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

Phase 3

Completed

• Conditions: Acute Leukemia; Chronic Myelogenous Leukemia; Myelodysplastic Syndrome
• Interventions: Procedure: Bone marrow transplantation; Procedure: Peripheral blood stem cell transplantation

• Registration Number: NCT01020175
• Lead Sponsor: European Society for Blood and Marrow Transplantation

Brief 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.

Detailed 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

Study Timeline

• Study Start: 1995-01
• Primary Completion: 1999-12
• Study Completion: 2002-12
• Status Verified: 2009-11
• Study First Submitted: 2009-11-23
• Study First Submitted QC: 2009-11-23
• Last Update Submitted: 2009-11-23
• Study First Posted: 2009-11-25
• Last Update Posted: 2009-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bone marrow transplantation	Bone marrow transplantation	Patients received bone marrow transplantation
Peripheral blood stem cell transplantation	Peripheral blood stem cell transplantation	Patients received filgrastim-mobilized peripheral blood stem cell transplantation

Primary Outcome Measures

Name	Time	Method
The primary end point of the study was the maximum grade of acute graft versus host (GVH) disease observed in the recipient.

Secondary Outcome Measures

Name	Time	Method
Incidence of acute GVH disease grade II or above
Time to acute GVH disease
Time to an unsupported platelet count of 20 _ 109/L and 50 _ 109/L
Time to absolute neutrophil count (ANC) of 0.5 x 10e9/L and 1 x 10e9/L
Incidence and severity of chronic GVH disease
Leukemia-free survival
Overall survival

Trial Locations

Locations (1)

Dr. Norbert Schmitz; 🇩🇪 Hamburg, Germany