 Years
Open (Enrolling)
Both
Acute Myelogenous Leukemia, Acute Lymphoid Leukemia, Myeloproliferative Disease, Myelodysplastic Syndrome, Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia

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Trial Information

Randomized Study to Compare Post Bone Marrow Transplant Cyclophosphamide With the Combination of Methotrexate Plus Calcineurin Inhibitor for Graft Versus Host Disease Prophylaxis


We propose a study in which 150 patients will receive graft versus host disease prophylaxis
with cyclophosphamide 50 mg/kg on day +3 and day +4 after bone marrow transplantation, and
150 patients will receive the usual combination of methotrexate and calcineurin inhibitor.
The study was designed to last for 4 years. The primary endpoint is the rate of patients
alive, in remission and without immunosuppression, one year after transplant. The assignment
for each arm of the study will be done through simple randomization.


Inclusion Criteria:



- 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.

Exclusion Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Paulo V Campregher, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Israelita Albert Einstein

Authority:

Brazil: Agência Nacional de Vigilância Sanitária

Study ID:

GEDECH-2012

NCT ID:

NCT01749111

Start Date:

December 2012

Completion Date:

December 2017

Related Keywords:

  • Acute Myelogenous Leukemia
  • Acute Lymphoid Leukemia
  • Myeloproliferative Disease
  • Myelodysplastic Syndrome
  • Chronic Myeloid Leukemia
  • Chronic Myelomonocytic Leukemia
  • bone marrow transplantation
  • graft versus host disease
  • Acute myelogenous leukemia
  • Acute lymphoid leukemia
  • Myeloproliferative disease
  • Myelodysplastic syndrome
  • Chronic myeloid leukemia
  • chronic myelomonocytic leukemia
  • Graft vs Host Disease
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myelomonocytic, Chronic
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Acute
  • Myeloproliferative Disorders

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