Peripheral Blood (PB) Versus Bone Marrow (BM) in Allogeneic Stem Cell Transplantation

Myelodysplastic Syndrome Clinical Trial

Official title:

A Phase III, Randomized, Multicentre Trial Comparing Allogeneic Filgrastim Mobilised Peripheral Blood Progenitor Cell Transplantation (PBPCT) With Allogeneic Bone Marrow Transplantation (BMT) in Patients With Acute Leukemia, Chronic Myelogenous Leukemia or Myelodysplastic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01020175
• Other study ID #: GCSF-940136
• Status: Completed
• Phase: Phase 3
• First received: November 23, 2009
• Last updated: November 23, 2009
• Start date: January 1995
• Est. completion date: December 2002

Study information

• Verified date: November 2009
• Source: European Group for Blood and Marrow Transplantation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

350 patients with early leukemias were assigned to receive peripheral blood or bone marrow transplantation; the occurrence of acute and chronic graft versus host disease, survival, transplantation-related mortality, and relapse rates were compared.

Description:

The trial was designed to investigate the safety and outcome of allogeneic filgrastim-mobilized PBPCT compared with allogeneic BMT in patients with standard-risk leukemia. A total of 350 patients between 18 and 55 years of age with acute leukemias in remission or chronic myelogenous leukemia in first chronic phase were randomized to receive either filgrastim-mobilized peripheral blood progenitor cells or bone marrow cells from HLA-identical sibling donors after standard high-dose chemoradiotherapy. The study was approved by the ethics committees of all participating centers, and all patients and donors gave informed consent before any study-related procedure was performed. Donor-recipient pairs were randomized to undergo either BMT or PBPCT. Randomization was carried out centrally at the International Institute for Drug Development (id2), Brussels, Belgium, and used the minimization method to allocate donor and recipient to allogeneic BMT or PBPCT. The randomization strata were as follows: diagnosis (chronic myeloid leukemia [CML] vs other diseases), sex mismatch of donor and recipient, and whether the donor was female and nulliparous. Follow-up visits were scheduled for 6, 12, 24, and 36 months after the date of transplantation.

Neutrophil and platelet recovery occurred significantly faster after transplantation of peripheral blood progenitor cells than after bone marrow transplantation. Acute graft versus host disease of grades II-IV was significantly more frequent in recipients of peripheral blood progenitor cells than in recipients of marrow cells The cumulative incidence of chronic graft versus host disease was higher with peripheral blood progenitor cells than with bone marrow cells

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: December 2002
• Est. primary completion date: December 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Patients with either diagnosis of AML in first or second remission, in first untreated relapse (blast count in marrow < 30%); ALL in first or second remission, in first untreated relapse (blast count in marrow < 30%); CML in first chronic phase, in first accelerated phase (total blast and promyelocytes in marrow and or peripheral blood < 30%) or MDS (excluding RAEB-t).

• Age between 18 and 55 years.

• ECOG performance status between 0,1 or 2.

• HLA-identical sibling donor.

• Written informed consent.

Exclusion Criteria:

• Serum creatinine more than 10% above the normal range for the centre.

• Left ventricular size and function abnormal.

• DLCO < 50%.

• Bilirubin > 2mg/dL (34.2 µmol/L).

• Splenectomised or splenic irradiation.

• Psychiatric, addictive, or any other disorder, which compromises ability to give truly informed consent for participation in this study.

• Currently receiving non-licensed drugs which may affect GVHD or engraftment.

• Pregnant or lactating women.

• Known sensitivity to E.coli derived products.

• HIV positive.

• Previously received BM/PBPC transplant.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Leukemia
• Chronic Myelogenous Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia

Intervention

Procedure:
• Bone marrow transplantation
Patients received bone marrow transplantation
• Peripheral blood stem cell transplantation
Patients received filgrastim-mobilized peripheral blood stem cell transplantation

Locations

Country	Name	City	State
Germany	Dr. Norbert Schmitz	Hamburg

Sponsors (3)

Lead Sponsor	Collaborator
European Group for Blood and Marrow Transplantation	Amgen, Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary end point of the study was the maximum grade of acute graft versus host (GVH) disease observed in the recipient.			No
Secondary	Incidence of acute GVH disease grade II or above			No
Secondary	Time to acute GVH disease			No
Secondary	Time to an unsupported platelet count of 20 _ 109/L and 50 _ 109/L			No
Secondary	Time to absolute neutrophil count (ANC) of 0.5 x 10e9/L and 1 x 10e9/L			No
Secondary	Incidence and severity of chronic GVH disease			No
Secondary	Leukemia-free survival			No
Secondary	Overall survival			No

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